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Background: Patients surgically treated for lumbar spinal stenosis or cervical radiculopathy report improvement in approximately two out of three cases. Advancements in Machine Learning and the utility of large datasets have enabled the development of prognostic prediction models within spine surgery. This trial investigates if the use of the postoperative outcome prediction model, the Dialogue Support, can alter patient-reported outcome and satisfaction compared to current practice., Methods: This is a prospective, multicenter clinical trial. Patients referred to a spine clinic with cervical radiculopathy or lumbar spinal stenosis will be screened for eligibility. Participants will be assessed at baseline upon recruitment and at 12 months follow-up. The Dialogue Support will be used on all participants, and they will thereafter be placed into either a surgical or a non-surgical treatment arm, depending on the decision made between patient and surgeon. The surgical treatment group will be studied separately based on diagnosis of either cervical radiculopathy or lumbar spinal stenosis. Both the surgical and the non-surgical group will be compared to a retrospective matched control group retrieved from the Swespine register, on which the Dialogue Support has not been used. The primary outcome measure is global assessment regarding leg/arm pain in the surgical treatment group. Secondary outcome measures include patient satisfaction, Oswestry Disability Index (ODI), EQ-5D, and Numeric Rating Scales (NRS) for pain. In the non-surgical treatment group primary outcome measures are EQ-5D and mortality, as part of a selection bias analysis., Discussion: The findings of this study may provide evidence on whether the use of an advanced digital decision tool can alter patient-reported outcomes after surgery., Trial Registration: The trial was retrospectively registered at ClinicalTrials.gov on April 17th, 2023, NCT05817747., Protocol Version: 1., Trial Design: Clinical multicenter trial., (© 2024. The Author(s).)

Purpose: Lumbar spinal stenosis (LSS) can be surgically treated, with variable outcome. Studies have linked socioeconomic factors to outcome, but no nation-wide studies have been performed. This register-based study, including all patients surgically treated for LSS during 2008-2012 in Sweden, aimed to determine predictive factors for the outcome of surgery., Methods: Clinical and socioeconomic factors with impact on outcome in LSS surgery were identified in several high-coverage registers, e.g., the national quality registry for spine surgery (Swespine, FU-rate 70-90%). Multivariate regression analyses were conducted to assess their effect on outcome. Two patient-reported outcome measures, Global Assessment of leg pain (GA) and the Oswestry Disability Index (ODI), as well as length of sick leave after surgery were analyzed., Results: Clinical and socioeconomic factors significantly affected health outcome (both GA and ODI). Some predictors of a good outcome (ODI) were: being born in the EU, reporting no back pain at baseline, a high disposable income and a high educational level. Some factors predicting a worse outcome were previous surgery, having had back pain more than 2 years, having comorbidities, being a smoker, being on social welfare and being unemployed., Conclusions: The study highlights the relevance of adding socioeconomic factors to clinical factors for analysis of patient-reported outcomes, although the causal pathway of most predictors' impact is unknown. These findings should be further investigated in the perspective of treatment selection for individual LSS patients. The study also presents a foundation of case mix algorithms for predicting outcome of surgery for LSS. These slides can be retrieved under Electronic Supplementary Material.

Background Context: Decompression surgery for lumbar spinal stenosis (LSS) is the most common spinal procedure in the elderly. To avoid persisting low back pain, adding arthrodesis has been recommended, especially if there is a coexisting degenerative spondylolisthesis. However, this strategy remains controversial, resulting in practice-based variation., Purpose: The present study aimed to evaluate in a pragmatic study if surgical selection criteria and variation in use of arthrodesis in three Scandinavian countries can be linked to variation in treatment effectiveness., Study Design: This is an observational study based on a combined cohort from the national spine registries of Norway, Sweden, and Denmark., Patient Sample: Patients aged 50 and older operated during 2011-2013 for LSS were included., Outcome Measures: Patient-Reported Outcome Measures (PROMs): Oswestry Disability Index (ODI) (primary outcome), Numeric Rating Scale (NRS) for leg pain and back pain, and health-related quality of life (Euro-Qol-5D) were reported. Analysis included case-mix adjustment. In addition, we report differences in hospital stay., Methods: Analyses of baseline data were done by analysis of variance (ANOVA), chi-square, or logistic regression tests. The comparisons of the mean changes of PROMs at 1-year follow-up between the countries were done by ANOVA (crude) and analysis of covariance (case-mix adjustment)., Results: Out of 14,223 included patients, 10,890 (77%) responded at 1-year follow-up. Apart from fewer smokers in Sweden and higher comorbidity rate in Norway, baseline characteristics were similar. The rate of additional fusion surgery (patients without or with spondylolisthesis) was 11% (4%, 47%) in Norway, 21% (9%, 56%) in Sweden, and 28% (15%, 88%) in Denmark. At 1-year follow-up, the mean improvement for ODI (95% confidence interval) was 18 (17-18) in Norway, 17 (17-18) in Sweden, and 18 (17-19) in Denmark. Patients operated with arthrodesis had prolonged hospital stay., Conclusions: Real-life data from three national spine registers showed similar indications for decompression surgery but significant differences in the use of concomitant arthrodesis in Scandinavia. Additional arthrodesis was not associated with better treatment effectiveness., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Introduction: Swespine, the Swedish National Spine Register, has existed for 20 years and is in general use within the country since over 10 years regarding degenerative lumbar spine disorders. Today there are protocols for registering all disorders of the entire spinal column., Materials and Methods: Patient-based pre- and postoperative questionnaires, completed before surgery and at 1, 2, 5 and 10 years postoperatively. Among patient-based data are VAS pain, ODI, SF-36 and EQ-5D. Postoperatively evaluation of leg and back pain as compared to preoperatively ("global assessment"), overall satisfaction with outcome and working conditions are registered in addition to the same parameters as preoperatively evaluation. A yearly report is produced including an analytic part of a certain topic, in this issue disc prosthesis surgery. More than 75,000 surgically treated patients are registered to date with an increasing number yearly. The present report includes 7,285 patients; 1-, 2- and 5-year follow-up data of previously operated patients are also included for lumbar disorders as well as for disc prosthesis surgery., Results: For the degenerative lumbar spine disorders (disc herniation, spinal stenosis, spondylolisthesis and DDD) significant improvements are seen in all aspects as exemplified by pronounced improvement regarding EQ-5D and ODI. Results seem to be stable over time. Spinal stenosis is the most common indication for spine surgery. Disc prosthesis surgery yields results on a par with fusion surgery in disc degenerative pain. The utility of spine surgery is well documented by the results., Conclusion: Results of spine surgery as documented on a national basis can be utilized for quality assurance and quality improvement as well as for research purposes, documenting changes over time and bench marking when introducing new surgical techniques. A basis for international comparisons is also laid.

Purpose: The relatively large number of participants lost to follow-up (attrition) in spinal registers calls for studies that investigate the features of these individuals and their possible outcome. The aim was to explore the effect of attrition on patient-reported outcome in patients undergoing degenerative lumbar spine surgery. Three groups were studied: spinal stenosis (LSS), disc herniation (LDH) and degenerative disc disorder (DDD). Methods: Patients who underwent surgery for degenerative lumbar spine conditions during 2008–2012 according to registration in the Swespine national register were eligible for the study. Non-respondents were registered in Swespine prior to surgery, but not at follow-up. Swespine data were merged with hospital data from seven Swedish regions (65% of the population), Statistics Sweden, the National Patient Register and the Social Insurance Agency. Baseline characteristics of non-respondents were described and compared to those of the respondents. Coefficients from regression analyses on PROM values for respondents were used to estimate the levels of PROM values for non-respondents, assuming the same effects of baseline characteristics for the two subgroups. Regression analyses were then conducted to identify variables associated with non-response. The results from the regression analyses were used to predict outcomes for patients with the characteristics of a non-respondent. Primary outcome variable in LSS and LDH was Global Assessment for leg pain, and in DDD, Global Assessment for back pain. Results: Age, sex, educational level, smoking, living alone, being born outside the EU, previous spine surgery and unexpected events before follow-up were factors that were significantly associated with non-response. Being born inside, the EU was important in all of the studied groups (LSS: OR 0.61 p = < 0.000; LDH: OR 0.68 p = 0.001; DDD: OR 0.58 p = 0.04). For spinal stenosis patients, an unexpected event appeared particularly important (OR 3.40, p = 0.000). The predicted outcome of non-respondents was significantly worse than for respondents (LSS: 75.4% successful outcome vs. 78.7%; LDH: 53.9% vs. 58.2%; DDD: 62.7% vs. 67.5%. P-value in all groups = < 0.000). Conclusion: Attrition in Swespine cannot be ignored, as non-respondents were predicted to have worse outcome. The effect of attrition bias should always be considered when contemplating outcome recorded in a quality register with patients lost to follow-up. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the outcome of degenerative lumbar spine surgery in a credible way, patient-reported outcome measures (PROMs) should be assessed after an adequate follow-up period. Most authors/journals consider a follow-up period of less than two years to be too short. The purpose of this study was to explore the possibility of restricting follow-up to one year.Methods: Adult patients operated between 1998 and 2017 were retrieved from Swespine (Lumbar Disc Herniation n = 31,314, Lumbar Spinal Stenosis n = 53,043 and Degenerative Disc Disease n = 14,375). The proportion reaching the minimal important change (MIC) in Visual Analogue Scale for pain (VASBACK/LEG), Oswestry Disability Index (ODI) and the quality-of-life measure EQ-5DINDEX at 1 and 2 years, respectively, was calculated. The single-item questions such as Global Assessment (GABACK/LEG) and Satisfaction were analysed by the McNemar test. Threshold values for a successful outcome based on the final scores of each PROM at 1 and 2 years post-surgery were also defined.Results: For all the three diagnostic groups, the differences in proportions reaching MIC of each PROM at 1 and 2 years were below 2%. Global Assessment and Satisfaction with outcome at one year remained at 2 years. There were no important differences of threshold values of treatment success based on final scores CONCLUSION: No clinically important changes in PROMs appeared between 1 and 2 years after surgery for degenerative lumbar conditions, demonstrating that a follow-up period of 1 year as opposed to 2 years is sufficient in effectiveness studies if PROMs are to be used as outcome variables. These slides can be retrieved under Electronic Supplementary Material. [ABSTRACT FROM AUTHOR]

Purpose: There are two, principally different ways to obtain patient opinions regarding the outcome of spine surgery: using prospective multi-item questionnaires preoperatively and at follow-up, and using a retrospective single-item question at follow-up-both methods have distinct advantages and limitations. The purpose of the study was to explore the utility of using the simple transition question global assessment, GA, ("How is your back/leg pain today as compared to before the surgery?") as an overall patient-reported outcome measure (PROM) based on the large real-life database in the Swedish spine registry (Swespine).Methods: The correlation between GA and the score-changes and the final scores at 1 year of follow-up for the PROMs VAS, ODI, and EQ-5D was examined. The correlations between GA and item-specific domains within the ODI, EQ-5D and SF-36 as well as the discriminative ability of PROMs with GA as reference criterion were also analysed. The cohort consisted of 94,132 patients registered in Swespine who were surgically treated for disc herniation, spinal stenosis or degenerative disc disease.Results: The correlation coefficients for GA vs. the score-changes were lower than for GA vs final scores. For VAS they ranged for the different diagnosis groups from 0.33 to 0.61 and from 0.50 to 0.79, respectively. For ODI, the corresponding values ranged from 0.43 to 0.65 and 0.63 to 0.76; for the EQ-5D from 0.32 to 0.45 and 0.54 to 0.71. Further, GA showed a somewhat stronger correlation to pain-specific PROMs than to quality-of-life PROMs.Conclusions: The single-item outcome measure global assessment (GA) appears to be a feasible overall patient-reported outcome measure (PROM) and a useful reference for interpreting the scores of patient-reported outcome measures. [ABSTRACT FROM AUTHOR]