Characteristics and outcomes of patients who did not respond to a national spine surgery registry

Background Loss to follow-up may bias outcome assessments in medical registries. This cohort study aimed to analyze and compare patients who failed to respond with those that responded to the Norwegian Registry for Spine Surgery (NORspine). Methods We analyzed a cohort of 474 consecutive patients operated for lumbar spinal stenosis at four public hospitals in Norway during a two-year period. These patients reported sociodemographic data, preoperative symptoms, and Oswestry Disability Index (ODI), numerical rating scales (NRS) for back and leg pain to NORspine at baseline and 12 months postoperatively. We contacted all patients who did not respond to NORspine after 12 months. Those who responded were termed responsive non-respondents and compared to 12 months respondents. Results One hundred forty (30%) did not respond to NORspine 12 months after surgery and 123 were available for additional follow-up. Sixty-four of the 123 non-respondents (52%) responded to a cross-sectional survey done at a median of 50 (36–64) months after surgery. At baseline, non-respondents were younger 63 (SD 11.7) vs. 68 (SD 9.9) years (mean difference (95% CI) 4.7 years (2.6 to 6.7); p= <0.001) and more frequently smokers 41 (30%) vs. 70 (21%) RR (95%CI)=1.40 (1.01 to 1.95); p=0.044. There were no other relevant differences in other sociodemographic variables or preoperative symptoms. We found no differences in the effect of surgery on non-respondents vs. respondents (ODI (SD)=28.2 (19.9) vs. 25.2 (18.9), MD (95%CI)=3.0 ( -2.1 to 8.1); p=0.250). Conclusion We found that 30% of patients did not respond to NORspine at 12 months after spine surgery. Non-respondents were somewhat younger and smoked more frequently than respondents; however, there were no differences in patient-reported outcome measures. Our findings suggest that attrition bias in NORspine was random and due to non-modifable factors

Clinical outcomes and safety assessment in elderly patients undergoing decompressive laminectomy for lumbar spinal stenosis: a prospective study

<p>Abstract</p> <p>Background</p> <p>To assess safety, risk factors and clinical outcomes in elderly patients with spinal stenosis after decompressive laminectomy.</p> <p>Methods</p> <p>A prospective cohort of patients 70 years and older with spinal stenosis undergoing conventional laminectomy without fusion (n = 101) were consecutively enrolled from regular clinical practice and reassessed at 3 and 12 months. Primary outcome was change in health related quality of life measured (HRQL) with EuroQol-5 D (EQ-5D). Secondary outcomes were safety assessment, changes in Oswestry disability index (ODI), Visual Analogue Scale (EQ-VAS) score for self reported health, VAS score for leg and back pain and patient satisfaction. We used regression analyses to evaluate risk factors for less improvement.</p> <p>Results</p> <p>The mean EQ-5 D total score were 0.32, 0.63 and 0.60 at baseline, 3 months and 12 months respectively, and represents a statistically significant (P < 0.001) improvement. Effect size was > 0.8. Mean ODI score at baseline was 44.2, at 3 months 25.6 and at 27.9. This represents an improvement for all post-operative scores. A total of 18 (18.0%) complications were registered with 6 (6.0%) classified as major, including one perioperative death. Patients stating that the surgery had been beneficial at 3 months was 82 (89.1%) and at 12 months 73 (86.9%). The only predictor found was patients with longer duration of leg pain had less improvement in ODI (P < 0.001). Increased age or having complications did not predict a worse outcome in any of the outcome variables.</p> <p>Conclusions</p> <p>Properly selected patients of 70 years and older can expect a clinical meaningful improvement of HRQL, functional status and pain after open laminectomy without fusion. The treatment seems to be safe. However, patients with longstanding leg-pain prior to operation are less likely to improve one year after surgery.</p

Clinical outcomes after surgery for cervical radiculopathy performed in public and private hospitals : a nationwide relative effectiveness study

Aims - The number of patients undergoing surgery for degenerative cervical radiculopathy has increased. In many countries, public hospitals have limited capacity. This has resulted in long waiting times for elective treatment and a need for supplementary private healthcare. It is uncertain whether the management of patients and the outcome of treatment are equivalent in public and private hospitals. The aim of this study was to compare the management and patient-reported outcomes among patients who underwent surgery for degenerative cervical radiculopathy in public and private hospitals in Norway, and to assess whether the effectiveness of the treatment was equivalent. Methods - This was a comparative study using prospectively collected data from the Norwegian Registry for Spine Surgery. A total of 4,750 consecutive patients who underwent surgery for degenerative cervical radiculopathy and were followed for 12 months were included. Case-mix adjustment between those managed in public and private hospitals was performed using propensity score matching. The primary outcome measure was the change in the Neck Disability Index (NDI) between baseline and 12 months postoperatively. A mean difference in improvement of the NDI score between public and private hospitals of ≤ 15 points was considered equivalent. Secondary outcome measures were a numerical rating scale for neck and arm pain and the EuroQol five-dimension three-level health questionnaire. The duration of surgery, length of hospital stay, and complications were also recorded. Results - The mean improvement from baseline to 12 months postoperatively of patients who underwent surgery in public and private hospitals was equivalent, both in the unmatched cohort (mean NDI difference between groups 3.9 points (95% confidence interval (CI) 2.2 to 5.6); p Conclusion - The clinical effectiveness of surgery for degenerative cervical radiculopathy performed in public and private hospitals was equivalent 12 months after surgery

Anterior surgical treatment for cervical degenerative radiculopathy: a prediction model for non-success

Purpose By using data from the Norwegian Registry for Spine Surgery, we wanted to develop and validate prediction models for non-success in patients operated with anterior surgical techniques for cervical degenerative radiculopathy (CDR). Methods This is a multicentre longitudinal study of 2022 patients undergoing CDR surgery and followed for 12 months to fnd prognostic models for non-success in neck disability and arm pain using multivariable logistic regression analysis. Model performance was evaluated by area under the receiver operating characteristic curve (AUC) and a calibration test. Internal validation by bootstrapping re-sampling with 1000 repetitions was applied to correct for over-optimism. The clinical usefulness of the neck disability model was explored by developing a risk matrix for individual case examples. Results Thirty-eight percent of patients experienced non-success in neck disability and 35% in arm pain. Loss to follow-up was 35% for both groups. Predictors for non-success in neck disability were high physical demands in work, low level of education, pending litigation, previous neck surgery, long duration of arm pain, medium-to-high baseline disability score and presence of anxiety/depression. AUC was 0.78 (95% CI, 0.75, 0.82). For the arm pain model, all predictors for non-success in neck disability, except for anxiety/depression, were found to be signifcant in addition to foreign mother tongue, smoking and medium-to-high baseline arm pain. AUC was 0.68 (95% CI, 0.64, 0.72). Conclusion The neck disability model showed high discriminative performance, whereas the arm pain model was shown to be acceptable. Based upon the models, individualized risk estimates can be made and applied in shared decision-making with patients referred for surgical assessment

Prospects of returning to work after lumbar spine surgery for patients considering disability pension: A nationwide study based on data from the Norwegian Registry for Spine Surgery

Objectives To assess the odds for not returning to work (non-RTW) 1 year after treatment among patients who had applied for or were planning to apply for disability pension (DP-applicant) prior to an operation for degenerative disorders of the lumbar spine. Methods This population-based cohort study from the Norwegian Registry for Spine surgery included 26 688 cases operated for degenerative disorders of the lumbar spine from 2009 to 2020. The primary outcome was RTW (yes/no). Secondary patient-reported outcome measures (PROMs) were the Oswestry Disability Index, Numeric Rating Scales for back and leg pain, EuroQoL five-dimension and the Global Perceived Effect Scale. Logistic regression analysis was used to investigate associations between being a DP-applicant prior to surgery (exposure), possible confounders (modifiers) at baseline and RTW 12 months after surgery (outcome). Results The RTW ratio for DP-applicants was 23.1% (having applied: 26.5%, planning to apply 21.1%), compared with 78.6% among non-applicants. All secondary PROMs were more favourable among nonapplicants. After adjusting for all significant confounders (low expectations and pessimism related to working capability, not feeling wanted by the employer and physically demanding work), DP-applicants with under 12 months preoperative sick leave had 3.8 (95% CI 1.8 to 8.0) higher odds than non-applicants for non-RTW 12 months after surgery. The subgroup having applied for disability pension had the strongest impact on this association. Conclusion Less than a quarter of the DP-applicants returned to work 12 months after surgery. This association remained strong, also when adjusted for the confounders as well as other covariates related RTW

Return to Work after Surgery for Cervical Radiculopathy: A Nationwide Registry-based Observational Study

Study Design - An observational multicenter study. Summary of Background Data - Return to work (RTW) is increasingly used to assess the standard, benefit, and quality of health care. Objective - The aim of this study was to evaluate sick leave patterns among patients undergoing surgery for cervical radiculopathy and identify predictors of successful RTW using two nationwide databases. Materials and Methods - Data from the Norwegian Registry for Spine Surgery (NORspine) and the Norwegian Labour and Welfare Administration were linked on an individual level. We included patients between 18 and 60 years of age registered in NORspine from June 2012 through December 2019 that were temporarily out of the labor force for medical reasons at the time of surgery. We assessed types and grades of sickness benefits before and after surgery and conducted logistic regression analyses. Results - Among 3387 patients included in the study, 851 (25.1%) received temporary benefits one year before surgery. The proportion of recipients increased steadily towards surgery. Postoperatively the medical benefit payment decreased rapidly, and half of the patients had already returned to work by four months. The rate of RTW reached a plateau at one year. By the end of the third year, 2429 patients (71.7%) had returned to work. The number of sick days, categorized as 90 or less, during the year before surgery had the most powerful association with RTW at two years (odds ratio: 4.54, 95% CI: 3.42–6.03, P Conclusion - RTW after cervical radiculopathy surgery occurs primarily during the first year. The strongest predictor of RTW was fewer sick days before surgery. The clinical improvement after surgery had a lesser impact

A nationwide study of patients operated for cervical degenerative disorders in public and private hospitals

During the last decades, there has been an increase in the rate of surgery for degenerative disorders of the cervical spine and in the use of supplementary private health insurance. Still, there is limited knowledge about the diferences in characteristics of patients operated in public and private hospitals. Therefore, we aimed at comparing sociodemographic-, clinical- and patient management data on patients operated for degenerative cervical radiculopathy and degenerative cervical myelopathy in public and private hospitals in Norway. This was a cross-sectional study on patients in the Norwegian Registry for Spine Surgery operated for degenerative cervical radiculopathy and degenerative cervical myelopathy between January 2012 and December 2020. At admission for surgery, we assessed disability by the following patient reported outcome measures (PROMs): neck disability index (NDI), EuroQol-5D (EQ-5D) and numerical rating scales for neck pain (NRS-NP) and arm pain (NRS-AP). Among 9161 patients, 7344 (80.2%) procedures were performed in public hospitals and 1817 (19.8%) in private hospitals. Mean age was 52.1 years in public hospitals and 49.7 years in private hospitals (P< 0.001). More women were operated in public hospitals (47.9%) than in private hospitals (31.6%) (P< 0.001). A larger proportion of patients in private hospitals had high education (≥4 years of college or university) (42.9% vs 35.6%, P< 0.001). Patients in public hospitals had worse disease-specifc health problems than those in private hospitals: unadjusted NDI mean diference was 5.2 (95% CI 4.4 – 6.0; P< 0.001) and adjusted NDI mean diference was 3.4 (95% CI 2.5 – 4.2; P< 0.001), and they also had longer duration of symptoms (P< 0.001). Duration of surgery (mean diference 29 minutes, 95% CI 27.1 – 30.7; P< 0.001) and length of hospital stay (mean diference 2 days, 95% CI 2.3 – 2.4; P< 0.001) were longer in public hospitals. In conclusion, patients operated for degenerative cervical spine in private hospitals were healthier, younger, better educated and more often men. They also had less and shorter duration of symptoms and seemed to be managed more efciently. Our fndings indicate that access to cervical spine surgery in private hospitals could be skewed in favour of patients with higher socioeconomic status

Non-respondents do not bias outcome assessment after cervical spine surgery: a multicenter observational study from the Norwegian registry for spine surgery (NORspine)

Background - The Norwegian registry for spine surgery (NORspine) is a national clinical quality registry which has recorded more than 10,000 operations for degenerative conditions of the cervical spine since 2012. Registries are large observational cohorts, at risk for attrition bias. We therefore aimed to examine whether clinical outcomes differed between respondents and non-respondents to standardized questionnaire-based 12-month follow-up. Methods - All eight public and private providers of cervical spine surgery in Norway report to NORspine. We included 334 consecutive patients who were registered with surgical treatment of degenerative conditions in the cervical spine in 2018 and did a retrospective analysis of prospectively collected register data and data on non-respondents’ outcomes collected by telephone interviews. The primary outcome measure was patient-reported change in arm pain assessed with the numeric rating scale (NRS). Secondary outcome measures were change in neck pain assessed with the NRS, change in health-related quality of life assessed with EuroQol 5 Dimensions (EQ-5D), and patients’ perceived benefit of the operation assessed by the Global Perceived Effect (GPE) scale. Results - At baseline, there were few and small differences between the 238 (71.3%) respondents and the 96 (28.7%) non-respondents. We reached 76 (79.2%) non-respondents by telephone, and 63 (65.6%) consented to an interview. There was no statistically significant difference between groups in change in NRS score for arm pain (3.26 (95% CI 2.84 to 3.69) points for respondents and 2.77 (1.92 to 3.63) points for telephone interviewees) or any of the secondary outcome measures. Conclusions - The results indicate that patients lost to follow-up were missing at random. Analyses of outcomes based on data from respondents can be considered representative for the complete register cohort, if patient characteristics associated with attrition are controlled for

The Risk of Getting Worse: Predictors of Deterioration After Decompressive Surgery for Lumbar Spinal Stenosis: A Multicenter Observational Study

ObjectiveTo investigate the frequency and predictors of deterioration after decompressive surgery for single and 2-level lumbar spinal stenosis.MethodsProspectively collected data were retrieved from the Norwegian Registry for Spine Surgery. Clinically significant deterioration was defined as an 8-point increase in Oswestry disability index (ODI) between baseline and 12 months' follow-up.ResultsThere were 2181 patients enrolled in the study. Of 1735 patients with complete 12 months follow-up, 151 (8.7%) patients reported deterioration. The following variables were significantly associated with deterioration at 12 months' follow-up; decreasing age (odds ratio [OR] 1.02, 95% confidence interval [95% CI] 1.00–1.04, P = 0.046), tobacco smoking (OR 2.10, 95% CI 1.42–3.22, P = 0.000), American Society of Anesthesiologists grade ≥3 (OR 1.80, 95% CI 1.07–2.94, P = 0.025), decreasing preoperative ODI (OR 1.05, 95% CI 1.02–1.07, P = 0.000), previous surgery at the same level (OR 2.00, 95% CI 1.18–3.27, P = 0.009), and previous surgery at other lumbar levels (OR 2.10, 95% CI 1.19–3.53, P = 0.009).ConclusionsOverall risk of clinically significant deterioration in patient-reported pain and disability after decompressive surgery for lumbar spinal stenosis is approximately 9%. Predictors for deterioration are decreasing age, current tobacco smoking, American Society of Anesthesiologists grade ≥3, decreasing preoperative ODI, and previous surgery at same or different lumbar level. We suggest that these predictors should be emphasized and discussed with the patients before surgery