Patient Characteristics Associated With Worsening of Neck Pain-Related Disability After Surgery for Degenerative Cervical Myelopathy: A Nationwide Study of 1508 Patients.

BACKGROUND AND OBJECTIVES: Functional status, pain, and quality of life usually improve after surgery for degenerative cervical myelopathy (DCM), but a subset of patients report worsening. The objective was to define cutoff values for worsening on the Neck Disability Index (NDI) and identify prognostic factors associated with worsening of pain-related disability 12 months after DCM surgery. METHODS: In this prognostic study based on prospectively collected data from the Norwegian Registry for Spine Surgery, the NDI was the primary outcome. Receiver operating characteristics curve analyses were used to obtain cutoff values, using the global perceived effect scale as an external anchor. Univariable and multivariable analyses were performed using mixed logistic regression to evaluate the relationship between potential prognostic factors and the NDI. RESULTS: Among the 1508 patients undergoing surgery for myelopathy, 1248 (82.7%) were followed for either 3 or 12 months. Of these, 317 (25.4%) were classified to belong to the worsening group according to the mean NDI percentage change cutoff of 3.3. Multivariable analyses showed that smoking (odds ratio [OR] 3.4: 95% CI 1.2-9.5: P < .001), low educational level (OR 2.5: 95% CI 1.0-6.5: P < .001), and American Society of Anesthesiologists grade >II (OR 2.2: 95% CI 0.7-5.6: P = .004) were associated with worsening. Patients with more severe neck pain (OR 0.8: 95% CI 0.7-1.0: P = .003) and arm pain (OR 0.8: 95% CI 0.7-1.0; P = .007) at baseline were less likely to report worsening. CONCLUSION: We defined a cutoff value of 3.3 for worsening after DCM surgery using the mean NDI percentage change. The independent prognostic factors associated with worsening of pain-related disability were smoking, low educational level, and American Society of Anesthesiologists grade >II. Patients with more severe neck and arm pain at baseline were less likely to report worsening at 12 months.

Long-Term Results After Surgery for Degenerative Cervical Myelopathy.

BACKGROUND AND OBJECTIVES: Degenerative cervical myelopathy (DCM) is a frequent cause of spinal cord dysfunction, and surgical treatment is considered safe and effective. Long-term results after surgery are limited. This study investigated long-term clinical outcomes through data from the Norwegian registry for spine surgery. METHODS: Patients operated at the university hospitals serving Central and Northern Norway were approached for long-term follow-up after 3 to 8 years. The primary outcome was change in the Neck Disability Index, and the secondary outcomes were changes in the European Myelopathy Scale score, quality of life (EuroQoL EQ-5D); numeric rating scales (NRS) for headache, neck pain, and arm pain; and perceived benefit of surgery assessed by the Global Perceived Effect scale from 1 year to long-term follow-up. RESULTS: We included 144 patients operated between January 2013 and June 2018. In total, 123 participants (85.4%) provided patient-reported outcome measures (PROMs) at long-term follow-up. There was no significant change in PROMs from 1 year to long-term follow-up, including Neck Disability Index (mean 1.0, 95% CI -2.1-4.1, P = .53), European Myelopathy Scale score (mean -0.3, 95% CI -0.7-0.1, P = .09), EQ-5D index score (mean -0.02, 95% CI -0.09-0.05, P = .51), NRS neck pain (mean 0.3 95% CI -0.2-0.9, P = .22), NRS arm pain (mean -0.1, 95% CI -0.8-0.5, P = .70), and NRS headache (mean 0.4, 95% CI -0.1-0.9, P = .11). According to Global Perceived Effect assessments, 106/121 patients (87.6%) reported to be stable or improved ("complete recovery," "much better," "slightly better," or "unchanged") at long-term follow-up compared with 88.1% at 1 year. Dichotomizing the outcome data based on severity of DCM did not demonstrate significant changes either. CONCLUSION: Long-term follow-up of patients undergoing surgery for DCM demonstrates persistence of statistically significant and clinically meaningful improvement across a wide range of PROMs.

The Norwegian registry for spine surgery (NORspine): cohort profile.

PURPOSE: To review and describe the development, methods and cohort of the lumbosacral part of the Norwegian registry for spine surgery (NORspine). METHODS: NORspine was established in 2007. It is government funded, covers all providers and captures consecutive cases undergoing operations for degenerative disorders. Patients' participation is voluntary and requires informed consent. A set of baseline-, process- and outcome-variables (3 and 12 months) recommended by the International Consortium for Health Outcome Measurement is reported by surgeons and patients. The main outcome is the Oswestry disability index (ODI) at 12 months. RESULTS: We show satisfactory data quality assessed by completeness, timeliness, accuracy, relevance and comparability. The coverage rate has been 100% since 2016 and the capture rate has increased to 74% in 2021. The cohort consists of 60,647 (47.6% women) cases with mean age 55.7 years, registered during the years 2007 through 2021. The proportions > 70 years and with an American Society of Anaesthesiologists' Physical Classification System (ASA) score > II has increased gradually to 26.1% and 19.3%, respectively. Mean ODI at baseline was 43.0 (standard deviation 17.3). Most cases were operated with decompression for disc herniation (n = 26,557, 43.8%) or spinal stenosis (n = 26,545, 43.8%), and 7417 (12.2%) with additional or primary fusion. The response rate at 12 months follow-up was 71.6%. CONCLUSION: NORspine is a well-designed population-based comprehensive national clinical quality registry. The register's methods ensure appropriate data for quality surveillance and improvement, and research.

Persistent Use of Prescription Opioids Before and After Lumbar Spine Surgery: Observational Study With Prospectively Collected Data From Two Norwegian National Registries.

STUDY DESIGN: Prospective pharmacoepidemiologic study. OBJECTIVE: To investigate clinical and sociodemographic factors associated with persistent opioid use in the years following spine surgery among patients with persistent opioid use preceding lumbar spine surgery. SUMMARY OF BACKGROUND DATA: It is unknown whether successful spine surgery leads to a cessation of preoperative persistent opioid use. MATERIALS AND METHODS: Data from the Norwegian Registry for Spine Surgery and the Norwegian Prescription Database were linked for patients operated for degenerative lumbar spine disorders between 2007 and 2017. The primary outcome measure was persistent opioid use in the second year after surgery. Functional disability was measured with the Oswestry Disability Index (ODI). Factors associated with persistent opioid use in the year before, and two years following, surgery were identified using multivariable logistic regression analysis. The variables included in the analysis were selected based on their demonstrated role in prior studies. RESULTS: The prevalence of persistent opioid use was 8.7% in the year before surgery. Approximately two-thirds of patients also met the criteria for persistent opioid use the second year after surgery. Among patients who did not meet the criteria for persistent opioid use the year before surgery, 991 (3.3%) patients developed persistent opioid use in the second year following surgery. The strongest association was exhibited by high doses of benzodiazepines in the year preceding surgery (OR 1.7, 95% CI 1.26 to 2.19, P <0.001). Among patients without persistent opioid use, the most influential factor associated with new-onset persistent opioid use in the second year after surgery was the use of high doses of benzodiazepines (OR 1.8, 95% CI 1.26 to 2.44, P <0.001), high doses of z -hypnotics (OR 2.6, 95% CI 2.10 to 3.23, P <0.001) and previous surgery at the same lumbar level (OR 1.37, 95% CI 1.11 to 1.68, P =0.003). CONCLUSION: A substantial proportion of patients reported sustained opioid use after surgery. Patients with persistent opioid use before surgery should be supported to taper off opioid treatment. Special efforts appear to be required to taper off opioid use in patients using high doses of benzodiazepines. LEVEL OF EVIDENCE: 2; Prospective observational study.

Impact of the number of previous lumbar operations on patient-reported outcomes after surgery for lumbar spinal stenosis or lumbar disc herniation.

Repeated lumbar spine surgery has been associated with inferior clinical outcomes. This study aimed to examine and quantify the impact of this association in a national clinical register cohort. This is a population-based study from the Norwegian Registry for Spine surgery (NORspine). We included 26,723 consecutive cases operated for lumbar spinal stenosis or lumbar disc herniation from January 2007 to December 2018. The primary outcome was the Oswestry Disability Index (ODI), presented as the proportions reaching a patient-acceptable symptom state (PASS; defined as an ODI raw score ≤ 22) and ODI raw and change scores at 12-month follow-up. Secondary outcomes were the Global Perceived Effect scale, the numerical rating scale for pain, the EuroQoL five-dimensions health questionnaire, occurrence of perioperative complications and wound infections, and working capability. Binary logistic regression analysis was conducted to examine how the number of previous operations influenced the odds of not reaching a PASS. The proportion reaching a PASS decreased from 66.0% (95% confidence interval (CI) 65.4 to 66.7) in cases with no previous operation to 22.0% (95% CI 15.2 to 30.3) in cases with four or more previous operations (p < 0.001). The odds of not reaching a PASS were 2.1 (95% CI 1.9 to 2.2) in cases with one previous operation, 2.6 (95% CI 2.3 to 3.0) in cases with two, 4.4 (95% CI 3.4 to 5.5) in cases with three, and 6.9 (95% CI 4.5 to 10.5) in cases with four or more previous operations. The ODI raw and change scores and the secondary outcomes showed similar trends. We found a dose-response relationship between increasing number of previous operations and inferior outcomes among patients operated for degenerative conditions in the lumbar spine. This information should be considered in the shared decision-making process prior to elective spine surgery.

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 < 0.001) and in the matched cohort (4.0 points (95% CI 2.3 to 5.7); p < 0.001). Secondary outcomes showed similar results. The duration of surgery and length of hospital stay were significantly longer in public hospitals. Those treated in private hospitals reported significantly fewer complications in the unmatched cohort, but not in the matched cohort. CONCLUSION: The clinical effectiveness of surgery for degenerative cervical radiculopathy performed in public and private hospitals was equivalent 12 months after surgery.Cite this article: Bone Joint J 2023;105-B(1):64-71.

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.

Surgery for degenerative cervical myelopathy in patients with rheumatoid arthritis and ankylosing spondylitis: a nationwide registry-based study with patient-reported outcomes.

PURPOSE: To compare patient-reported outcomes (PROMs) following surgery for degenerative cervical myelopathy (DCM) among patients with rheumatoid arthritis (RA) or ankylosing spondylitis (AS) versus those without rheumatic diseases. METHODS: Data were obtained from the Norwegian Registry for Spine Surgery. The primary outcome was change in the Neck Disability Index (NDI) at 1 year. Secondary endpoints included the European Myelopathy Score (EMS), quality of life (EuroQoL-5D [EQ-5D]), numeric rating scales (NRS) for headache, neck pain, and arm pain, and complications. RESULTS: Among 905 participants operated between 2012 and 2018, 35 had RA or AS. There were significant improvements in all PROMs at 1 year and no statistically significant difference between the cohorts in mean change in NDI (- 0.64, 95% CI - 8.1 to 6.8, P = .372), EQ-5D (0.10, 95% CI - 0.04 to 0.24, P = .168), NRS neck pain (- 0.8, 95% CI - 2.0 to 0.4, P = .210), NRS arm pain (- 0.6, 95% CI - 1.9 to 0.7, P = .351), and NRS headache (- 0.5, 95% CI - 1.7 to 0.8, P = .460). DISCUSSION AND CONCLUSION: Our study adds to the limited available evidence that surgical treatment cannot only arrest further progression of myelopathy but also improve functional status, neurological outcomes, and quality of life in patients with rheumatic disease.

Effect of Spinal Cord Burst Stimulation vs Placebo Stimulation on Disability in Patients With Chronic Radicular Pain After Lumbar Spine Surgery: A Randomized Clinical Trial.

Importance: The use of spinal cord stimulation for chronic pain after lumbar spine surgery is increasing, yet rigorous evidence of its efficacy is lacking. Objective: To investigate the efficacy of spinal cord burst stimulation, which involves the placement of an implantable pulse generator connected to electrodes with leads that travel into the epidural space posterior to the spinal cord dorsal columns, in patients with chronic radiculopathy after surgery for degenerative lumbar spine disorders. Design, Setting, and Participants: This placebo-controlled, crossover, randomized clinical trial in 50 patients was conducted at St Olavs University Hospital in Norway, with study enrollment from September 5, 2018, through April 28, 2021. The date of final follow-up was May 20, 2022. Interventions: Patients underwent two 3-month periods with spinal cord burst stimulation and two 3-month periods with placebo stimulation in a randomized order. Burst stimulation consisted of closely spaced, high-frequency electrical stimuli delivered to the spinal cord. The stimulus consisted of a 40-Hz burst mode of constant-current stimuli with 4 spikes per burst and an amplitude corresponding to 50% to 70% of the paresthesia perception threshold. Main Outcomes and Measures: The primary outcome was difference in change from baseline in the self-reported Oswestry Disability Index (ODI; range, 0 points [no disability] to 100 points [maximum disability]; the minimal clinically important difference was 10 points) score between periods with burst stimulation and placebo stimulation. The secondary outcomes were leg and back pain, quality of life, physical activity levels, and adverse events. Results: Among 50 patients who were randomized (mean age, 52.2 [SD, 9.9] years; 27 [54%] were women), 47 (94%) had at least 1 follow-up ODI score and 42 (84%) completed all stimulation randomization periods and ODI measurements. The mean ODI score at baseline was 44.7 points and the mean changes in ODI score were -10.6 points for the burst stimulation periods and -9.3 points for the placebo stimulation periods, resulting in a mean between-group difference of -1.3 points (95% CI, -3.9 to 1.3 points; P = .32). None of the prespecified secondary outcomes showed a significant difference. Nine patients (18%) experienced adverse events, including 4 (8%) who required surgical revision of the implanted system. Conclusions and Relevance: Among patients with chronic radicular pain after lumbar spine surgery, spinal cord burst stimulation, compared with placebo stimulation, after placement of a spinal cord stimulator resulted in no significant difference in the change from baseline in self-reported back pain-related disability. Trial Registration: ClinicalTrials.gov Identifier: NCT03546738.

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 differences 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-specific health problems than those in private hospitals: unadjusted NDI mean difference was 5.2 (95% CI 4.4 - 6.0; P < 0.001) and adjusted NDI mean difference 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 difference 29 minutes, 95% CI 27.1 - 30.7; P < 0.001) and length of hospital stay (mean difference 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 efficiently. Our findings indicate that access to cervical spine surgery in private hospitals could be skewed in favour of patients with higher socioeconomic status.

Surgery for degenerative cervical myelopathy in the elderly: a nationwide registry-based observational study with patient-reported outcomes.

BACKGROUND: The aim of this study was to investigate whether clinical outcomes in patients aged ≥ 70 undergoing decompressive surgery for degenerative cervical myelopathy (DCM) differ from those of younger patients (50-70 years) at 1 year. METHODS: Data were obtained from the Norwegian Registry for Spine Surgery (NORspine). Among 651 patients included, 177 (27.2%) were ≥ 70 years old. The primary outcome was change in the Neck Disability Index (NDI). Secondary outcomes were changes in the European Myelopathy Score (EMS), quality of life (EuroQoL EQ-5D), numeric rating scales (NRS) for headache, neck pain, and arm pain, and complications. RESULTS: Significant improvements in all patient-reported outcomes (PROMs) were detected for both age cohorts at 1 year. For the two age cohorts combined, there was a statistically significant improvement in the NDI score (mean 9.2, 95% CI 7.7 to 10.6, P < 0.001). There were no differences between age cohorts in mean change of NDI (- 8.9 vs. - 10.1, P = 0.48), EQ-5D (0.13 vs. 0.17, P = 0.37), or NRS pain scores, but elderly patients experienced a larger improvement in EMS (0.7 vs. 1.3, P = 0.02). A total of 74 patients (15.6%) in the younger cohort and 43 patients (24.3%) in the older cohort experienced complications or adverse effects within 3 months of surgery, mainly urinary and respiratory tract infections. CONCLUSION: Surgery for DCM was associated with significant improvement across a wide range of PROMs for both younger and elderly patients. Surgery for DCM should not be denied based on age alone.

Persistent Use of Prescription Opioids Following Lumbar Spine Surgery: Observational Study with Prospectively Collected Data From Two Norwegian Nationwide Registries.

STUDY DESIGN: Prospective pharmacoepidemiological study. OBJECTIVE: To investigate the use of prescription opioids 2 years following degenerative lumbar spine surgery. SUMMARY OF BACKGROUND DATA: There are limited data providing details to evaluate patterns of opioid use. The number of patients is often limited and data on opioid use following some of the most common surgical procedures are lacking. METHODS: Data from the Norwegian Registry for Spine Surgery and the Norwegian Prescription Database were linked on an individual level. The primary outcome measure was persistent opioid use the second year after surgery. Functional disabilitywas measured with the Oswestry disability index (ODI). Study participants were operated between 2007 and 2017. RESULTS: Among 32,886 study participants, 2754 (8.4%) met criteria for persistent opioid use the second year after surgery. Among persistent opioid users in the second year after surgery, 64% met the criteria for persistent opioid use the year preceding surgery. Persistent opioid use the year preceding surgery (odds ratio [OR] 31.10, 95% confidence interval [CI] 26.9-36.0, P  = 0.001), use of high doses of benzodiazepines (OR 1.62, 95% CI 1.30-2.04, P  = 0.001), and use of high doses of z-hypnotics (OR 1.90, 95% CI 1.58-2.22, P  = 0.001) the year before surgery were associated with increased risk of persistent opioid use the second year after surgery. A higher ODI score at 1 year was observed in persistent opioid users compared with non-persistent users (41.5 vs. 18.8 points) and there was a significant difference in ODI change (-13.7 points). Patients with persistent opioid use in the year preceding surgery were less likely to achieve a minimal clinically important ODI change at 1 year compared with non-persistent users (37.7% vs. 52.6%, P  = 0.001). CONCLUSION: Patients with or at risk of developing persistent opioid should be identified and provided counseling and support to taper off opioid treatment.Level of Evidence: 2.

Pain During Sex Before and After Decompressive Surgery for Lumbar Spinal Stenosis: A Multicenter Observational Study.

STUDY DESIGN: Observational multicenter study. OBJECTIVE: The aim of this study was to evaluate changes in pain during sexual activity after surgery for lumbar spinal stenosis (LSS). SUMMARY OF BACKGROUND DATA: There are limited data available on sexual function in patients undergoing surgery for LSS. METHODS: Data were retrieved from the Norwegian Registry for Spine Surgery. The primary outcome was change in pain during sexual activity at 1 year, assessed by item number eight of the Oswestry disability index questionnaire. Secondary outcome measures included Oswestry Disability Index, EuroQol-5D, and numeric rating scale scores for back and leg pain. RESULTS: Among the 12,954 patients included, 9908 (76.5%) completed 1-year follow-up. At baseline 9579 patients (73.9%) provided information about pain during sexual activity, whereas 7424 (74.9%) among those with complete follow-up completed this item. Preoperatively 2528 of 9579 patients (26.4%) reported a normal sex-life without pain compared with 4294 of 7424 patients (57.8%) at 1 year. Preoperatively 1007 (10.5%) patients reported that pain prevented any sex-life, compared with 393 patients (5.3%) at 1 year. At baseline 7051 of 9579 patients (73.6%) reported that sexual activity caused pain, and among these 3145 of 4768 responders (66%) reported an improvement at 1 year. A multivariable regression analysis showed that having a life partner, college education, and working until time of surgery were predictors of improvement in pain during sexual activity. Current tobacco smoking, pain duration >12 months, previous spine surgery, and complications occurring within 3 months were negative predictors. CONCLUSION: This study clearly demonstrates that a large proportion of patients undergoing surgery for LSS experienced an improvement in pain during sexual activity at 1 year.Level of Evidence: 2.

A prognostic model for failure and worsening after lumbar microdiscectomy: a multicenter study from the Norwegian Registry for Spine Surgery.

OBJECTIVE: To develop a prognostic model for failure and worsening 1 year after surgery for lumbar disc herniation. METHODS: This multicenter cohort study included 11,081 patients operated with lumbar microdiscectomy, registered at the Norwegian Registry for Spine Surgery. Follow-up was 1 year. Uni- and multivariate logistic regression analyses were used to assess potential prognostic factors for previously defined cut-offs for failure and worsening on the Oswestry Disability Index scores 12 months after surgery. Since the cut-offs for failure and worsening are different for patients with low, moderate, and high baseline ODI scores, the multivariate analyses were run separately for these subgroups. Data were split into a training (70%) and a validation set (30%). The model was developed in the training set and tested in the validation set. A prediction (%) of an outcome was calculated for each patient in a risk matrix. RESULTS: The prognostic model produced six risk matrices based on three baseline ODI ranges (low, medium, and high) and two outcomes (failure and worsening), each containing 7 to 11 prognostic factors. Model discrimination and calibration were acceptable. The estimated preoperative probabilities ranged from 3 to 94% for failure and from 1 to 72% for worsening in our validation cohort. CONCLUSION: We developed a prognostic model for failure and worsening 12 months after surgery for lumbar disc herniation. The model showed acceptable calibration and discrimination, and could be useful in assisting physicians and patients in clinical decision-making process prior to surgery.

Surgery for Degenerative Cervical Myelopathy: A Nationwide Registry-Based Observational Study With Patient-Reported Outcomes.

BACKGROUND: Indications and optimal timing for surgical treatment of degenerative cervical myelopathy (DCM) remain unclear, and data from daily clinical practice are warranted. OBJECTIVE: To investigate clinical outcomes following decompressive surgery for DCM. METHODS: Data were obtained from the Norwegian Registry for Spine Surgery. The primary outcome was change in the neck disability index (NDI) 1 yr after surgery. Secondary endpoints were the European myelopathy score (EMS), quality of life (EuroQoL 5D [EQ-5D]), numeric rating scales (NRS) for headache, neck pain, and arm pain, complications, and perceived benefit of surgery assessed by the Global Perceived Effect (GPE) scale. RESULTS: We included 905 patients operated between January 2012 and June 2018. There were significant improvements in all patient-reported outcome measures (PROMs) including NDI (mean -10.0, 95% CI -11.5 to -8.4, P < .001), EMS (mean 1.0, 95% CI 0.8-1.1, P < .001), EQ-5D index score (mean 0.16, 95% CI 0.13-0.19, P < .001), EQ-5D visual analogue scale (mean 13.8, 95% CI 11.7-15.9, P < .001), headache NRS (mean -1.1, 95% CI -1.4 to -0.8, P < .001), neck pain NRS (mean -1.8, 95% CI -2.0 to -1.5, P < .001), and arm pain NRS (mean -1.7, 95% CI -1.9 to -1.4, P < .001). According to GPE scale assessments, 229/513 patients (44.6%) experienced "complete recovery" or felt "much better" at 1 yr. There were significant improvements in all PROMs for both mild and moderate-to-severe DCM. A total of 251 patients (27.7%) experienced adverse effects within 3 mo. CONCLUSION: Surgery for DCM is associated with significant and clinically meaningful improvement across a wide range of PROMs.

Validation of the Nepali versions of the Neck Disability Index and the Numerical Rating Scale for Neck Pain.

STUDY DESIGN: A cross-sectional study with a test-retest design. OBJECTIVE: To translate and culturally adapt the numerical rating scale (NRS) for neck pain intensity and the Neck Disability Index (NDI), and asses their measurement properties in a Nepalese neck pain population. SUMMARY OF BACKGROUND DATA: Neck pain is one of the most common musculoskeletal disorders in Nepal. Research on neck pain disorders has been hampered by lack of standardized patient-reported outcome measures (PROMs) in Nepali language. Therefore, we aimed at validating a Nepali version of the NDI and NRS neck pain. METHODS: At Dhulikhel hospital in Nepal, 150 patients with neck pain and/or cervical radiculopathy completed the translated self-administered questionnaires. We had made one cultural adaption of the NDI driving item in the final Nepali version. Relative reliability was analyzed with intraclass correlation coefficient (ICC 2.1) and absolute reliability with the smallest detectable change (SDC). Internal consistency was assessed by Cronbach alpha. Construct and discriminative validity was assessed by Spearman correlation for a priori hypotheses, receiver-operating characteristics curves, and analysis of variance. Time spent and assistance needed to complete the questionnaires were used to assess feasibility. RESULTS: Test-restest reliability was excellent with ICC (95% confidence intervals) of 0.87 (0.66, 0.94) for NDI and 0.97 (0.94, 0.99) for NRS neck pain. The absolute reliability was acceptable (a SDC of 1.6 for NRS and 9.3 for NDI) and a Cronbach alpha (internal consistency) of 0.70 for NDI, as well as acceptable construct validity, discriminative validity, and feasibility. CONCLUSION: The Nepali versions of the NRS neck pain and NDI can be recommended for assessing pain and disability among patients with neck pain and cervical radiculopathy, but their responsiveness to change remains to be tested.Level of Evidence: 2.

Pain During Sex Before and After Surgery for Lumbar Disc Herniation: A Multicenter Observational Study.

STUDY DESIGN: Observational multicenter study. OBJECTIVE: The aim of this study was to evaluate changes in pain during sexual activity after surgery for lumbar disc herniation (LDH). SUMMARY OF BACKGROUND DATA: There are limited data available on sexual function in patients undergoing surgery for LDH. METHODS: Data were retrieved from the Norwegian Registry for Spine Surgery. The primary outcome was change in pain during sexual activity at one year, assessed by item number eight of the Oswestry disability index (ODI) questionnaire. Secondary outcome measures included ODI, EuroQol-5D (EQ-5D), and numeric rating scale (NRS) scores for back and leg pain. RESULTS: Among the 18,529 patients included, 12,103 (64.8%) completed 1-year follow-up. At baseline, 16,729 patients (90.3%) provided information about pain during sexual activity, whereas 11,130 (92.0%) among those with complete follow-up completed this item. Preoperatively 2586 of 16,729 patients (15.5%) reported that pain did not affect sexual activity and at 1 year, 7251 of 11,130 patients (65.1%) reported a normal sex-life without pain. Preoperatively, 2483 (14.8%) patients reported that pain prevented any sex-life, compared to 190 patients (1.7%) at 1 year. At baseline, 14,143 of 16,729 patients (84.5%) reported that sexual activity caused pain, and among these 7232 of 10,509 responders (68.8%) reported an improvement at 1 year. A multivariable regression analysis showed that having a life partner, college education, working until time of surgery, undergoing emergency surgery, and increasing ODI score were predictors of improvement in pain during sexual activity. Increasing age, tobacco smoking, increasing body mass index, comorbidity, back pain >12 months, previous spine surgery, surgery in two or more lumbar levels, and complications occurring within 3 months were negative predictors. CONCLUSION: This study clearly demonstrates that a large proportion of patients undergoing surgery for LDH experienced an improvement in pain during sexual activity at 1 year. LEVEL OF EVIDENCE: 2.

Microdiscectomy for Lumbar Disc Herniation: A Single-Center Observational Study.

OBJECTIVE: To examine outcomes and complications following first-time lumbar microdiscectomy. METHODS: Prospective data for patients operated on between May 2007 and July 2016 were obtained from the Norwegian Registry for Spine Surgery. The primary outcome was change in Oswestry Disability Index (ODI) score at 1 year. Secondary endpoints were change in quality of life measured with EuroQol 5 Dimensions, back and leg pain measured with numeric rating scales, and perioperative complications within 3 months of surgery. RESULTS: For all enrolled patients (N = 1219) enrolled, mean improvement in ODI at 1 year was 33.3 points (95% confidence interval [CI] 31.7 to 34.9, P < 0.001). Mean improvement in EuroQol 5 Dimensions at 1 year of 0.52 point (95% CI 0.49 to 0.55, P < 0.001) represents a large effect size (Cohen's d = 1.6). Mean improvements in back pain and leg pain numeric rating scales were 3.9 points (95% CI 3.6 to 4.1, P < 0.001) and 5.0 points (95% CI 4.8 to 5.2, P < 0.001), respectively. There were 18 surgical complications in 1219 patients and 63 medical complications in 846 patients. The most common complication was micturition problems at 3 months following surgery (n = 25, 2.1%). In multivariate analysis, ODI scores of 21-40 (hazard ratio [HR] 14.5, 95% CI 1.1 to 27.9, P = 0.035), 41-60 (HR 27.5, 95% CI 13.4 to 41.7, P < 0.001), 61-80 (HR 47.4, 95% CI 33.4 to 61.4, P < 0.001) and >81 (HR 66.7, 95% CI 51.1 to 82.2, P < 0.001) were identified as positive predictors for ODI improvement at 1 year, whereas age ≥65 (HR -0.9, 95% CI -0.3 to -1.5, P = 0.004) was identified as a negative predictor for ODI improvement. CONCLUSIONS: Microdiscectomy for lumbar disc herniation is an effective and safe treatment.

Surgery for herniated lumbar disc in private vs public hospitals: A pragmatic comparative effectiveness study.

BACKGROUND: There is limited evidence on the comparative performance of private and public healthcare. Our aim was to compare outcomes following surgery for lumbar disc herniation (LDH) in private versus public hospitals. METHODS: Data were obtained from the Norwegian registry for spine surgery. Primary outcome was change in Oswestry disability index (ODI) 1 year after surgery. Secondary endpoints were quality of life (EuroQol EQ-5D), back and leg pain, complications, and duration of surgery and hospital stays. RESULTS: Among 5221 patients, 1728 in the private group and 3493 in the public group, 3624 (69.4%) completed 1-year follow-up. In the private group, mean improvement in ODI was 28.8 points vs 32.3 points in the public group (mean difference - 3.5, 95% CI - 5.0 to - 1.9; P for equivalence < 0.001). Equivalence was confirmed in a propensity-matched cohort and following mixed linear model analyses. There were differences in mean change between the groups for EQ-5D (mean difference - 0.05, 95% CI - 0.08 to - 0.02; P = 0.002) and back pain (mean difference - 0.2, 95% CI - 0.2, - 0.4 to - 0.004; P = 0.046), but after propensity matching, the groups did not differ. No difference was found between the two groups for leg pain. Complication rates was lower in the private group (4.5% vs 7.2%; P < 0.001), but after propensity matching, there was no difference. Patients operated in private clinics had shorter duration of surgery (48.4 vs 61.8 min) and hospital stay (0.7 vs 2.2 days). CONCLUSION: At 1 year, the effectiveness of surgery for LDH was equivalent in private and public hospitals.