Tore Solberg

Prophylactic hyperdynamic postoperative fluid therapy after aneurysmal subarachnoid hemorrhage: a clinical, prospective, randomized, controlled study.

OBJECTIVETo investigate the role of prophylactic hyperdynamic postoperative fluid therapy in preventing delayed ischemic neurological deficits attributable to cerebral vasospasm. METHODSWe designed a prospected, randomized, controlled study and included 32 patients with subarachnoid hemorrhage. Sixteen patients received hypervolemic hypertensive hemodilution fluid therapy; the other 16 patients received normovolemic fluid therapy. All patients were monitored for at least 12 days, with clinical assessments, transcranial Doppler recordings, single-photon emission computed tomographic (SPECT) scanning, and routine computed tomographic scanning. For fluid balance monitoring, a number of blood samples were obtained on a daily basis and continuous central venous pressure and mean arterial blood pressure measurements were performed for both groups. All patients received intravenous nimodipine infusions between Day 1 and Day 12. End points of this study were clinical outcomes, clinically evident and transcranial Doppler sonography-evident vasospasm, SPECT findings, complications, and costs. Clinical examinations (using the Glasgow Outcome Scale) performed 1 year after discharge, together with neuropsychological assessments and SPECT scanning, were the basis for the evaluation of clinical outcomes. RESULTSNo differences were observed between the two groups with respect to cerebral vasospasm (as observed clinically or on transcranial Doppler recordings). When regional cerebral blood flow was evaluated by means of SPECT analysis performed on Day 12 after subarachnoid hemorrhage, no differences were revealed. One-year clinical follow-up assessments (with the Glasgow Outcome Scale), including SPECT findings and neuropsychological function results, did not demonstrate any significant group differences. Costs were higher and complications were more frequent for the hyperdynamic therapy group. CONCLUSIONNeither early nor late outcome measures revealed any significant differences between the two subarachnoid hemorrhage treatment models.

Effect of caudal epidural steroid or saline injection in chronic lumbar radiculopathy: multicentre, blinded, randomised controlled trial

Objective To assess the efficacy of caudal epidural steroid or saline injection in chronic lumbar radiculopathy in the short (6 weeks), intermediate (12 weeks), and long term (52 weeks). Design Multicentre, blinded, randomised controlled trial. Setting Outpatient multidisciplinary back clinics of five Norwegian hospitals. Participants Between October 2005 and February 2009, 461 patients assessed for inclusion (presenting with lumbar radiculopathy >12 weeks). 328 patients excluded for cauda equina syndrome, severe paresis, severe pain, previous spinal injection or surgery, deformity, pregnancy, ongoing breast feeding, warfarin therapy, ongoing treatment with non-steroidal anti-inflammatory drugs, body mass index >30, poorly controlled psychiatric conditions with possible secondary gain, and severe comorbidity. Interventions Subcutaneous sham injections of 2 mL 0.9% saline, caudal epidural injections of 30 mL 0.9% saline, and caudal epidural injections of 40 mg triamcinolone acetonide in 29 mL 0.9% saline. Participants received two injections with a two week interval. Main outcome measures Primary: Oswestry disability index scores. Secondary: European quality of life measure, visual analogue scale scores for low back pain and for leg pain. Results Power calculations required the inclusion of 41 patients per group. We did not allocate 17 of 133 eligible patients because their symptoms improved before randomisation. All groups improved after the interventions, but we found no statistical or clinical differences between the groups over time. For the sham group (n=40), estimated change in the Oswestry disability index from the adjusted baseline value was −4.7 (95% confidence intervals −0.6 to −8.8) at 6 weeks, −11.4 (−6.3 to −14.5) at 12 weeks, and −14.3 (−10.0 to −18.7) at 52 weeks. For the epidural saline intervention group (n=39) compared with the sham group, differences in primary outcome were −0.5 (−6.3 to 5.4) at 6 weeks, 1.4 (−4.5 to 7.2) at 12 weeks, and −1.9 (−8.0 to 4.3) at 52 weeks; for the epidural steroid group (n=37), corresponding differences were −2.9 (−8.7 to 3.0), 4.0 (−1.9 to 9.9), and 1.9 (−4.2 to 8.0). Analysis adjusted for duration of leg pain, back pain, and sick leave did not change this trend. Conclusions Caudal epidural steroid or saline injections are not recommended for chronic lumbar radiculopathy. Trial registration Current Controlled Trials ISRCTN No 12574253.

A proposed set of metrics for standardized outcome reporting in the management of low back pain

Background and purpose — Outcome measurement has been shown to improve performance in several fields of healthcare. This understanding has driven a growing interest in value-based healthcare, where value is defined as outcomes achieved per money spent. While low back pain (LBP) constitutes an enormous burden of disease, no universal set of metrics has yet been accepted to measure and compare outcomes. Here, we aim to define such a set. Patients and methods — An international group of 22 specialists in several disciplines of spine care was assembled to review literature and select LBP outcome metrics through a 6-round modified Delphi process. The scope of the outcome set was degenerative lumbar conditions. Results — Patient-reported metrics include numerical pain scales, lumbar-related function using the Oswestry disability index, health-related quality of life using the EQ-5D-3L questionnaire, and questions assessing work status and analgesic use. Specific common and serious complications are included. Recommended follow-up intervals include 6, 12, and 24 months after initiating treatment, with optional follow-up at 3 months and 5 years. Metrics for risk stratification are selected based on pre-existing tools. Interpretation — The outcome measures recommended here are structured around specific etiologies of LBP, span a patient’s entire cycle of care, and allow for risk adjustment. Thus, when implemented, this set can be expected to facilitate meaningful comparisons and ultimately provide a continuous feedback loop, enabling ongoing improvements in quality of care. Much work lies ahead in implementation, revision, and validation of this set, but it is an essential first step toward establishing a community of LBP providers focused on maximizing the value of the care we deliver.

Minimally invasive decompression versus open laminectomy for central stenosis of the lumbar spine: pragmatic comparative effectiveness study

Objective To test the equivalence for clinical effectiveness between microdecompression and laminectomy in patients with central lumbar spinal stenosis. Design Multicentre observational study. Setting Prospective data from the Norwegian Registry for Spine Surgery. Participants 885 patients with central stenosis of the lumbar spine who underwent surgery at 34 Norwegian orthopaedic or neurosurgical departments. Patients were treated from October 2006 to December 2011. Interventions Laminectomy and microdecompression. Main outcome measures The primary outcome was change in Oswestry disability index score one year after surgery. Secondary endpoints were quality of life (EuroQol EQ-5D), perioperative complications, and duration of surgical procedures and hospital stays. A blinded biostatistician performed predefined statistical analyses in unmatched and propensity matched cohorts. Results The study was powered to detect a difference between the groups of eight points on the Oswestry disability index at one year. 721 patients (81%) completed the one year follow-up. Equivalence between microdecompression and laminectomy was shown for the Oswestry disability index (difference 1.3 points, 95% confidence interval −1.36 to 3.92, P<0.001 for equivalence). Equivalence was confirmed in the propensity matched cohort and full information regression analyses. No difference was found between groups in quality of life (EQ-5D) one year after surgery. The number of patients with complications was higher in the laminectomy group (15.0% v 9.8%, P=0.018), but after propensity matching for complications the groups did not differ (P=0.23). The duration of surgery for single level decompression was shorter in the microdecompression group (difference 11.2 minutes, 95% confidence interval 4.9 to 17.5, P<0.001), but after propensity matching the groups did not differ (P=0.15). Patients in the microdecompression group had shorter hospital stays, both for single level decompression (difference 1.5 days, 95% confidence interval 1.7 to 2.6, P<0.001) and two level decompression (0.8 days, 1.0 to 2.2, P=0.003). Conclusion At one year the effectiveness of microdecompression is equivalent to laminectomy in the surgical treatment of central stenosis of the lumbar spine. Favourable outcomes were observed at one year in both treatment groups. Trial registration ClinicalTrials.gov NCT02006901.

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

BackgroundTo assess safety, risk factors and clinical outcomes in elderly patients with spinal stenosis after decompressive laminectomy.MethodsA 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.ResultsThe 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.ConclusionsProperly 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.

Can we define success criteria for lumbar disc surgery?: Estimates for a substantial amount of improvement in core outcome measures

Background and purpose A successful outcome after lumbar discectomy indicates a substantial improvement. To use the cutoffs for minimal clinically important difference (MCID) as success criteria has a large potential bias, simply because it is difficult to classify patients who report that they are “moderately improved”. We propose that the criteria for success should be defined by those who report that they are “completely recovered” or “much better”. Methods A cohort of 692 patients were operated for lumbar disc herniation and followed for one year in the Norwegian Registry for Spine Surgery. The global perceived scale of change was used as an external criterion, and success was defined as those who reported that they were “completely recovered” or “much better”. Criteria for success for each of (1) the Oswestry disability index (ODI; score range 0–100 where 0 = no disability), (2) the numerical pain scale (NRS; range 0–10 where 0 = no pain) for back and leg pain, and (3) the Euroqol (EQ-5D; –0.6 to 1 where 1 = perfect health) were estimated by defining the optimal cutoff point on receiver operating characteristic curves. Results The cutoff values for success for the mean change scores were 20 (ODI), 2.5 (NRS back), 3.5 (NRS leg), and 0.30 (EQ-5D). According to the cutoff estimates, the proportions of successful outcomes were 66% for the ODI and 67% for the NRS leg pain scale. Interpretation The sensitivity/specificity values for the ODI and leg pain were acceptable, whereas they were very low for the EQ-5D. The cutoffs for success can be used as benchmarks when comparing data from different surgical units.

The risk of “getting worse” after lumbar microdiscectomy

A frequent concern among patients operated for lumbar disc herniation is the risk of “getting worse”. To give an evidence-based estimate of the risk for worsening has been difficult, since previous studies have been more focused on unfavourable outcome in general, rather than on deterioration in particular. In this prospective study of 180 patients, we report the frequency of and the risk factors for getting worse after first time lumbar microdiscectomy. Follow-up time was 12 months. Primary outcome measure was the Oswestry disability index, assessing functional status and health-related quality of life. Of the patients 4% got worse. Independent risk factors of deterioration were a long duration of sick leave and a better functional status and quality of life prior to operation. We conclude that the risk of deterioration is small, but larger if the patient has been unable to work despite relatively small health problems. This study also demonstrates that changes in instrument scores should be reported, so that an accurate failure rate can be assessed.

Serial single-photon emission computed tomographic and transcranial doppler measurements for evaluation of vasospasm after aneurysmal subarachnoid hemorrhage

OBJECTIVE:To assess the clinical value of serial single photon-emission computed tomographic (SPECT) measurements after aneurysmal subarachnoid hemorrhage (SAH). METHODS:Thirty-two patients were studied prospectively during the first 26 days after SAH with repeated SPECT measurements, clinical examinations, and transcranial Doppler recordings. Time trends were analyzed with a general linear model. A final SPECT measurement was performed after 1 year. RESULTS:A mean of 2.6 (range, 1–5) SPECT measurements revealed a significant (P = 0.001) quadratic curve consistent with initial hypoperfusion and then with hyperperfusion during the acute stage. SPECT findings were significantly associated with transcranial Doppler recordings (P = 0.016) and clinical assessments (P = 0.008). Patients fulfilling clinical and transcranial Doppler criteria for vasospasm demonstrated a more pronounced relative hypoperfusion-hyperperfusion time course. A multivariate logistic regression analysis identified SPECT measurements obtained during Days 7 to 14 after the SAH as the only independent predictor (β = 0.042, P = 0.02) for impaired perfusion after 1 year. CONCLUSION:Serial SPECT measurements after aneurysmal SAH demonstrate that regional changes in cerebral perfusion follow a nonlinear time trend, and repeated measurements are necessary. This observation, as well as the low feasibility of SPECT, restricts the clinical value of such measurements.

Accuracy of physical examination for chronic lumbar radiculopathy

BackgroundClinical examination of patients with chronic lumbar radiculopathy aims to clarify whether there is nerve root impingement. The aims of this study were to investigate the association between findings at clinical examination and nerve root impingement, to evaluate the accuracy of clinical index tests in a specialised care setting, and to see whether imaging clarifies the cause of chronic radicular pain.MethodsA total of 116 patients referred with symptoms of lumbar radiculopathy lasting more than 12 weeks and at least one positive index test were included. The tests were the straight leg raising test, and tests for motor muscle strength, dermatome sensory loss, and reflex impairment. Magnetic resonance imaging (n = 109) or computer tomography (n = 7) were imaging reference standards. Images were analysed at the level of single nerve root(s), and nerve root impingement was classified as present or absent. Sensitivities, specificities, and positive and negative likelihood ratios (LR) for detection of nerve root impingement were calculated for each individual index test. An overall clinical evaluation, concluding on the level and side of the radiculopathy, was performed.ResultsThe prevalence of disc herniation was 77.8%. The diagnostic accuracy of individual index tests was low with no tests reaching positive LR >4.0 or negative LR <0.4. The overall clinical evaluation was slightly more accurate, with a positive LR of 6.28 (95% CI 1.06–37.21) for L4, 1.74 (95% CI 1.04–2.93) for L5, and 1.29 (95% CI 0.97–1.72) for S1 nerve root impingement. An overall clinical evaluation, concluding on the level and side of the radiculopathy was also performed, and receiver operating characteristic (ROC) analysis with area under the curve (AUC) calculation for diagnostic accuracy of this evaluation was performed.ConclusionsThe accuracy of individual clinical index tests used to predict imaging findings of nerve root impingement in patients with chronic lumbar radiculopathy is low when applied in specialised care, but clinicians’ overall evaluation improves diagnostic accuracy slightly. The tests are not very helpful in clarifying the cause of radicular pain, and are therefore inaccurate for guidance in the diagnostic workup of the patients. The study population was highly selected and therefore the results from this study should not be generalised to unselected patient populations in primary care nor to even more selected surgical populations.

Does Obesity Affect Outcomes After Decompressive Surgery for Lumbar Spinal Stenosis? A Multicenter, Observational, Registry-Based Study.

OBJECTIVE To evaluate the association between obesity and outcomes 1 year after laminectomy or microdecompression for lumbar spinal stenosis (LSS). METHODS The primary outcome measure was the Oswestry Disability Index (ODI). Obesity was defined as body mass index (BMI) ≥ 30. Prospective data were retrieved from the Norwegian Registry for Spine Surgery. RESULTS For all patients (n = 1473) the mean improvement in ODI at 1 year was 16.7 points (95% CI 15.7-17.7, P < 0.001). The improvement in ODI was 17.5 points in nonobese and 14.3 points in obese patients (P = 0 .007). Obese patients were less likely to achieve a minimal clinically important difference in ODI (defined as ≥ 8 points improvement) than nonobese patients (62.2 vs. 70.3%, P = 0.013). Obesity was identified as a negative predictor for ODI improvement in a multiple regression analysis (P < 0.001). Nonobese patients experienced more improvement in both back pain (0.7 points, P = 0.002) and leg pain (0.8 points, P = 0.001) measured by numeric rating scales. Duration of surgery was shorter for nonobese patients for both single- (79 vs. 89 minutes, P = 0.001) and 2-level (102 vs. 114 minutes, P = 0.004) surgery. There was no difference in complication rates (10.4% vs. 10.8%, P = 0.84). There was no difference in length of hospital stays for single- (2.7 vs. 3.0 days, P = 0.229) or 2-level (3.5 vs. 3.6 days, P = 0.704) surgery. CONCLUSIONS Both nonobese and obese patients report considerable clinical improvement 1 year after surgery for LSS, but improvement was less in obese patients. Obese patients were less likely to achieve a minimal clinically important difference.