Functional outcome and survival following spontaneous intracerebral hemorrhage: A retrospective population-based study.

BACKGROUND: Accurate and reliable clinical and radiological predictors of intracerebral hemorrhage (ICH) outcomes are needed to optimize treatment of ICH. The aim of this study was to investigate functional outcome and identify predictors of severe disability or death following ICH. MATERIALS AND METHODS: Retrospective population-based study of spontaneous ICH. Clinical and radiological data were obtained from electronic medical records, and functional outcome estimated using the modified Rankin Scale (mRS) before ICH and at 3 and 12 months after ICH. RESULTS: Four hundred and fifty-two patients were included (mean age 74.8 years, 45.6% females). Proportion of fatal outcome at 1 week was 22.1%, at 3 months 39.2%, and at 12 months 44.9%. Median mRS score before the ICH was 1 (interquartile range [IQR] 2); for survivors at 3 months, it was 5 (IQR 3); and at 12 months, it was 3 (IQR 2). Independent predictors of severe disability (mRS of 5) or death (mRS of 6) were use of oral antithrombotic drugs (OR 2.2, 95% CI 1.3-3.8, p = 0.04), mRS score before the ICH (OR 1.8, 95% CI 1.4-2.2, p < 0.001), Glasgow Coma Scale (GCS) on admission (OR 8.3, 95% CI 3.5-19.7, p < 0.001), hematoma volume >60 ml (OR 4.5, 05% CI 2.0-10.2, p < 0.001), and intraventricular hematoma extension (OR 1.8, 95% CI 0.8-4.2, p < 0.001). CONCLUSION: Intracerebral hemorrhage is associated with high mortality, and more than one third of survivors end up with severe disability or death 3 months later. Predictors of severe disability or death were use of oral antithrombotic drugs, functional disability prior to ICH, low GCS on admission, larger hematoma volume, and intraventricular hematoma extension.

Risk of intracranial hemorrhage (RICH) in users of oral antithrombotic drugs: Nationwide pharmacoepidemiological study.

BACKGROUND: The risks of intracranial haemorrhage (ICH) associated with antithrombotic drugs outside clinical trials are gaining increased attention. The aim of this nationwide study was to investigate the risk of ICH requiring hospital admission in users of antithrombotic drugs. METHODS AND FINDINGS: Data from the Norwegian Patient Registry and Norwegian Prescription Database were linked on an individual level. The primary outcome was incidence rates of ICH associated with use of antithrombotic drugs. Secondary endpoints were risk of ICH and fatal outcome following ICH assessed by Cox models. Among 3,131,270 individuals ≥18 years old observed from 2008 through 2014, there were 729,818 users of antithrombotic medications and 22,111 ICH hospitalizations. Annual crude ICH rates per 100 person-years were 0.076 (95% CI, 0.075-0.077) in non-users and 0.30 (95% CI, 0.30-0.31) in users of antithrombotic medication, with the highest age and sex adjusted rates observed for aspirin-dipyridamole plus clopidogrel (0.44; 95% CI, 0.19-0.69), rivaroxaban plus aspirin (0.36; 95% CI, 0.16-0.56), warfarin plus aspirin (0.34; 95% CI, 0.26-0.43), and warfarin plus aspirin and clopidogrel (0.33; 95% CI, 0.073-0.60). With no antithrombotic medication as reference, the highest adjusted hazard ratios (HR) for ICH were observed for aspirin-dypiridamole plus clopidogrel (6.29; 95% CI 3.71-10.7), warfarin plus aspirin and clopidogrel (4.38; 95% CI 2.71-7.09), rivaroxaban plus aspirin (3.82; 95% CI, 2.46-5.95), and warfarin plus aspirin (3.40; 95% CI, 2.99-3.86). All antithrombotic medication regimens were associated with an increased risk of ICH, except dabigatran monotherapy (HR 1.20; 95% CI, 0.88-1.65) and dabigatran plus aspirin (HR 1.79; 95% CI, 0.96-3.34). Fatal outcome within 90 days was more common in users (2,603 of 8,055) than non-users (3,228 of 14,056) of antithrombotic medication (32.3% vs 23.0%, p<0.001), and was associated with use of warfarin plus aspirin and clopidogrel (HR 2.89; 95% CI, 1.49-5.60), warfarin plus aspirin (HR 1.37; 95% CI, 1.11-1.68), aspirin plus clopidogrel (HR 1.30; 95% CI, 1.05-1.61), and warfarin (HR 1.19; 95% CI, 1.09-1.31). Increased one-year mortality was observed in users of antithrombotic medication following hemorrhagic stroke, subdural hemorrhage, subarachnoid hemorrhage, and traumatic ICH (all p<0.001). Limitations include those inherent to observational studies including the inability to make causal inferences, certain assumptions regarding drug exposure, and the possibility of residual confounding. CONCLUSIONS: The real-world incidence rates and risks of ICH were generally higher than reported in randomized controlled trials. There is still major room for improvement in terms of antithrombotic medication safety (clinicaltrials.gov NCT02481011).

Validation of intracranial hemorrhage in the Norwegian Patient Registry.

Objectives: Administrative health registries need to have accurate diagnoses and sufficient coverage in the population they serve in order to be useful in research. In this study, we investigated the proportion of discharge diagnoses of intracranial hemorrhage (ICH) that were coded correctly in the Norwegian Patient Registry (NPR). Materials and Methods: We reviewed the electronic medical records and diagnostic imaging of all admissions to St. Olavs University Hospital, Trondheim, Norway, between January 1, 2008, to December 31, 2014, with a discharge diagnosis of ICH in the NPR, and estimated positive predictive values (PPVs) for primary and secondary diagnoses. Separate calculations were made for inpatient and outpatient admissions. Results: In total, 1,419 patients with 1,458 discharge diagnoses of ICH were included in our study. Overall, 1,333 (91.4%) discharge diagnoses were coded correctly. For inpatient admissions, the PPVs for primary discharge codes were 96.9% for hemorrhagic stroke, 95.3% for subarachnoid hemorrhage, and 97.9% for subdural hemorrhage. The most common cause of incorrect diagnosis was previous stroke that should have been coded as rehabilitation or sequela after stroke. There were more false-positive diagnoses among outpatient consultations and secondary diagnoses. Conclusion: Coding of ICH discharge diagnoses in the NPR is of high quality, showing that data from this registry can safely be used for medical research.

Lumbar microdiscectomy for sciatica in adolescents: a multicentre observational registry-based study.

BACKGROUND: Lumbar disc herniation (LDH) is rare in the adolescent population. Factors predisposing to LDH in adolescents differ from adults with more cases being related to trauma or structural malformations. Further, there are limited data on patient-reported outcomes after lumbar microdiscectomy in adolescents. Our aim was to compare clinical outcomes at 1 year following single-level lumbar microdiscectomy in adolescents (13-19 years old) compared to younger adults (20-50 years old) with LDH. METHODS: Data were collected through the Norwegian Registry for Spine Surgery. Patients were eligible if they had radiculopathy due to LDH, underwent single-level lumbar microdiscectomy between January 2007 and May 2014, and were between 13 and 50 years old at time of surgery. The primary endpoint was change in Oswestry Disability Index (ODI) 1 year after surgery. Secondary endpoints were generic quality of life (EuroQol five dimensions [EQ-5D]), back pain numerical rating scale (NRS), leg pain NRS and complications. RESULTS: A total of 3,245 patients were included (97 patients 13-19 years old and 3,148 patients 20-50 years old). A significant improvement in ODI was observed for the whole population, but there was no difference between groups (0.6; 95% CI, -4.5 to 5.8; p = 0.811). There were no differences between groups concerning EQ-5D (-0.04; 95% CI, -0.15 to 0.07; p = 0.442), back pain NRS (-0.4; 95% CI, -1.2 to 0.4; p = 0.279), leg pain NRS (-0.4; 95% CI, -1.2 to 0.5; p = 0.374) or perioperative complications (1.0% for adolescents, 5.1% for adults, p = 0.072). CONCLUSIONS: The effectiveness and safety of single-level microdiscectomy are similar in adolescents and the adult population at 1-year follow-up.

Open discectomy vs microdiscectomy for lumbar disc herniation - a protocol for a pragmatic comparative effectiveness study.

Introduction:  Since the introduction of lumbar microdiscectomy in the 1970's, many studies have attempted to compare the effectiveness of this method with that of standard open discectomy with conflicting results. This observational study is designed to compare the relative effectiveness of microdiscectomy (MD) with open discectomy (OD) for treating lumbar disc herniation, -within a large cohort, recruited from daily clinical practice. Methods and analysis:   This study will include patients registered in the Norwegian Registry for Spine Surgery (NORspine). This clinical registry collects prospective data, including preoperative and postoperative outcome measures as well as individual and demographic parameters. The primary outcome is change in Oswestry disability index between baseline and 12 months after surgery. Secondary outcome measures are improvement of leg pain and changes in health related quality of life measured by the Euro-Qol-5D between baseline and 12 months after surgery, complications to surgery, duration of surgical procedures and length of hospital stay.

Surgery for lumbar spinal stenosis in patients with rheumatoid arthritis: A multicenter observational study.

OBJECTIVE: To compare clinical outcomes following microdecompression surgery or laminectomy for central lumbar spinal stenosis (LSS) between patients with rheumatoid arthritis (RA) and patients without rheumatic disease. MATERIAL AND METHODS: Data were collected from the Norwegian Registry for Spine Surgery. The primary outcome was change in the Oswestry Disability Index (ODI) score at 1 year. The secondary endpoints were health-related quality of life that was measured using the Euro-Qol-5D (EQ-5D), back pain numerical rating scale (NRS), leg pain NRS, and complications. RESULTS: A total of 1433 patients were included (1396 controls and 37 patients with RA). For all the patients, there was an improvement in ODI score 16.7 points; 95% confidence interval (CI), 15.7, 17.7; p<0.001). There were no differences between controls and patients with RA with respect to the mean changes of ODI scores (-2.5 points; 95% CI, -9.0 to 4.1; p=0.462), EQ-5D (p=0.295), back pain NRS (p=0.194), leg pain NRS (p=0.927), and complications within 3 months of surgery (12.8% vs. 13.5%, p=0.806). At 1 year, 68.6% (n=775) of controls had achieved a minimal clinically important difference (≥8 points ODI score improvement) compared with 65.5% (n=19) of patients with RA (p=0.726). CONCLUSION: Patients with RA experienced similar and large improvements in patient-reported outcomes following surgical decompression for LSS compared with patients without rheumatic disease. There was no increased risk of complications in patients with RA.

Surgery for Lumbar Spinal Stenosis in Individuals Aged 80 and Older: A Multicenter Observational Study.

OBJECTIVES: To compare clinical outcomes after decompressive surgery for central lumbar spinal stenosis (LSS) in individuals aged 80 and older with those of individuals aged 18-79. DESIGN: Prospective data from the Norwegian Registry for Spine Surgery. SETTING: Multicenter observational study. PARTICIPANTS: Individuals with central LSS undergoing surgery at 36 orthopedic or neurosurgical departments (N = 1,503; 1,325 aged <80 (median 66, range 21-79); 178 aged ≥80 (median 82, range 80-95)). INTERVENTION: Laminectomy or microdecompression. MEASUREMENTS: Changes in Oswestry Disability Index (ODI), EuroQol 5D (EQ-5D), back pain numerical rating scale (NRS), and leg pain NRS at 1 year. Complications and duration of surgical procedures and hospital stays are reported. RESULTS: For all participants, there was a significant improvement in ODI (difference 16.60 points, 95% confidence interval (CI) = 15.59-17.61, P < .001). There were no differences between age cohorts in mean changes in ODI (0.2, 95% CI = -3.05-3.39, P = .92), EQ-5D (0.02, 95% CI = -0.04-0.09, P = .49), back pain NRS (-0.2, 95% CI = -0.7-0.4, P = .56), or leg pain NRS (-0.1, 95% CI = -0.7-0.5), P = .77). There were no differences in perioperative complications between age cohorts (4.9% vs 7.9%, P = .11). Participants aged 80 and older reported more complications occurring within 3 months (11.8% vs 7.5%, P = .02), mainly because of more urinary tract infections (9.6% vs 3.5%, P = .001). Mean duration of hospital stays was 1.3 days longer for participants aged 80 and (4.5 vs 3.2 days, P < .001). There were no differences in duration of single-level microdecompression (P = .94), two-level microdecompression (P = .53), single-level laminectomy (P = .78), or two-level laminectomy (P = .08). CONCLUSION: Individuals aged 80 and older experience improvement in self-reported outcomes similar to those of younger individuals after decompressive surgery for LSS.

Is There an Association Between Radiological Severity of Lumbar Spinal Stenosis and Disability, Pain, or Surgical Outcome?: A Multicenter Observational Study.

STUDY DESIGN: Observational multicenter study. OBJECTIVE: To evaluate if the severity of lumbar spinal stenosis (LSS) on magnetic resonance imaging (MRI) correlates with preoperative disability, pain, or surgical outcomes. SUMMARY OF BACKGROUND DATA: Surgeons use the morphological appearance of LSS on MRI for clinical decision making. However, the associations between radiological severity of LSS and disability, pain, or surgical outcomes remain unclear. METHODS: Evaluation of severity of LSS on preoperative MRI according to the Schizas morphological classification. Patient and treatment data were retrieved from the Norwegian Registry for Spine Surgery. Preopertaive outcome measures were Oswestry disability index (ODI) and numeric rating scale (NRS) scores for back and leg pain. Postopertive outcome measures were ODI and NRS scores for back and leg pain at 1 year, changes in ODI and NRS scores after treatment, duration of surgery, length of hospital stay, and perioperative complications. RESULTS: Of 202 patients included, 7 were found to have mild stenosis, 38 had moderate stenosis, 108 had severe stenosis, and 49 had extreme stenosis. The radiological severity of LSS was not linked to preoperative ODI (P = 0.089), NRS back pain (P = 0.273), or NRS leg pain (P = 0.282) scores. There were no differences in ODI (P = 0.933), NRS back pain (P = 0.652), or NRS leg pain (P = 0.912) scores after 1 year. The radiological severity of stenosis was not associated with change in ODI (P = 0.494), NRS back pain (P = 0.235), NRS leg pain (P = 0.790), duration of surgery (P = 0.661), length of hospital stay (P = 0.739), or perioperative complication rates (P = 0.467). CONCLUSION: Among patients who underwent decompressive surgery for LSS, radiological severity of stenosis was not associated with preoperative disability and pain, or clinical outcomes 1 year after surgery. In this patient group, the radiological severity of LSS has no clear clinical correlation and should therefore not be overemphasized in clinical decision making. LEVEL OF EVIDENCE: 2.

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.

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

OBJECTIVE: To investigate the frequency and predictors of deterioration after decompressive surgery for single and 2-level lumbar spinal stenosis. METHODS: Prospectively 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. RESULTS: There 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). CONCLUSIONS: Overall 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.

Does daily tobacco smoking affect outcomes after microdecompression for degenerative central lumbar spinal stenosis? - A multicenter observational registry-based study.

BACKGROUND: There are limited scientific data on the impact of smoking on patient-reported outcomes following minimally invasive spine surgery. The aim of this multicenter observational study was to examine the relationship between daily smoking and patient-reported outcome at 1 year using the Oswestry Disability Index (ODI) after microdecompression for single- and two-level central lumbar spinal stenosis (LSS). Secondary outcomes were the length of hospital stays, perioperative and postoperative complications. METHOD: Data were collected through the Norwegian Registry for Spine Surgery (NORspine). RESULTS: A total of 825 patients were included (619 nonsmokers and 206 smokers). For the whole patient population there was a significant difference between preoperative ODI and ODI at 1 year (17.3 points, 95% CI 15.93-18.67, p < 0.001). There was a significant difference in ODI change at 1 year between nonsmokers and smokers (4.2 points, 95% CI 0.98-7.34, p = 0.010). At 1 year 69.6% of nonsmokers had achieved a minimal clinically important difference (≥10 points ODI improvement) compared to 60.8% of smokers (p = 0.008). There was no difference between nonsmokers and smokers in the overall complication rate (11.6% vs. 9.2%, p = 0.34). There was no difference between nonsmokers and smokers in length of hospital stays for either single-level (2.3 vs. 2.2 days, p = 0.99) or two-level (3.1 vs. 2.3 days, p = 0.175) microdecompression. Smoking was identified as a negative predictor for ODI change in a multiple regression analysis (p = 0.001) CONCLUSIONS: Nonsmokers experienced a significantly larger improvement at 1 year following microdecompression for LSS compared to smokers. Smokers were less likely to achieve a minimal clinically important difference. However, it should be emphasized that considerable improvement also was found among smokers.

Microsurgical decompression for central lumbar spinal stenosis: a single-center observational study.

OBJECTIVE: To assess outcomes and complications in patients undergoing microsurgical decompression for central lumbar spinal stenosis (LSS) without radiologic instability. METHODS: Prospective data for patients operated at the Department of Neurosurgery, St. Olavs University Hospital, Norway, were obtained from the Norwegian Registry for Spine Surgery (NORspine) from 2007 to 2012. The primary outcome was change in Oswestry disability index (ODI) at 1 year. The secondary endpoint was perioperative complications. Complications were graded according to the Ibanez classification system. RESULTS: For all patients (n = 125), the mean improvement in ODI at 1 year was 16.9 points (95% CI 13.5-20.2, p < 0.001). Seventy-six (71.7%) patients achieved a minimal clinically important difference in ODI (defined as ≥8 points improvement). The total number of complications within 3 months of surgery was 22 (17.6%). There were 14 medical and eight surgical complications, and all were Ibanez grade I or II (mild or moderate) complications. Four (3.2%) complications occurred while being admitted to the hospital and 18 (14.4%) occurred within 3 months following hospital discharge. The most common complication was urinary tract infection (n = 11, 8.8%). CONCLUSIONS: Microsurgical decompression for central LSS in the absence of radiological instability is an effective and safe treatment.

Risk of intracranial hemorrhage in users of oral antithrombotic drugs: Study protocol for a nationwide study.

Background A wide range of antithrombotic medications can be used in the prevention and treatment of thrombosis. Among hemorrhagic complications of antithrombotic drugs, intracranial hemorrhage may have particularly devastating consequences with high morbidity, disability and mortality rates. The incidence and risks of intracranial hemorrhage in patients on antithrombotic treatments from regular clinical practice outside clinical trials remain largely unknown. It is not known if results from clinical trials can be extrapolated to everyday clinical practice. We will conduct a nationwide study to investigate the risks and incidence rates of intracranial hemorrhage in users oral antithrombotic drugs in Norway from 2008 through 2014.   Methods and design The aim of this nationwide study is to investigate the incidence rates of intracranial hemorrhage requiring hospitalization in users of oral antithrombotic drugs. The study will be conducted within the approximately 4.7 million inhabitants of Norway from January 1 (st), 2008, to December 31 (st), 2014. Treatment and outcome data are obtained from the Norwegian patient registry and the Norwegian prescription database.   Trial registration number Clinicaltrials.gov (NCT02481011).