| 1. |
- Gulati, Sasha, et al.
(författare)
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Lumbar microdiscectomy for sciatica in adolescents: a multicentre observational registry-based study.
- 2017
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Ingår i: Acta neurochirurgica. - : Springer Science and Business Media LLC. - 0942-0940 .- 0001-6268. ; 159:3, s. 509-516
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Tidskriftsartikel (refereegranskat)abstract
- 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 (13-19years old) compared to younger adults (20-50years old) with LDH.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 50years 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.A total of 3,245 patients were included (97 patients 13-19years old and 3,148 patients 20-50years 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).The effectiveness and safety of single-level microdiscectomy are similar in adolescents and the adult population at 1-year follow-up.
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| 2. |
- Gulati, Sasha, et al.
(författare)
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Risk of intracranial hemorrhage in users of oral antithrombotic drugs: Study protocol for a nationwide study
- 2015
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Ingår i: F1000 Research. - : F1000 Research Ltd. - 2046-1402. ; 4
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Tidskriftsartikel (refereegranskat)abstract
- 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 1st, 2008, to December 31st, 2014. Treatment and outcome data are obtained from the Norwegian patient registry and the Norwegian prescription database.
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| 3. |
- Gulati, Sasha, et al.
(författare)
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Risk of intracranial hemorrhage (RICH) in users of oral antithrombotic drugs: Nationwide pharmacoepidemiological study.
- 2018
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Ingår i: PloS one. - : Public Library of Science (PLoS). - 1932-6203. ; 13:8
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Tidskriftsartikel (refereegranskat)abstract
- 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.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.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).
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| 4. |
- Øie, Lise R, et al.
(författare)
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Functional outcome and survival following spontaneous intracerebral hemorrhage: A retrospective population-based study.
- 2018
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Ingår i: Brain and behavior. - : Wiley. - 2162-3279. ; 8:10
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Tidskriftsartikel (refereegranskat)abstract
- 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.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 12months after ICH.Four hundred and fifty-two patients were included (mean age 74.8years, 45.6% females). Proportion of fatal outcome at 1week was 22.1%, at 3months 39.2%, and at 12months 44.9%. Median mRS score before the ICH was 1 (interquartile range [IQR] 2); for survivors at 3months, it was 5 (IQR 3); and at 12months, 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 >60ml (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).Intracerebral hemorrhage is associated with high mortality, and more than one third of survivors end up with severe disability or death 3months 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.
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