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Seizure 05/2012; 21(7):559-60. · 1.80 Impact Factor
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E Mawhinney,
J Campbell, J Craig,
A Russell,
W Smithson,
L Parsons,
I Robertson,
B Irwin,
P Morrison,
B Liggan,
N Delanty,
S Hunt,
J Morrow
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ABSTRACT: Use of valproate in pregnancy, especially in doses over 1000mg a day, is known to be associated with a higher risk for major congenital malformations compared with other antiepileptic drugs. We sought to investigate whether the increased risk could be minimised by using controlled release or divided daily doses of valproate.
The UK Epilepsy and Pregnancy Register is a prospective, observational and follow up study set up to determine the risks of major congenital malformations for infants exposed to antiepileptic drugs in utero. In this study we have extracted data for those pregnancies exposed to valproate in monotherapy. We have calculated malformation rates and relative risks as a function of valproate exposure.
Outcome data were available for 1109 pregnancies exposed to valproate in monotherapy. Exposure to 1000mg a day or more of valproate was associated with almost double the risk of major congenital malformation compared with daily valproate doses below 1000mg daily (8.86% vs 4.88%, RR: 1.7; 95% CI: 1.1-2.9). There were no differences in the risks for malformations between standard release valproate and controlled release valproate preparations (RR: 1.11; 95% CI: 0.67-1.83) or for those exposed to single or multiple daily administrations (RR: 0.99, 95% CI: 0.58-1.70).
Prescribing controlled release valproate or multiple daily administrations in pregnancy did not reduce the risk for malformations. Higher malformation rates observed with in utero exposure to valproate are more likely related to total daily dose, rather than peak serum levels.
Seizure 04/2012; 21(3):215-8. · 1.80 Impact Factor
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F Kennedy,
J Morrow,
S Hunt,
A Russell,
W H Smithson,
L Parsons,
I Robertson,
B Irwin,
N Delanty,
P J Morrison, J Craig
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ABSTRACT: Aim To assess the relative risk of major congenital malformations (MCM) from exposure to anti-epileptic drugs (AEDs) during pregnancy. Methods 15 year prospective observational study from 1996 until 2009. The outcome measure is the MCM rate. Results Informative outcomes were available for 5802 cases. The risk of MCM was significantly higher in women on AEDs during pregnancy (n=5376) in comparison to those on no treatment (n=426), RR: 1.55 (95% CI 1.13 to 2.14), and significantly higher in polytherapy (n=1183) than monotherapy (n=4193), RR: 1.60 (95% CI 1.19 to 2.15). The risk to those on valproate monotherapy was more than double that for those on either carbamazepine (RR 2.35, 95% CI 1.55 to 3.57) or lamotrigene (RR 2.40, 95% CI 1.57 to 3.68). 245 and 362 informative outcomes were obtained for topiramate and levetiracetam respectively, with MCM rates of 7.1% (95% CI 4.5 to 11.0%) and 2.5% (95% CI 1.3 to 4.7%). There were 3/83 cases of MCM in Topiramate monotherapy and 14/162 cases in polytherapy. There were no cases of MCMs in levetiracetam monotherapy and 9/229 cases levetiracetam polytherapy. Conclusions AED exposure during pregnancy increases the risk of MCM in the babies of women with epilepsy. Polytherapy exposure has a higher risk than monotherapy. Valproate exposure carries higher MCM risk than any other AED. Lowest risk is associated with carbamazepine or lamotrigene monotherapy. Results for levetiracetam, although numbers are small, look promising.
Journal of neurology, neurosurgery, and psychiatry 11/2010; 81(11):e18. · 4.87 Impact Factor
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ABSTRACT: Topiramate (Topamax) is licensed to be used, either in monotherapy or as adjunctive treatment, for generalized tonic clonic seizures or partial seizures with or without secondary generalization and for prevention of migraine. The safety of topiramate in human pregnancy is largely unknown. Here we report on our experience of pregnancies exposed to topiramate.
This study is part of a prospective, observational, registration and follow-up study. Suitable cases are women with epilepsy who become pregnant while taking topiramate either singly or along with other antiepileptic drugs (AEDs), and who are referred before outcome of the pregnancy is known. The main outcome measure is the major congenital malformation (MCM) rate. Secondary outcomes include risk of specific MCM, minor malformation rate, birthweight, and gestational age at delivery.
Full outcome data are available on 203 pregnancies. Of these, 178 resulted in live birth; 16 had an MCM (9.0%; 95% CI 5.6% to 14.1%). Three MCMs were observed in 70 monotherapy exposures (4.8%; 95% CI 1.7% to 13.3%) and 13 in cases exposed to topiramate as part of a polytherapy regimen (11.2%; 95% CI 6.7% to 18.2%). Four of the MCMs were oral clefts (2.2%; 95% CI 0.9% to 5.6%). Four cases of hypospadias were reported (5.1%; 95% CI 0.2% to 10.1%) among 78 known live male births of which two were classified as major malformations.
The number of outcomes of human pregnancies exposed to topiramate is low, but the major congenital malformation rate for topiramate polytherapy raises some concerns. Overall, the rate of oral clefts observed was 11 times the background rate. Although the present data provide new information, they should be interpreted with caution due to the sample size and wide confidence intervals.
Neurology 07/2008; 71(4):272-6. · 8.31 Impact Factor
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ABSTRACT: It is not known whether the antiepileptic drug (AED) levetiracetam can be used safely in human pregnancy. As part of a study to determine the risks of major congenital malformations (MCMs) for infants exposed to AEDs in utero, we identified all cases exposed to levetiracetam. Three of 117 exposed pregnancies had an MCM (2.7%; 95% CI 0.9% to 7.7%); all 3 were exposed to other AEDs.
Neurology 12/2006; 67(10):1876-9. · 8.31 Impact Factor
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ABSTRACT: To assess the relative risk of major congenital malformation (MCM) from in utero exposure to antiepileptic drug (AEDs).
Prospective data collected by the UK Epilepsy and Pregnancy Register were analysed. The presence of MCMs recorded within the first three months of life was the main outcome measure.
Full outcome data were collected on 3607 cases. The overall MCM rate for all AED exposed cases was 4.2% (95% confidence interval (CI), 3.6% to 5.0%). The MCM rate was higher for polytherapy (6.0%) (n = 770) than for monotherapy (3.7%) (n = 2598) (crude odds ratio (OR) = 1.63 (p = 0.010), adjusted OR = 1.83 (p = 0.002)). The MCM rate for women with epilepsy who had not taken AEDs during pregnancy (n = 239) was 3.5% (1.8% to 6.8%). The MCM rate was greater for pregnancies exposed only to valproate (6.2% (95% CI, 4.6% to 8.2%) than only to carbamazepine (2.2% (1.4% to 3.4%) (OR = 2.78 (p<0.001); adjusted OR = 2.97 (p<0.001)). There were fewer MCMs for pregnancies exposed only to lamotrigine than only to valproate. A positive dose response for MCMs was found for lamotrigine (p = 0.006). Polytherapy combinations containing valproate carried a higher risk of MCM than combinations not containing valproate (OR = 2.49 (1.31 to 4.70)).
Only 4.2% of live births to women with epilepsy had an MCM. The MCM rate for polytherapy exposure was greater than for monotherapy exposure. Polytherapy regimens containing valproate had significantly more MCMs than those not containing valproate. For monotherapy exposures, carbamazepine was associated with the lowest risk of MCM.
Journal of Neurology Neurosurgery & Psychiatry 03/2006; 77(2):193-8. · 4.76 Impact Factor
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ABSTRACT: To find out the effect of early neurological consultation using a real time video link on the care of patients with neurological symptoms admitted to hospitals without neurologists on site.
A cohort study was performed in two small rural hospitals: Tyrone County Hospital (TCH), Omagh, and Erne Hospital, Enniskillen. All patients over 12 years of age who had been admitted because of neurological symptoms, over a 24 week period, to either hospital were studied. Patients admitted to TCH, in addition to receiving usual care, were offered a neurological consultation with a neurologist 120 km away at the Neurology Department of the Royal Victoria Hospital, Belfast, using a real time video link. The main outcome measure was length of hospital stay; change of diagnosis, mortality at 3 months, inpatient investigation, and transfer rate and use of healthcare resources within 3 months of admission were also studied.
Hospital stay was significantly shorter for those admitted to TCH (hazard ratio 1.13; approximate 95% CI 1.003 to 1.282; p = 0.045). No patients diagnosed by the neurologist using the video link subsequently had their diagnosis changed at follow up. There was no difference in overall mortality between the groups. There were no differences in the use of inpatient hospital resources and medical services in the follow up period between TCH and Erne patients.
Early neurological assessment reduces hospital stay for patients with neurological conditions outside of neurological centres. This can be achieved safely at a distance using a real time video link.
Journal of Neurology Neurosurgery & Psychiatry 08/2004; 75(7):1031-5. · 4.76 Impact Factor
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ABSTRACT: To test the hypothesis that telemedicine for new patient referrals to neurological outpatients is as efficient and acceptable as conventional face to face consultation.
A randomised controlled trial between two groups: face to face (FF) and telemedicine (TM). This study was carried out between a neurological centre and outlying clinics at two distant hospitals linked by identical medium cost commercial interactive video conferencing equipment with ISDN lines transmitting information at 384 kbits/s. The same two neurologists carried out both arms of the study. Of the 168 patients who were suitable for the study, 86 were randomised into the telemedicine group and 82 into the face to face group. Outcome measures were (1) consultation process: (a) number of investigations; (b) number of drugs prescribed; (c) number of patient reviews and (2) patient satisfaction: (a) confidence in consultation; (b) technical aspects of consultation; (c) aspects surrounding confidentiality. Diagnostic categories were also measured to check equivalence between the groups: these were structural neurological, structural non-neurological, non-structural, and uncertain.
Diagnostic categories were similar (p>0.5) between the two groups. Patients in the telemedicine group had significantly more investigations (p=0.001). There was no difference in the number of drugs prescribed (p>0.5). Patients were generally satisfied with both types of consultation process except for concerns about confidentiality and embarrassment in the telemedicine group (p=0.017 and p=0.005 respectively).
Telemedicine for new neurological outpatients is possible and feasible but generates more investigations and is less well accepted than face to face examination.
Journal of Neurology Neurosurgery & Psychiatry 07/2001; 71(1):63-6. · 4.76 Impact Factor
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ABSTRACT: A randomized controlled trial was conducted to compare the costs of realtime teleneurology with the cost of conventional neurological care. Two district hospitals in Northern Ireland were equipped with videoconferencing units and were connected to the regional neurological centre by ISDN at 384 kbit/s. Of 168 patients randomized to the study, 141 kept their appointments (76 male, 65 female). Sixty-five patients were randomized to a conventional consultation while 76 were randomized to a teleconsultation. The average age was 44 years of those seen conventionally and 42 years of those seen by telemedicine. The groups had similar diagnoses. The telemedicine group required more investigations and reviews than the conventional group. The average cost of the conventional consultation was 49 pounds sterling compared with 72 pounds sterling for the teleconsultation. Realtime teleneurology was not as cost-effective as conventional care.
Journal of Telemedicine and Telecare 02/2001; 7 Suppl 1:62-4. · 1.21 Impact Factor
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ABSTRACT: To evaluate the feasibility of interactive videoconsultation (IATV) as a means by which neurologists might assess patients admitted with neurological symptoms to hospitals distant from a neurological centre, we studied 25 unselected patients using interactive videoconsultation (IATV) and then validated the IATV diagnoses and management plans at a later face-to-face consultation. IATV consultation led to an eventual diagnosis in 23 out of 25 patients, with one diagnosis being changed and one remaining uncertain. The IATV management plans were felt to be appropriate for all patients in study. Twelve patients were able to be discharged from hospital on the same day as IATV on the advice of the neurologist. It is therefore practical to assess patients admitted with neurological symptoms to distant hospitals using IATV and this may result in more efficient use of in-patient resources.
European Journal of Neurology 12/2000; 7(6):699-702. · 3.69 Impact Factor
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ABSTRACT: We investigated whether new patients attending a neurological outpatient clinic could be safely managed by neurologists at a distance, using a video-link. In Northern Ireland, a video-link, transmitting at 384 kbit/s, was set up between a neurological centre and a small rural hospital 140 km away. Twenty-five unselected patients who had been referred by their family doctor were assessed by a neurologist using the telemedicine link and then immediately by another neurologist face to face. Examiners were blinded to the results of each other's assessment. In 24 cases the diagnoses made after the telemedicine and face-to-face examinations were identical. There were minor differences between the type and number of investigations requested, and the requirements for treatment and follow-up between the two groups. Disposal method was the same in 21 of the cases. No major organizational difficulties were encountered during the study. The study showed that neurologists can deliver outpatient neurological care to distant patients using telemedicine. This has the potential to allow access to assessment for the large number of neurological outpatients who might otherwise be denied it.
Journal of Telemedicine and Telecare 02/2000; 6(4):225-8. · 1.21 Impact Factor
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ABSTRACT: We are currently evaluating the use of telemedicine for improving the care of patients admitted with neurological symptoms to hospitals that do not have specialist neurologists on site. To do this we have been comparing the outcome of patients admitted to two small hospitals. In one hospital all patients with neurological symptoms are seen by a neurologist at a distance using an interactive video-link transmitting at 384 kbit/s; in the other patients with neurological problems are managed as per usual practices. For the results of this study to be valid, it is essential that the case-mix and process of management for neurological patients are similar at the two hospitals. We therefore compared the case-mix, process of management, and outcome for all patients admitted over a four-month period to either hospital who had been coded using ICD-10 as having a final diagnosis of a neurological condition. No appreciable differences were noted between the two hospitals for measures of case-mix or outcome. Likewise, most measures of process were similar, although there was a significant difference for the overall length of hospital episode between the two hospitals. When patients with prolonged hospital episodes were excluded, or only patients with a diagnosis of headache, epilepsy or transient ischaemic attack were considered (who as a group made up the bulk of neurological admissions), the difference in the length of hospital episode was not significant. It should therefore be possible for us to estimate the effect of telemedicine on the management of patients with neurological problems.
Journal of Telemedicine and Telecare 02/2000; 6 Suppl 1:S46-9. · 1.21 Impact Factor
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Seizure 07/1999; 8(4):253-4. · 1.80 Impact Factor
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Journal of Telemedicine and Telecare 02/1999; 5(2):134-6. · 1.21 Impact Factor
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ABSTRACT: User satisfaction (i.e. that of patients, medical staff at a remote hospital and medical staff at a neurological centre) with realtime teleneurology consultations was studied prospectively. Twenty-five patients with neurological problems admitted to a hospital without permanent neurological cover were assessed from a neurological centre by specialist neurologists using realtime video-links transmitting at 384 kbit/s. All users reported high levels of satisfaction with the technical aspects of the consultations. Patients, almost universally, reported confidence in teleneurology as a means of dealing with their presenting complaints. Similarly, medical staff at either site felt confident in managing patients using teleneurology and almost always felt that a telephone consultation would not have achieved as good an outcome. No major organizational problems were identified. These findings suggest overall user satisfaction with realtime teleneurology for managing patients with neurological problems admitted to hospitals that do not have resident neurologists.
Journal of Telemedicine and Telecare 02/1999; 5(4):237-41. · 1.21 Impact Factor
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