Evidence map›Paper›PMID 30866058›Full record

Observational studyEpilepsia2019

Validated outcome of treatment changes according to International League Against Epilepsy criteria in adults with drug-resistant focal epilepsy.

Marco Mula, Gaetano Zaccara, Carlo Andrea Galimberti, Bruno Ferrò, Maria Paola Canevini, Addolorata Mascia, Oriano Mecarelli, Roberto Michelucci, Laura Rosa Pisani, Luigi Maria Specchio and 2 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Epilepsia, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Review
  13. Observational
  14. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Marco MulaInstitute of Medical and Biomedical Education, St George's University of London and Atkinson Morley Regional Neuroscience Centre, St George's University Hospitals National Health Service Foundation Trust, London, UK.ORCID 0000-0002-9415-3395
Gaetano ZaccaraRegional Health Agency of Tuscany, Florence, Italy.
Carlo Andrea GalimbertiC. Mondino National Neurological Institute, Pavia, Italy.
Bruno FerròUCB Pharma, Milan, Italy.
Maria Paola CaneviniDepartment of Health Sciences, University of Milan, Epilepsy Center, San Paolo Hospital, Milan, Italy.
Addolorata MasciaIRCCS Neuromed, Pozzilli, Italy.
Oriano MecarelliDepartment of Human Neurosciences, Sapienza University, Rome, Italy.
Roberto MichelucciIRCCS Istituto delle Scienze Neurologiche di Bologna, UOC Neurologia Ospedale Bellaria, Bologna, Italy.
Laura Rosa PisaniNeurology Unit, Cutrona-Zodda Hospital, Barcellona Pozzo di Gotto, Italy.
Luigi Maria SpecchioUniversity of Foggia, Foggia, Italy.
Salvatore StrianoDepartment of Neuroscience and Reproductive and Odontostomatological Sciences, School of Medicine, Federico II Epilepsy Center, University of Naples, Naples, Italy.
Emilio PeruccaClinical Pharmacology Unit, Department of Internal Medicine and Therapeutics, University of Pavia and Clinical Trial Center, IRCCS Mondino Foundation, Pavia, Italy.

Funding

UCB Pharma
6 · The paper itself

Abstract

objectiveAlthough many studies have attempted to describe treatment outcomes in patients with drug-resistant epilepsy, results are often limited by the adoption of nonhomogeneous criteria and different definitions of seizure freedom. We sought to evaluate treatment outcomes with a newly administered antiepileptic drug (AED) in a large population of adults with drug-resistant focal epilepsy according to the International League Against Epilepsy (ILAE) outcome criteria.

methodsThis is a multicenter, observational, prospective study of 1053 patients with focal epilepsy diagnosed as drug-resistant by the investigators. Patients were assessed at baseline and 6, 12, and 18 months, for up to a maximum of 34 months after introducing another AED into their treatment regimen. Drug resistance status and treatment outcomes were rated according to ILAE criteria by the investigators and by at least two independent members of an external expert panel (EP).

resultsA seizure-free outcome after a newly administered AED according to ILAE criteria ranged from 11.8% after two failed drugs to 2.6% for more than six failures. Significantly fewer patients were rated by the EP as having a "treatment failure" as compared to the judgment of the investigator (46.7% vs 62.9%, P < 0.001), because many more patients were rated as "undetermined outcome" (45.6% vs 27.7%, P < 0.001); 19.3% of the recruited patients were not considered drug-resistant by the EP. SIGNIFICANCE: This study validates the use of ILAE treatment outcome criteria in a real-life setting, providing validated estimates of seizure freedom in patients with drug-resistant focal epilepsy in relation to the number of previously failed AEDs. Fewer than one in 10 patients achieved seizure freedom on a newly introduced AED over the study period. Pseudo drug resistance could be identified in one of five cases.

Indexed as

AdolescentAdultAgedAged, 80 and overAnticonvulsantsDrug Resistant EpilepsyEpilepsies, PartialFemaleHumansMaleMiddle AgedProspective StudiesReproducibility of ResultsTreatment OutcomeYoung AdultAnticonvulsantsantiepileptic drugsdrug-resistant epilepsyepilepsyoutcometreatment

Identifiers

PMID30866058
PMCPMC6850288

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.