Defining minimally important change in QOLIE-31 scores: estimates from three placebo-controlled lacosamide trials in patients with partial-onset seizures

Epilepsy & Behavior : E&B
Simon BorghsJ A Cramer

Abstract

The Quality of Life Inventory in Epilepsy (QOLIE-31) is a valuable tool to assess the impact of antiepileptic drugs on patients' lives, but interpretation of mean score changes can be challenging. Minimally important change (MIC) thresholds can be used to describe the proportion of clinically improved or worsened patients. Pooled data from Phase II/III trials of adjunctive lacosamide in patients with treatment-resistant partial-onset seizures were used to estimate MIC thresholds for the QOLIE-31 total score and subscales. Using multiple distribution- and anchor-based estimation methods, the optimal MIC value for the total score in this population of patients with treatment-resistant seizures was 5 points, which is lower than those previously reported in the literature for mixed populations. MIC estimates varied substantially across QOLIE-31 subscales. Taken together, these results demonstrate that intrinsic characteristics of a patient population impact what should be considered as MIC, a key consideration in the clinical interpretation of QOLIE-31 change scores.

References

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Citations

Sep 13, 2015·Seizure : the Journal of the British Epilepsy Association·Wendy Waldman ZadehUNKNOWN SP0954 Study Group
Dec 15, 2015·Neuromodulation : Journal of the International Neuromodulation Society·Robert S FisherBita Najimipour
Nov 11, 2015·Seizure : the Journal of the British Epilepsy Association·Paul BoonRyan M McGuire
Mar 2, 2016·Epilepsy & Behavior : E&B·Joyce A Cramer
Apr 9, 2016·Drugs·Matt Shirley, Sohita Dhillon
Oct 22, 2013·Epilepsy & Behavior : E&B·Joyce A CramerSimon Borghs
Dec 3, 2014·Epilepsy & Behavior : E&B·Robert S FisherJoyce A Cramer
Jul 9, 2016·BMC Medical Research Methodology·Åsa NordinAnna Dencker
Aug 30, 2017·Complementary Medicine Research·Rosa MichaelisBettina Berger
Jul 19, 2017·The Cochrane Database of Systematic Reviews·Mathieu SprengersPaul Boon
Oct 28, 2017·The Cochrane Database of Systematic Reviews·Rosa MichaelisMarkus Reuber
May 15, 2018·Neurological Sciences : Official Journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology·Massimo PiacentinoPaolo Bonanni
Aug 16, 2019·Journal of Neurology·Robert QuonBarbara Jobst
Jun 7, 2019·Epilepsia Open·Gagandeep SinghJosemir W Sander
Nov 29, 2020·Epilepsy & Behavior : E&B·Benzi M KlugerMark Spitz
Jul 27, 2021·Epilepsy & Behavior : E&B·Gilvano Amorim OliveiraLuciana Bertoldi Nucci

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