The Personal Impact of Epilepsy Scale (PIES) Robert S. Fisher a, ⁎, George Nune b , Sanford E. Roberts c , Joyce A. Cramer d,e a Department of Neurology and Neurological Sciences, Stanford University School of Medicine, Stanford, CA USA b Department of Neurology, Keck USC School of Medicine, Los Angeles, CA, USA c University of Pennsylvania School of Medicine, Philadelphia, PA, USA d Yale University School of Medicine, New Haven, CT, USA e Joyce Cramer Consulting, Houston, TX, USA abstract article info Article history: Received 19 August 2014 Accepted 21 September 2014 Available online 20 November 2014 Keywords: Epilepsy Seizures Scales Quality of life Side effects Comorbidity Questionnaire Depression Objective: The impact of epilepsy is manifest by effects related to seizures and side effects of therapy and comorbidities such as depression. This report describes the development of a brief patient-reported outcome (PRO) instrument, the Personal Impact of Epilepsy Scale (PIES), to measure the influence of epilepsy overall and in each of these domains. Methods: Instrument development followed standard procedures and an FDA Guidance. People with epilepsy were surveyed with open-ended questions to derive major themes of their concerns, resulting in 4 key areas: seizures, side effects, comorbidities, and overall quality of life (QOL). A preliminary set of 152 questions was based on these themes and completed by 50 patients, age 42.7 (range: 21–71) years, concurrent with comparator instruments, including the NH Seizure Severity Scale (NHSSS), the Liverpool Adverse Events Profile (LAEP), the Quality of Life in Epilepsy (QOLIE-31) scale, the Beck Depression Inventory, and the Epilepsy Foundation Depres- sion: A Checklist. A multiple regression model indicated which PIES measures were associated with scores from the comparator instruments. Questions in each of the domains were selected for correlations and nonduplication. Test–retest consistency at a 3-day interval was completed by 38 subjects and a final set of questions constructed. Results: The final question set comprised 25 items: 9 about characteristics of seizures, 7 about medication side effects, 8 about comorbidities, and 1 about overall quality of life. All items had 5 response choices (0–4), with higher scores reflecting more negative status. A total of 46 subjects completed the 25 questions. Cronbach's alpha was 0.87, indicating good internal consistency. Each of the three domains correlated well with the overall QOL item. The questions pertaining to seizures correlated with the NHSSS, the side effect questions with the LAEP, and the comorbidity questions with the QOLIE-31. Conclusion: The PIES provides a simple, brief PRO measure as a profile of overall impact of seizures, medication side effects, comorbidities, and overall QOL for people with epilepsy. Further study will explore sensitivity to change quantification of the minimal clinically significant change. © 2014 Elsevier Inc. All rights reserved. 1. Introduction Epilepsy is a multidimensional condition. Improvement in one aspect of life may coexist with deterioration in others; for example, ad- dition of a medication may result in fewer seizures but more sedation and greater irritability with family. How can a patient, family member, clinician, or clinical researcher know whether a patient with epilepsy is overall better, worse, or unchanged after a change in therapy? One simple method is to ask patients or families to answer a simple question, e.g., “How are you doing now compared to before?” A quantitative approach would be to use a Likert scale [1], typically presented with visual linear selection options. Although such global self-assessments have been validated in many circumstances, the information provided is limited. No granularity is available to ascribe changes to factors relating to seizures, side effects, or comorbidities of epilepsy. An overly simple global assessment also is subject to influences that do not direct- ly relate to epilepsy, such as financial problems or family distresses. Depression also is a factor in assessing treatment. The availability of more granular information might encourage clinicians to redirect therapy. Many instruments to measure individual aspects of epilepsy have been developed and validated, although none encapsulates all key aspects of seizures, side effects, comorbidities, and overall self-rated QOL in a single assessment. Early measurements of therapies counted only seizures. Signs, symptoms, and immediate consequences of sei- zures are primary ways to impact a person with epilepsy, but they reflect only one dimension of epilepsy [2]. Clinical trial metrics [3] Epilepsy & Behavior 42 (2015) 140–146 ⁎ Corresponding author at: Department of Neurology and Neurological Sciences, Room A343, Stanford University School of Medicine, 300 Pasteur Drive, Stanford, CA 94305-5235, USA. Tel.: +1 650 498 3056. E-mail address: robert.fisher@stanford.edu (R.S. Fisher). http://dx.doi.org/10.1016/j.yebeh.2014.09.060 1525-5050/© 2014 Elsevier Inc. All rights reserved. Contents lists available at ScienceDirect Epilepsy & Behavior journal homepage: www.elsevier.com/locate/yebeh