Caroline Selai

Antiepileptic Drugs and the Regulation of Mood and Quality of Life (QOL): The Evidence from Epilepsy

Summary:  We review the literature on the influence of antiepileptic drugs (AEDs) on mood and quality of life in patients with epilepsy. Although many anecdotal reports cover a spectrum of AEDs, most of the controlled data have come from studies of carbamazepine and lamotrigine. Both of these compounds appear to have positive effects on mood, and these data parallel the effects noted in nonepilepsy populations. AEDs that are γ‐aminobutyric acid (GABA)ergic tend to have negative effects on mood, and an affective disorder is often noted as a treatment‐emergent effect. It is speculated that the amygdala is an important anatomic structure in the cerebral circuits that regulate mood in affective disorders but also in epilepsy, and an effect of AEDs on such circuits aids mood stability in both populations of patients.

Measuring quality of life in PSP: the PSP-QoL.

Objective: To develop a new patient-reported outcome measure for progressive supranuclear palsy (PSP) and to test its psychometric properties. Methods: First, the authors generated a pool of potential scale items from in-depth patient interviews. Second, the authors administered these items, in the form of a questionnaire, to a sample of people with PSP and traditional psychometric methods were used to develop a rating scale satisfying standard criteria for reliability and validity. Third, the authors examined the psychometric properties of the rating scale in a second sample. Results: In stage 1, a pool of 87 items was generated from 27 patient interviews. In stage 2, a scale with two subscales (physical, 22 items; mental, 23 items), satisfying standard criteria for reliability and validity, was developed from the response data of 225 patients with PSP. In stage 3, the scale was examined in 188 people with PSP. Missing data were low, scores in both subscales were evenly distributed, floor and ceiling effects were small. Reliability was high (Cronbach’s alpha 0.93, 0.95; test-retest 0.95, 0.92). Validity was supported by the interscale intercorrelation (0.60), factor analysis, and the magnitude and pattern of correlations with four other rating scales, disease severity, and disease duration. The psychometric properties of the new scale were similar in the United Kingdom and North America, and in clinic- and community-based samples studied. Conclusions: The Progressive Supranuclear Palsy Quality of Life scale (PSP-QoL) may be a helpful patient-reported scale for clinical trials and studies in PSP.

From translation to version management: a history and review of methods for the cultural adaptation of the EuroQol five-dimensional questionnaire.

The EuroQol five-dimensional (EQ-5D) questionnaire is used worldwide as a patient-reported outcome (PRO) instrument for the measurement and valuation of health. Several variants of the instrument now exist, including versions with three and five levels of severity and one for respondents aged 8 to 14 years. From the outset, a demand for new language versions of the EQ-5D questionnaire meant that there was a need to implement standardized procedures, which ensured that such versions were produced following international recommendations for the cultural adaptation of patient-reported outcomes. The availability of new variants and formats of the instrument, such as telephone-administered or electronic formats, complicated the task of providing and controlling the quality of cultural adaptations. Although cultural adaptations of the instrument are widely used, the procedures currently used to produce them have not been widely disseminated. The present article therefore describes the evolution of the production of other language versions of the instrument from the earliest days of simultaneous production and translation of the EQ-5D questionnaire to the more recent, broader-based strategy of version management. We describe current adaptation procedures and innovations within those procedures. We also describe how version management is organized within the EuroQol Group, review aspects related to quality control, and provide an overview of the number of currently available language versions for each variant of the EQ-5D questionnaire: three-level, five-level, and youth versions. We conclude by discussing some of the relevant issues related to cultural adaptation for frequently used instruments such as the EQ-5D questionnaire.

Measuring health‐related quality of life in MSA: The MSA‐QoL

The objective of this study was to develop a new patient‐reported outcome measure for patients with multiple system atrophy (MSA) and to test its psychometric properties. There were three stages. First, a pool of potential scale items was generated from in‐depth patient interviews. Second, these items were administered, in the form of a questionnaire, to a sample of people with MSA and traditional psychometric methods used to develop a rating scale satisfying standard criteria for reliability and validity. Third, the psychometric properties of the rating scale were examined in a second sample. In stage one, a pool of 105 items was generated from 20 patient interviews. In stage two, a scale with three subscales (motor, 14 items; nonmotor, 12 items; emotional/social functioning, 14 items), satisfying standard criteria for reliability and validity, was developed from the response data of 317 patients with MSA (response rate 71%). In stage three, the scale was examined in 286 people with MSA. Missing data were low, scores in both subscales were evenly distributed, and floor and ceiling effects were small. Reliability was high (Cronbachs alpha 0.83–0.93; test‐retest ICC 0.88–0.92). Validity was supported by the interscale correlations (r = 0.47–0.59), known group differences, and the magnitude and pattern of correlations with four other rating scales, disease severity, and disease duration. In conclusion, the patient‐rated MSA health‐related Quality of life scale (MSA‐QoL) may be a suitable patient‐reported scale for use in clinical trials and studies in MSA.

Evaluation of health status in epilepsy using the EQ-5D questionnaire: a prospective, observational, 6-month study of adjunctive therapy with anti-epileptic drugs

ABSTRACT Aims: The aims of this project were to evaluate the impact of adjunctive treatment with an anti-epileptic drug (AED) on the health status of people with epilepsy and to investigate how seizure frequency affects their health status. Methods: Adult epilepsy patients, refractory to current treatment, were included in this prospective observational study. Patients commencing adjunctive therapy with one of five AEDs (topiramate, lamotrigine, gabapentin, clobazam, vigabatrin) were eligible for inclusion. The study took place at the outpatient clinics of the National Hospital for Neurology and Neurosurgery, Queen Square, London. Patients completed the EQ-5D, a generic health status measure, at baseline and again after 3 and 6 months. Information was also collected on medications and seizure frequency. Results: In total, 125 patients entered the study and were followed up for 6 months. Patients treated with topiramate had a significant increase ( p < 0.05) in EQ-5D score from baseline, indicating an improvement in their health status whereas scores for lamotrigine, clobazam and gabapentin all showed a non-significant decline. When the data were analysed according to seizure frequency, only patients who became seizure-free on adjunctive treatment had a significant increase in their health status. The group who had a 50% reduction in seizure frequency did not have increased health status. Conclusions: In summary, adjunctive treatment with topiramate significantly increased health status as measured by the EQ-5D. These data also suggest that achievement of seizure-freedom is the key to improving health status in this patient group.

The self-report Barthel Index: preliminary validation in people with Parkinson's disease.

Background and purpose:  To make a preliminary assessment of the reliability and validity of the self‐report Barthel Index (SRBI) in people with Parkinson’s (PWP) disease.

Why is it difficult to predict language impairment and outcome in patients with aphasia after stroke

One of the most devastating consequences of stroke is aphasia. Communication problems after stroke can severely impair the patients quality of life and make even simple everyday tasks challenging. Despite intense research in the field of aphasiology, the type of language impairment has not yet been localized and correlated with brain damage, making it difficult to predict the language outcome for stroke patients with aphasia. Our primary objective is to present the available evidence that highlights the difficulties of predicting language impairment after stroke. The different levels of complexity involved in predicting the lesion site from language impairment and ultimately predicting the long-term outcome in stroke patients with aphasia were explored. Future directions and potential implications for research and clinical practice are highlighted.

Long-term follow-up of topiramate and lamotrigine: a perspective on quality of life

We conducted a prospective, long-term audit of lamotrigine and topiramate as add-on treatment for refractory epilepsy. A total of 55 patients participated in the study. Five years after starting the drug 7/20 patients remained on lamotrigine and 13/35 on topiramate. The patients still on the study drugs showed an improvement in seizure frequency, with 5/7 patients being seizure free on lamotrigine and 4/13 on topiramate. Furthermore, we assessed quality of life using the quality of life assessment schedule and found a significant improvement for the patients still on the study drugs. These data suggest that about one third of the patients on lamotrigine or topiramate as add-on therapy stay on the drug in the long term. These patients are likely to benefit with respect to objective and subjective outcome measures.

The use of the NDDI-E in Arabic to identify symptoms of depression of moderate or greater severity in people with epilepsy

AIM The aims of the current study were to translate and to validate the NDDI-E to the Arabic language to be used as a screening instrument to identify moderately severe symptoms of depression in people with epilepsy. METHODS The English version of the NDDI-E was translated to Arabic and back translated to English by two independent translators. A total of 51 patients, aged 18-56years old, with a diagnosis of epilepsy, completed the Arabic versions of the Beck Depression Inventory (BDI-II) and the NDDI-E. Patients with BDI scores >20 were considered to be suffering from moderately severe depressive symptoms. Cutoff scores, sensitivity, specificity, and positive and negative predictive values of the NDDI-E to identify symptomatic patients on the BDI were calculated. RESULTS A sensitivity of 93.33% and a specificity of 94.44% were found with NDDI-E total scores >15. The positive predictive value was 87.5%, and the negative predictive value was 97.14%. Spearmans rank correlation between the BDI and the NDDI-E was high (r=.78, p=0.000, N=51). Internal consistency was at 0.926 (Cronbachs alpha). CONCLUSION The Arabic version of the NDDI-E appears to be a reliable and sensitive instrument in the identification of moderately severe or severe depressive symptoms in people with epilepsy, and it can be used with all Arabic-speaking patients.

Refinement and validation of the Parental Illness Impact Scale

OBJECTIVE To refine and validate the Parental Illness Impact Scale (PIIS), a questionnaire designed specifically to measure the quality of life of adolescent and adult children of neurologically affected parents. METHODS Key informant interviews and a literature review were conducted to ensure all relevant themes were incorporated in the revised PIIS (PIIS-R). Pre-testing was achieved through a 17 member expert panel and cognitive interviews with eight adolescent and adult children. The revised instrument was administered to 169 adolescent and adult children of people with Parkinsons disease, multiple sclerosis and stroke and subjected to psychometric analysis. RESULTS Principal components analysis resulted in eight subscales accounting for 60.6% of explained variance. The PIIS-R showed good concurrent and discriminant validity through correlations with established measures of quality of life and psychosocial well-being. Internal consistency was high (Cronbachs alpha .92), and test-retest reliability values for subscales (r = .59-.74) and total score (r = .79) were moderate to high. CONCLUSIONS The PIIS-R is a scientifically robust measurement tool for assessing the impact of parental illness, and currently shows strong psychometric properties. Longitudinal data will be required to assess predictive validity and sensitivity to change. The instrument is available to other investigators, who are encouraged to further evaluate its scientific properties.