Assessment of Quality of Life 8-Dimension (AQoL-8D): translation, validation, and application in two Dutch trials in patients with epilepsy and schizophrenia.

BACKGROUND: To translate and linguistically validate the Assessment of Quality of Life 8-dimensions (AQoL-8D) for use in the Netherlands and to compare the psychometric properties of AQoL-8D with the EuroQol 5-dimensions 5-levels (EQ-5D-5L) in two patient samples. METHODS: AQoL-8D was translated from English into Dutch. The translated AQoL-8D was then administered alongside the EQ-5D-5L at baseline and follow-up of two Dutch randomized controlled trials among patients with epilepsy and schizophrenia. These data were subjected to a post-hoc analysis assessing the psychometric properties of AQol-8D vis-à-vis EQ-5D-5L in terms of known-groups construct validity, responsiveness, and floor/ceiling effects. RESULTS: In total, 103 epilepsy patients and 99 schizophrenia patients were included in this study. In both datasets, the two instruments discriminated between known-groups, but in schizophrenia, AQoL-8D showed higher responsiveness than EQ-5D-5L, while both instruments showed equal responsiveness in epilepsy. Ceiling effects were only found for EQ-5D-5L in both epilepsy (26.6%) and schizophrenia (6.1%). CONCLUSION: Our results have shown that, among other things, AQoL-8D presents better ability to discriminate between known-groups and shows no ceiling effect. Based on our results, we would recommend the use of AQoL-8D in addition to EQ-5D-5L in trials assessing patient's quality of life in patients with epilepsy or schizophrenia.

Effectiveness of a multicomponent self-management intervention for adults with epilepsy (ZMILE study): A randomized controlled trial.

BACKGROUND: The objective of the ZMILE study was to compare the effectiveness of a multicomponent self-management intervention (MCI) with care as usual (CAU) in adult patients with epilepsy (PWE) over a six-month period. METHODS: Participants (PWE & relative) were randomized into intervention or CAU groups. Self-report questionnaires were used to measure disease-specific self-efficacy as the primary outcome measure and general self-efficacy, adherence, seizure severity, emotional functioning, quality of life, proactive coping, and side-effects of antiepileptic drugs (AED) as secondary outcome measures. Instruments used at baseline and during a six-month follow-up period were the following: disease-specific self-efficacy (Epilepsy Self-Efficacy Scale [ESES], General Self-Efficacy Scale [GSES]); adherence (Medication Adherence Scale [MARS] and Medication Event Monitoring System [MEMS]); seizure severity (National Hospital Seizure Severity Scale [NHS3]); emotional well-being (Hospital Anxiety and Depression Scale [HADS]); quality of life (Quality of Life in Epilepsy [QOLIE-31P]); proactive coping (Utrecht Proactive Coping Competence [UPCC]); and side-effects of antiepileptic drugs [SIDAED]. Multilevel analyses were performed, and baseline differences were corrected by inclusion of covariates in the analyses. RESULTS: In total, 102 PWE were included in the study, 52 of whom were in the intervention group. On the SIDAED and on three of the quality of life subscales QOLIE-31P, a significant difference was found (p<0.05) in the intervention group. Self-efficacy, however, showed no significant differences between the MCI and the CAU groups. None of the other outcome measures showed any significant difference between the two groups. SIGNIFICANCE: Although we found no statistically significant difference in the primary outcome measure, disease-specific self-efficacy, this MCI could prove promising, since we found improvement in some domains of quality of life in epilepsy scale and a decrease in AED side-effects in the MCI group compared with the CAU group.

Process evaluation of a multi-component self-management intervention for adults with epilepsy (ZMILE study).

BACKGROUND: People with epilepsy need to monitor and manage their symptoms. They, as well as their relatives, have to deal with the psychological burden, reflected in a reduced quality of life. Support in self-management can be of importance. We have developed a multi-component self-management intervention for patients and their relatives (MCI). This eight-week group intervention is conducted by nurse practitioners and consists of six two-hour sessions. The main components are: 1) providing self-management education, 2) stimulating proactive coping and goal-setting and 3) facilitating peer and social support. This study is a process evaluation to establish the feasibility, fidelity and acceptability of the intervention by assessing performance according to protocol, attendance and adherence, and the opinion of patients, relatives and facilitators about the intervention. METHOD: Study population consists of 52 patients with epilepsy living in the community (e.g. at home), 37 relatives and six facilitators. In this prospective mixed methods study, data were gathered using questionnaires for patients and relatives, registration forms for facilitators and by carrying out semi-structured group interviews with patients, relatives and facilitators. RESULTS: Patients and relatives attended a mean of 5.2 sessions. Forty-seven (90%) patients and 32 (86.5%) relatives attended at least five sessions. The mean group size was 8.1 (SD=1.3; range 6-10). All elements of the intervention were offered to participants, except for one e-Health tool which was only available at the start of the study. Overall, the sessions were considered useful by patients, their relatives and facilitators. The participation of a relative (social support) and sharing ideas and feelings about having epilepsy with peers (peer support) were rated as important aspects. CONCLUSION: This process evaluation revealed that the MCI was largely performed according to protocol, attendance rate was high, and participants and facilitators had, on the whole, a favourable opinion about the MCI, and would recommend it to others with epilepsy and their relatives. Overall, the adherence of patients and relatives was high. The MCI is considered feasible according to patients, relatives and facilitators. Implementation is recommended if the intervention proves to be effective.

An economic evaluation of a multicomponent self-management intervention for adults with epilepsy (ZMILE study).

OBJECTIVE: The objective of this (trial-based) economic evaluation was, from a societal perspective, to compare the cost-effectiveness of a multicomponent self-management intervention (MCI) with care as usual (CAU) in adult patients with epilepsy over a 12-month period. METHODS: In a randomized-controlled trial, participants were randomized into intervention or CAU group. Adherence, self-efficacy (Epilepsy Self-Efficacy Scale [ESES]), quality-adjusted life years (QALYs), healthcare costs, production losses, and patient and family costs were assessed at baseline and during the 12-month study period. Incremental cost-effectiveness ratios (ICERs) (i.e., cost per increased adherence, self-efficacy, or QALY), and cost-effectiveness acceptability curves were calculated. RESULTS: In total, 102 patients were included in the study, of whom 52 were in the intervention group. Adherence rates over 6 months were 63.7% for the CAU group and 75.9% for the intervention group. Adherence, ESES, and quality of life did not differ significantly between groups. An ICER of €54 per point increase in ESES score at 6 months and €1,105 per point increase at 12-month follow-up was found. The intervention resulted in an ICER of €88 per percentage of adherence increase at 6 months. ICERs of €8,272 and €15,144 per QALY gained were found at 6- and 12-month follow-up, respectively. SIGNIFICANCE: Although no statistically significant difference was found after baseline adjustments, cost-effectiveness estimates for MCI appear promising. As rules of inference are arbitrary, it has been argued that decisions should be based only on the net benefits, irrespective of whether differences are statistically significant. Hence, the MCI may be a cost-effective addition to the current standard care for adults with epilepsy.

Are people with epilepsy using eHealth-tools?

INTRODUCTION: Self-management for people with epilepsy (PWE) should lead to shared decision-making and thus to adherence to the treatment plan. eHealth is an important way of supporting PWE in their self-management. METHOD: In this survey, we used a mixed method to explore the following: 1) which factors were monitored by PWE and how (using pen and paper or eHealth-tools), 2) how many PWE own a computer or smartphone, and 3) how do they perceive the use of eHealth. A consecutive series of 1000 PWE attending the outpatient clinic of a tertiary epilepsy center were asked to fill in a questionnaire. RESULTS: In comparison with the general population, fewer PWE owned a computer or smartphone. They were, however, more likely to self-monitor their health than other patients suffering from a chronic condition. Although PWE did not use eHealth-tools often, they perceived it as a user-friendly tool, promoting health behavior as well as adherence. On the other hand, problems with privacy and the perception that not everyone is able to use eHealth were considered as disadvantages by PWE. Promoting self-care was perceived as both an advantage and a disadvantage. It was seen as an advantage when PWE mentioned the option of eHealth-tools in order to gain insight into one's epilepsy. At the same time, it was seen as a disadvantage because it confronts PWE with their disease, which causes emotional stress. CONCLUSION: The high level of self-monitoring combined with a low usage of eHealth-tools seems to indicate that there is a need for a more tailored approach to stimulate the use of eHealth-tools by PWE. Further research should focus on this aspect, e.g., what PWE need in order to make more use of eHealth-tools in their self-care.