Health-related quality of life in double-blind Phase III studies of brivaracetam as adjunctive therapy of focal seizures: A pooled, post-hoc analysis.

PURPOSE: The effect of adjunctive brivaracetam on health-related quality of life (HRQoL) was assessed in a post-hoc analysis using pooled data from three randomized, double-blind, placebo-controlled Phase III studies in patients with refractory focal seizures (NCT00490035, NCT00464269, and NCT01261325). METHODS: The Patient-Weighted Quality of Life in Epilepsy Questionnaire (QOLIE-31-P) was completed at randomization, and weeks 4, 8 (in two of three studies), and 12 (end of the treatment period). Mean change from baseline to week 12 or early discontinuation, and percentage of patients with clinically meaningful improvement were reported for the placebo and brivaracetam 50, 100, and 200mg/day groups. RESULTS: At baseline, mean QOLIE-31-P scores were similar between treatment groups. At week 12 or early discontinuation, mean (standard deviation) changes from baseline in QOLIE-31-P total score were 2.8 (12.7), 3.0 (14.0), 2.4 (14.0), and 3.0 (12.1) points for the placebo and brivaracetam 50, 100, and 200mg/day groups, respectively, indicating HRQoL improved slightly over time during the treatment period, but was similar for placebo and brivaracetam groups. All subscale score changes were positive, indicating stable or improved HRQoL over time. The brivaracetam 100 and 200mg/day groups showed the largest differences compared with placebo in Seizure Worry subscale scores (7.3 and 8.8 vs. 5.0 points). Approximately 40% of patients had improvements in QOLIE-31-P scores beyond the Minimal Important Change (MIC) thresholds. The subgroup of ≥50% focal seizure frequency responders had higher improvements for all treatment arms and all subscales than for those in the overall pooled population. CONCLUSION: In this post-hoc analysis, adjunctive brivaracetam treatment was shown to be associated with stable or improving overall HRQoL over time, similar to placebo, with modest improvements in subscales sensitive to efficacy, and no deterioration in subscales sensitive to tolerability. These results reflect the known efficacy and tolerability profile of brivaracetam.

PatientsLikeMe® Online Epilepsy Community: Patient characteristics and predictors of poor health-related quality of life.

OBJECTIVE: The online PatientsLikeMe® Epilepsy Community allows patients with epilepsy to record, monitor, and share their demographic, disease, and treatment characteristics, providing valuable insights into patient perceptions and understanding of epilepsy. The objective of this retrospective analysis was to characterize the profile of users and their disease and identify factors predictive of poor health-related quality of life (HRQoL), while assessing the platform's potential in providing patient-reported data for research purposes. METHODS: Data recorded (January 2010-November 2011) by Epilepsy Community members, with an epilepsy diagnosis and who reported >1 seizure, included the following: sociodemographic and disease characteristics, treatments, symptoms, side effects perceived as medication-related, seizure occurrence, and standardized questionnaires (Quality of Life in Epilepsy Inventory [QOLIE-31/P], EuroQoL 5-Dimensions Scale, 3 Levels [EQ-5D-3L], and Hospital Anxiety and Depression Scale [HADS]). Univariate and multivariate logistic regressions were conducted to identify predictors of poor HRQoL. RESULTS: During the study period, the Epilepsy Community comprised 3073 patients, of whom 71.5% were female, had a mean age of 37.8years, and had a mean epilepsy duration of 17.7years. The most frequently reported moderate/severe symptoms (n=2135) included memory problems (60.2%), problems concentrating (53.8%), and fatigue (50.0%). Medication-related side effects (n=639) included somnolence (23.2%), fatigue (17.2%), and memory impairment (13.8%). The QOLIE-31/P scores (n=1121) were significantly worse in patients who experienced a recent seizure. For QOLIE-31/P, highly predictive factors for poor HRQoL included the following: mild/moderate problems concentrating, depression, memory problems, treatment side effects, occurrence of tonic-clonic seizures, and epilepsy duration ≤1year. For EQ-5D-3L, highly predictive factors for poor HRQoL included the following: pain, depression, and comorbidities. Patients on newer AEDs were less likely to report poor HRQoL (QOLIE-31/P). SIGNIFICANCE: These findings move further towards supporting the feasibility and usefulness of collecting real-world, anonymized data recorded by patients online. The data provide insights into factors impacting HRQoL, suggesting that a holistic treatment approach beyond seizure control should be considered in epilepsy.

A computer-based information-tool for chronic pain patients. Computerized information to support the process of shared decision-making.

OBJECTIVE: Assessment of the use of a computerized information-tool in the context of a shared decision-making process with chronic pain patients. METHODS: In the scope of a prospective and randomized study on shared decision-making with Fibromyalgia patients, a total of 75 patients had access to computer-based information about their illness. Fibromyalgia is a condition of chronic wide-spread pain, belonging to rheumatism, which mainly affects mature female patients. The majority of the patients in our study are female (93%) with an average age of 50 years. The computer-based information-tool provided the patients with detailed information about pathogenesis, typical symptoms, treatment options and prognosis. Six evaluative questions were posed to the participants concerning the assessment of the information presented, the handling of the programme, the need for an introduction to the programme, the quality of the layout and the assessment of the length of time spent in front of the computer and the assessment of the usefulness of such a tool in general practitioners' offices. Furthermore, psychological self-assessment questionnaires were filled out by the participants. RESULTS: The patients highly appreciate the possibility of using computer-based information-tools and endorse the implementation of such tools in general practitioners' offices. CONCLUSION: Computerized information leads to a better understanding of the illness and the treatment options on the part of the patient. PRACTICAL IMPLICATIONS: For further practical use it is crucial to provide an introduction to the handling of a computer to unskilled patients.

Improvement of the educational process by computer-based visualization of procedures: randomized controlled trial.

BACKGROUND: Before any invasive procedure, physicians have a legal obligation to inform patients. Traditionally, this involves a discussion with a physician, supplemented by written leaflet information directed at the specific procedure. OBJECTIVE: Comparison of the use and effectiveness of computer-based visualization opposed to standardized conversation for providing patients with information of forthcoming procedures (coronary catheters or endoscopy procedures). METHODS: Prospective, randomized trial with 56 participants allocated in two different groups: Visualization Group (standardized information supported by a tool for displaying two-dimensional pictures to explain medical facts as well as informative leaflet) or Control Group (standardized information and informative leaflet only). Detailed information was given about the indication, the probable complications and the details of the forthcoming procedures (coronary catheters or endoscopy procedures). All participants had to reach a Karnofsky Score of 70 points and be able to understand German or English. Main outcome measures were patient's satisfaction with physician-patient conversation, patient's acquired knowledge and duration of the intervention as described above. RESULTS: Patients of the Visualization Group were more satisfied with the conversation and had higher knowledge scores after the conversation. A Mann-Whitney-U-Test between the two groups showed that these differences in satisfaction (P<0.001) and knowledge (P= or <0.006) were statistically significant. Length of time needed for the conversation was slightly higher in the Visualization Group, but this difference was not statistically significant (25 versus 23 min; P= 0.441). No differences could be found due to differing age or educational level in the results of the Visualization and the Control Group. CONCLUSIONS: Using computerized visualization increased the satisfaction and knowledge of the patients. The presentation of the visualized information in the Visualization Group did not demand significantly more time than the standard conversation in the Control Group.

Validation of the arthritis self-efficacy short-form scale in German fibromyalgia patients.

Self-efficacy is assumed to account for significant variance in the treatment outcome of chronic pain patients. The aim of this study was to provide a German version of an approved measure of disease-related self-efficacy in fibromyalgia (FM) patients which assesses treatment outcomes and specific differences compared to other pain patients. The 8-item short-form of the arthritis self-efficacy scale was translated into German (ASES-D) and administered to 148 FM patients and 53 patients with rheumatoid arthritis (RA). In addition, similar cognitive constructs (locus of control, optimism/pessimism, and general self-efficacy) and disease-related variables (pain, functioning, depression, and coping) were assessed. The instrument was further applied to 43 FM patients who underwent interdisciplinary group therapy. Validation methods consisted of correlation, principal component analysis and difference testing between the disease groups. The instrument met good psychometric properties. Evidence for construct validity was provided. Self-efficacy was sensitive to changes and could be used in predicting the treatment outcome in FM patients. The German short-form ASES-D is a further step toward an internationally comparable assessment of disease-related self-efficacy in FM.