SUMMARYObjective: Evaluate the seizure-reduction response and safety of mesial temporal lobe (MTL) brain-responsive stimulation in adults with medically intractable partial-onset seizures of mesial temporal lobe origin. Methods: Subjects with mesial temporal lobe epilepsy (MTLE) were identified from prospective clinical trials of a brain-responsive neurostimulator (RNS System, NeuroPace). The seizure reduction over years 2-6 postimplantation was calculated by assessing the seizure frequency compared to a preimplantation baseline. Safety was assessed based on reported adverse events. Results: There were 111 subjects with MTLE; 72% of subjects had bilateral MTL onsets and 28% had unilateral onsets. Subjects had one to four leads placed; only two leads could be connected to the device. Seventy-six subjects had depth leads only, 29 had both depth and strip leads, and 6 had only strip leads. The mean follow-up was 6.1 AE (standard deviation) 2.2 years. The median percent seizure reduction was 70% (last observation carried forward). Twenty-nine percent of subjects experienced at least one seizure-free period of 6 months or longer, and 15% experienced at least one seizure-free period of 1 year or longer. There was no difference in seizure reduction in subjects with and without mesial temporal sclerosis (MTS), bilateral MTL onsets, prior resection, prior intracranial monitoring, and prior vagus nerve stimulation. In addition, seizure reduction was not dependent on the location of depth leads relative to the hippocampus. The most frequent serious device-related adverse event was soft tissue implant-site infection (overall rate, including events categorized as device-related, uncertain, or not device-related: 0.03 per implant year, which is not greater than with other neurostimulation devices). Significance: Brain-responsive stimulation represents a safe and effective treatment option for patients with medically intractable epilepsy, including patients with unilateral or bilateral MTLE who are not candidates for temporal lobectomy or who have failed a prior MTL resection.

BackgroundThe QUALICOPC (Quality and Costs of Primary Care in Europe) study aims to evaluate the performance of primary care systems in Europe in terms of quality, equity and costs. The study will provide an answer to the question what strong primary care systems entail and which effects primary care systems have on the performance of health care systems. QUALICOPC is funded by the European Commission under the "Seventh Framework Programme". In this article the background and design of the QUALICOPC study is described.Methods/designQUALICOPC started in 2010 and will run until 2013. Data will be collected in 31 European countries (27 EU countries, Iceland, Norway, Switzerland and Turkey) and in Australia, Israel and New Zealand. This study uses a three level approach of data collection: the system, practice and patient. Surveys will be held among general practitioners (GPs) and their patients, providing evidence at the process and outcome level of primary care. These surveys aim to gain insight in the professional behaviour of GPs and the expectations and actions of their patients. An important aspect of this study is that each patient's questionnaire can be linked to their own GP's questionnaire. To gather data at the structure or national level, the study will use existing data sources such as the System of Health Accounts and the Primary Health Care Activity Monitor Europe (PHAMEU) database. Analyses of the data will be performed using multilevel models.DiscussionBy its design, in which different data sources are combined for comprehensive analyses, QUALICOPC will advance the state of the art in primary care research and contribute to the discussion on the merit of strengthening primary care systems and to evidence based health policy development.

Available evidence suggests that strong primary care in terms of adequate primary care physician supply and long-term relationships between primary care physicians and patients reduces hospitalizations for chronic ACSCs. There is a lack of evidence for the positive effects of many other organizational primary care aspects, such as specific disease management programs.