IMPORTANCE Levetiracetam is a commonly used antiepileptic drug, yet psychiatric adverse effects are common and may lead to treatment discontinuation. OBJECTIVE To derive prediction models to estimate the risk of psychiatric adverse effects from levetiracetam use. DESIGN, SETTING, AND PARTICIPANTS Retrospective open cohort study. All patients meeting the case definition for epilepsy after the Acceptable Mortality Reporting date in The Health Improvement Network (THIN) database based in the United Kingdom (inclusive January 1, 2000, to May 31, 2012) who received a first-ever prescription for levetiracetam were included. Of 11 194 182 patients registered in THIN, this study identified 7400 presumed incident cases (66.1 cases per 100 000 persons) over a maximum of 12 years' follow-up. The index date was when patients received their first prescription code for levetiracetam, and follow-up lasted 2 years or until an event, loss to follow-up, or censoring. The analyses were performed on April 22, 2018. EXPOSURE A presumed first-ever prescription for levetiracetam. MAIN OUTCOMES AND MEASURES The outcome of interest was a Read code for any psychiatric sign, symptom, or disorder as reached through consensus by 2 authors. This study used regression techniques to derive 2 prediction models, one for the overall population and one for those without a history of a psychiatric sign, symptom, or disorder during the study period. RESULTS Among 1173 patients with epilepsy receiving levetiracetam, the overall median age was 39 (interquartile range, 25-56) years, and 590 (50.3%) were female. A total of 14.1% (165 of 1173) experienced a psychiatric symptom or disorder within 2 years of index prescription. The odds of reporting a psychiatric symptom were significantly elevated for women (odds ratio [OR], 1.41; 95% CI, 0.99-2.01; P = .05) and those with a preexposure history of higher social deprivation (OR, 1.15; 95% CI, 1.01-1.31; P = .03), depression (OR, 2.20; 95% CI, 1.49-3.24; P < .001), anxiety (OR, 1.74; 95% CI, 1.11-2.72; P = .02), or recreational drug use (OR, 2.02; 95% CI, 1.20-3.37; P = .008). The model performed well after stratified k = 5-fold cross-validation (area under the curve [AUC], 0.68; 95% CI, 0.58-0.79). There was a gradient in risk, with probabilities increasing from 8% for 0 risk factors to 11% to 17% for 1, 17% to 31% for 2, 30% to 42% for 3, and 49% when all risk factors were present. For those free of a preexposure psychiatric code, a second model performed comparably well after k = 5-fold cross-validation (AUC, 0.72; 95% CI, 0.54-0.90). Specificity was maximized using threshold cutoffs of 0.10 (full model) and 0.14 (second model); a score below these thresholds indicates safety of prescription. CONCLUSIONS AND RELEVANCE This study derived 2 simple models that predict the risk of a psychiatric adverse effect from levetiracetam. These algorithms can be used to guide prescription in clinical practice.

SUMMARYPurpose: (1) To determine whether health resource utilization (HRU) and unmet health care needs differ for individuals with epilepsy compared to the general population or to those with another chronic condition (asthma, diabetes, migraine); and (2) to assess the association among epilepsy status, sociodemographic variables and HRU. Methods: Data on HRU were assessed using the 2001-2005 Canadian Community Health Surveys, a nationally representative population-based survey. Weighted estimates of association were produced as adjusted odds ratio with 95% confidence intervals, and logistic regression was used to explore the association between sociodemographic variables and HRU in those with epilepsy. All data on disease status, HRU, and unmet health care needs were self-reported. Key Findings: Individuals with epilepsy had the highest rate of hospitalizations and the highest mean number of consultations with physicians. Despite higher rates of consultation with psychologists and social workers compared to the general population, those with epilepsy were significantly more likely to say they had unmet mental health care needs. People with epilepsy were also less likely to use dental services compared to the general population. Epilepsy was a significant predictor of HRU in logistic regression models. Significance: Given the prevalence of psychiatric comorbidities in those with epilepsy, it is concerning that this group perceives unmet mental health care needs. It is also troublesome that there was decreased utilization of dental health care resources in those with epilepsy considering that these patients are more likely to have poor oral health. Although individuals with epilepsy use more health care services than the general population, this increase appears to be insufficient to address their health care needs.

This study demonstrates that there is a great deal of variation in the reporting of quality and safety measures and in the quality and safety in EMUs. Study quality also varied considerably from one study to the next. These findings highlight the need to develop evidence-based, consensus-driven quality indicators for EMUs.

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