Rafael Mikolajczyk1, Johannes Horn2, Niklas Schmedt3, Ingo Langner3, Christina Lindemann4, Edeltraut Garbe5. 1. Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology-BIPS GmbH, Bremen, Germany2Epidemiological and Statistical Methods Research Group, Helmholtz Centre for Infection Research, Braunschweig, Germany3Department of. 2. Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology-BIPS GmbH, Bremen, Germany2Epidemiological and Statistical Methods Research Group, Helmholtz Centre for Infection Research, Braunschweig, Germany. 3. Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology-BIPS GmbH, Bremen, Germany. 4. Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology-BIPS GmbH, Bremen, Germany3Department of Infectious Diseases Epidemiology, Hannover Medical School, Hannover, Germany. 5. Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology-BIPS GmbH, Bremen, Germany4Faculty of Human and Social Sciences, University of Bremen, Bremen, Germany.
Abstract
IMPORTANCE: Children and adolescents with attention-deficit/hyperactivity disorder (ADHD) have an increased risk of injuries. Attention-deficit/hyperactivity disorder is often treated with medication, but the evidence regarding prevention of injuries is inconclusive. OBJECTIVE: To determine via a case-only design whether the use of methylphenidate hydrochloride or atomoxetine hydrochloride reduces the risk of injuries among children and adolescents with ADHD. DESIGN, SETTING, AND PARTICIPANTS: We used the German Pharmacoepidemiological Research Database, which includes records from about 17 million insurees (approximately 20% of the population) from 4 statutory health insurance providers in Germany to identify children aged 3 to 17 years with new diagnoses of ADHD in 2005 and 2006. We identified 37,650 children with ADHD based on inpatient and outpatientdiagnostic codes (F90.0, F90.1, and F90.9) from the German modification of the International Statistical Classification of Diseases and Related Health Problems, 10th Revision. Among them, we identified those with an inpatient injury diagnosis during follow-up until 2009. A total of 2128 children with any injury diagnosis at hospitalization, 821 of whom had a brain injury diagnosis, were included in the analysis. We applied the self-controlled case series design to control for time-invariant characteristics of the patients and time trends in the exposure. EXPOSURES: Treatment with methylphenidate or atomoxetine based on prescription data. MAIN OUTCOMES AND MEASURES: Hospitalization because of any injury or brain injury according to the injury mortality diagnosis matrix. RESULTS: Incidence rate ratios for the periods with medication compared with nonmedicated periods were 0.87 (95% CI, 0.74-1.02) for hospitalization with any injuries and 0.66 (95% CI, 0.48-0.91) for brain injuries only in the full sample. These estimates remained stable in sensitivity analyses restricting the sample to a narrower age range or to patients with a single hospitalization. There was no indication that medication prescriptions are increased after hospitalizations. CONCLUSIONS AND RELEVANCE: No significant risk reduction for hospitalizations with injury diagnoses was observed during periods of ADHD medication, but there was a preventive effect on the risk of brain injuries (34% risk reduction). The effects were controlled for time-invariant characteristics of the patients by the study design.
IMPORTANCE: Children and adolescents with attention-deficit/hyperactivity disorder (ADHD) have an increased risk of injuries. Attention-deficit/hyperactivity disorder is often treated with medication, but the evidence regarding prevention of injuries is inconclusive. OBJECTIVE: To determine via a case-only design whether the use of methylphenidate hydrochloride or atomoxetine hydrochloride reduces the risk of injuries among children and adolescents with ADHD. DESIGN, SETTING, AND PARTICIPANTS: We used the German Pharmacoepidemiological Research Database, which includes records from about 17 million insurees (approximately 20% of the population) from 4 statutory health insurance providers in Germany to identify children aged 3 to 17 years with new diagnoses of ADHD in 2005 and 2006. We identified 37,650 children with ADHD based on inpatient and outpatientdiagnostic codes (F90.0, F90.1, and F90.9) from the German modification of the International Statistical Classification of Diseases and Related Health Problems, 10th Revision. Among them, we identified those with an inpatient injury diagnosis during follow-up until 2009. A total of 2128 children with any injury diagnosis at hospitalization, 821 of whom had a brain injury diagnosis, were included in the analysis. We applied the self-controlled case series design to control for time-invariant characteristics of the patients and time trends in the exposure. EXPOSURES: Treatment with methylphenidate or atomoxetine based on prescription data. MAIN OUTCOMES AND MEASURES: Hospitalization because of any injury or brain injury according to the injury mortality diagnosis matrix. RESULTS: Incidence rate ratios for the periods with medication compared with nonmedicated periods were 0.87 (95% CI, 0.74-1.02) for hospitalization with any injuries and 0.66 (95% CI, 0.48-0.91) for brain injuries only in the full sample. These estimates remained stable in sensitivity analyses restricting the sample to a narrower age range or to patients with a single hospitalization. There was no indication that medication prescriptions are increased after hospitalizations. CONCLUSIONS AND RELEVANCE: No significant risk reduction for hospitalizations with injury diagnoses was observed during periods of ADHD medication, but there was a preventive effect on the risk of brain injuries (34% risk reduction). The effects were controlled for time-invariant characteristics of the patients by the study design.
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