Drug Use Study With Intuniv® in European Countries

Study Overview
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Brief Summary
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This study will evaluate and characterize people who are taking Intuniv, analyze prescribing behaviors of physicians, and determine whether Intuniv was correctly prescribed in Belgium, Denmark, Finland, Germany, Ireland, Netherlands, Norway, Spain, Sweden, and the United Kingdom.

Detailed Description
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The study aims to characterize participants who are prescribed Intuniv® and describe prescribing patterns of Intuniv® among physicians in European countries. This study will collect data from the following sources: Physician Survey: de-identified patient data provided by representative physicians in Belgium, Finland, Ireland, and the Netherlands, with a goal of data from up to 100 participants per survey wave. Database Survey: longitudinal patient-level prescription database in all other countries with data on approximately 5000 participants. In the database study, actual prescription data are collected from electronic medical records and national registries. A prescriber survey will be conducted to evaluate health care professionals (HCPs) real-life practice. It will include data collection from the prescriber's (physician's) files and a web questionnaire, including de-identified data from up to 100 participants per survey wave.

Official Title
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Drug Utilisation Study of Intuniv® (Guanfacine Extended Release) in European Countries

Conditions
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Attention Deficit Hyperactivity Disorder (ADHD)

Intervention / Treatment
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* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prescribers of Intuniv®, i.e. physicians who know and have prescribed the drug at least once during the previous 12 months (or, for the first report, since country specific launch) (paediatricians, psychiatrists, neurologists and GPs). Participants who have been prescribed Intuniv® at least once during the reporting period. Exclusion Criteria: • Physicians who do not treat participants or who may have a conflict of interest (i.e. physicians employed by regulatory bodies or pharmaceutical industries).

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Database Survey<br>All prescriptions for Intuniv available in the database in Denmark, Germany, Norway, Spain, Sweden, and the United Kingdom will be analyzed. | Other: No Intervention<br>* This is an observational study utilizing historical de-identified patient level data; therefore no intervention is given.<br>|
| Physician Survey<br>The physicians will collect participant records of those who have been prescribed Intuniv® at least once during the study period of 4 years. This will be done in Belgium, Finland, Ireland, and the Netherlands. | Other: No Intervention<br>* This is an observational study utilizing historical de-identified patient level data; therefore no intervention is given.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Stratified by Prescriber Information Based on Physician Survey | Participants will be stratified based on prescriber information which include demographics, specialty, and setting of prescriber. | Up to 4 years | 
| Number of Participants Categorised Based on Their Demographic Characteristics | The demographic characteristics will include age and gender. | Up to 4 years | 
| Number of Participants with Co-morbidities |  | Up to 4 years | 
| Number of Participants Based on Indication of Use of Prescribed Intuniv® | Indication of use (diagnosis) will be assessed as per World Health Organization (WHO) 10th International Statistical Classification of Diseases and Related Health Problems (ICD) classification. | Up to 4 years | 
| Number of Participants With ADHD Categorised Based on Different Patterns of Intuniv® Use | Patterns of drug use include first time users, repeat users, participants who discontinued the ADHD therapy, participants with switches in treatment (both from Intuniv® to other ADHD medications and other ADHD medications to Intuniv®), and participants with dosing/overdose (defined as daily dose of >7 mg or of >4mg in participants ≤12 years of age). | Up to 4 years | 
| Number of Participants Using Intuniv® as Second Line Treatment After Psychostimulant Prescription at any Time Prior to the Participant's First Prescription of Intuniv® |  | Up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Physician Visits During the First Year of Therapy |  | Up to 4 years | 
| Frequency of Weight Monitoring of Participants by Physician | Frequency of weight monitoring of participants by physician will be reported. | Up to 4 years | 
| Frequency of Blood Pressure Monitoring of Participants by Physician | Frequency of blood pressure monitoring of participants by physician will be reported. | Up to 4 years | 
| Frequency of Heart Rate Monitoring of Participants by Physician | Frequency of heart rate monitoring of participants by physician will be reported. | Up to 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy