Drug Use Study With Intuniv® in Australia

Study Overview
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Brief Summary
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This study will evaluate and analyze prescribing behaviors of physicians and determine whether Intuniv was correctly prescribed in Australia.

Detailed Description
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This is a drug utilization study using retrospective database analysis where study will combine data from two sources of patient-level drug utilization data for Intuniv: i) NostraData database: longitudinal participant level prescription database ii) Physician survey: de-identified participant data provided by representative physicians in Australia In the NostraData database, actual prescription data are collected, which allows generation of information on drug usage. However, these prescription data do not contain patient variables such as age and indication needed to monitor potential off-label use. Therefore, these data must be supplemented with another data source. The physician survey will provide the data not included in the NostraData database.

Official Title
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Drug Utilization Study With Intuniv® in Australia

Conditions
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Attention Deficit Hyperactivity Disorder (ADHD)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is indicated for the treatment of ADHD in children and adolescents 6 to 17 years old, as monotherapy. Must be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures. Exclusion Criteria: Use for participants with a diagnosis other than ADHD. Use for children less than 6 years of age. Use in adults (greater than or equal to [>=] 18 years of age) Prescribed overdose greater than (>) 7 milligram per day (mg/day) for participants > 12 years, or > 4 mg/ day for children lesser than or equal to (<=) 12 years. If monotherapy with Intuniv, no prior treatment with stimulants or atomoxetine.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 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 |
| --- | --- |
| NostraData Database<br>All prescriptions for Intuniv available in the NostraData database in Austrialia will be analyzed in this study. | |
| Physician Survey<br>Physician will collect medical record data of 100 participants who have been prescribed Intuniv at least once during the study period to treat participants with ADHD. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Based on Indication of Use of Intuniv | Number of Participants Based on Indication of Use of Intuniv will be assessed. | Up to 3 years | 
| Number of Participants with Presence/Absence of Contraindications | Number of participants with presence/absence of contraindications will be assessed. | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Based on Patterns of Drug Use | Patterns of drug use will include daily dose, first time user, repeat user, treatment duration, treatment gaps, discontinuation of ADHD therapy and switch of therapy, co-prescriptions of ADHD medication. | Up to 3 years | 
| Number of Participants Stratified by Prescriber Information Based on Physician Survey | Participants will be stratified based on prescriber information which include specialty, graduation year, gender, location, and region. | Up to 3 years | 
| Frequency of Weight Monitoring of Participants by Physician | Frequency of weight monitoring of participants by physician will be reported. | Up to 3 years | 
| Frequency of Blood Pressure Monitoring of Participants by Physician | Frequency of blood pressure monitoring of participants by physician will be reported. | Up to 3 years | 
| Frequency of Heart Rate Monitoring of Participants by Physician | Frequency of heart rate monitoring of participants by physician will be reported. | Up to 3 years |