Attention Deficit Hyperactivity Disorder (ADHD)
Conditions
Brief summary
This study will evaluate and analyze prescribing behaviors of physicians and determine whether Intuniv was correctly prescribed in Australia.
Detailed description
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.
Interventions
None listed
Sponsors
Shire
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Based on Indication of Use of Intuniv | Up to 3 years | Number of Participants Based on Indication of Use of Intuniv will be assessed. |
| Number of Participants with Presence/Absence of Contraindications | Up to 3 years | Number of participants with presence/absence of contraindications will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Weight Monitoring of Participants by Physician | Up to 3 years | Frequency of weight monitoring of participants by physician will be reported. |
| Number of Participants Based on Patterns of Drug Use | Up to 3 years | 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. |
| Frequency of Heart Rate Monitoring of Participants by Physician | Up to 3 years | Frequency of heart rate monitoring of participants by physician will be reported. |
| Frequency of Blood Pressure Monitoring of Participants by Physician | Up to 3 years | Frequency of blood pressure monitoring of participants by physician will be reported. |
| Number of Participants Stratified by Prescriber Information Based on Physician Survey | Up to 3 years | Participants will be stratified based on prescriber information which include specialty, graduation year, gender, location, and region. |
Countries
Australia
Outcome results
None listed