Drug Utilisation Study of Intuniv® (Guanfacine Extended Release) in European Countries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Number of Participants Stratified by Prescriber Information Based on Physician Survey
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Physicians who do not treat participants or who may have a conflict of interest (i.e. physicians employed by regulatory bodies or pharmaceutical industries).
结局指标
主要结局
Number of Participants Stratified by Prescriber Information Based on Physician Survey
时间窗: Up to 4 years
Participants will be stratified based on prescriber information which include demographics, specialty, and setting of prescriber.
Number of Participants Using Intuniv® as Second Line Treatment After Psychostimulant Prescription at any Time Prior to the Participant's First Prescription of Intuniv®
时间窗: Up to 4 years
Number of Participants Categorised Based on Their Demographic Characteristics
时间窗: Up to 4 years
The demographic characteristics will include age and gender.
Number of Participants with Co-morbidities
时间窗: Up to 4 years
Number of Participants With ADHD Categorised Based on Different Patterns of Intuniv® Use
时间窗: Up to 4 years
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).
Number of Participants Based on Indication of Use of Prescribed Intuniv®
时间窗: Up to 4 years
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.
次要结局
- Number of Physician Visits During the First Year of Therapy(Up to 4 years)
- Frequency of Weight Monitoring of Participants by Physician(Up to 4 years)
- Frequency of Heart Rate Monitoring of Participants by Physician(Up to 4 years)
- Frequency of Blood Pressure Monitoring of Participants by Physician(Up to 4 years)