Physician Survey to Assess Effectiveness of Strattera Risk Minimisation Activities in Prescribers Treating Adult Patients with ADHD

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Survey

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N06BA09) atomoxetine

  atomoxetine

Population studied

• Short description of the study population:
  Psychiatrists who prescribe Strattera and/or monitor adult patients treated with Strattera in Denmark, Sweden, the Netherlands, Spain, and the UK.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  250

Study design details

• Main study objective:
  The main objective of this a survey is to assess the knowledge and awareness of Strattera risk minimisation measures among psychiatrists who prescribe Strattera or monitor adult patients treated with Strattera. The secondary objective includes an assessment of awareness of the available risk minimisation tools.
• Outcomes:
  Awareness, knowledge and adherence will be evaluated and expressed as proportions
• Data analysis plan:
  Data analyses will be descriptive and will entail tabular displays of mean values and the frequency distribution of item responses. Results will be expressed as proportions and means. Summary tables will include descriptive statistics for continuous variables (means) and categorical variables (frequencies, percentages). Results will be analyzed on an item-by-item or variable-by-variable basis. These descriptive statistics will allow for the assessment of how rates vary for each of the items evaluated. No formal hypothesis testing will be conducted. The risk minimisation activities will be considered successful if a majority of psychatrists participating in the survey are aware of and prescribe Strattera in accordance with the cardiovascular/cerebrovascular contraindications, warnings and precautions and the recommendation to monitor blood pressure and heart rate in all patients at baseline and during treatment with Strattera.

Documents

Study results

B028 PASS FSR

Study, other information

B028 RMiP PASS Protocol_2