Evaluation of the Effectiveness of Risk Minimisation Measures: A Joint PASS Survey and Drug Utilisation Study among Health Care Professionals to Assess their Knowledge and Attitudes on Prescribing Conditions of valproate in France, Germany, Spain, Sweden and United Kingdom

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Other
• If ‘other’, further details on the scope of the study:
  Survey
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  SODIUM VALPROATE

  VALPROATE SEMISODIUM

  VALPROIC ACID

  VALPROMIDE
• Medical condition to be studied:
  Epilepsy

  Bipolar disorder

  Migraine

  Pregnancy

Population studied

• Short description of the study population:
  Prescribers of valproate in settings of 5 European countries (France, Germany, Spain, Sweden, UK).
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  1067

Study design details

• Main study objective:
  The objective of the survey is to measure the effectiveness of the DHPC and educational material (EM), implemented as part of risk minimisation measures, by ascertaining the proportion of targeted physicians who understood and implemented the latest prescribing conditions and safety information about valproate provided in the DHPC and EM.
• Data analysis plan:
  The statistical analysis will be conducted using the SAS® softwareV9.4on Windows™ (SAS Institute, North Carolina, USA).The statistical results of the five countries will be presented in the same report, overall, per country and per physician’s specialty group.All the analysis will be descriptive in nature and no statistical comparison will be done in this study.Continuous variables will be described by their number (of valid cases, of missing values), mean, standard deviation, and median, Q1, Q3, minimum and maximum.Categorical variables will be described as the total number and relative percentage per category. These will be the percentage per category.Free text answers to open-ended questions will be categorised by theme, listed according to the frequency.Confidence intervals of 95% will be evaluated, when relevant.The proportions of correct and appropriate answers to selected questions asked in the questionnaire will be expressed among physicians.

Documents

Study results

valproate-PASS survey report abstract v1 2018-01-16