Evaluation of the Effectiveness of Risk Minimisation Measures: A Survey among Health Care Professionals to Assess their Knowledge and Attitudes on Prescribing Conditions of Instanyl® in France and the Netherlands

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:
  Cross-sectional

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

Study drug and medical condition

• Name of medicine:
  INSTANYL
• Medical condition to be studied:
  Cancer pain

Population studied

• Short description of the study population:
  Physicians prescribers, or potential prescribers, of Instanyl® who are targeted for the educational materials.
• 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:
  267

Study design details

• Main study objective:
  The objective of the survey is to measure the proportion of targeted physicians who received, understood and followed the safety information about Instanyl® provided in the updated educational materials.
• Data analysis plan:
  Continuous variables will be described by the number of valid cases and missing data, mean, standard deviation, median, Q1, Q3, minimum, and maximum. No missing data will be replaced. Categorical variables will be described as the total number and relative percentage per category. Confidence intervals of 95% will be calculated when relevant.Calculations will first be performed on raw data per specialty, and weighted according to the real proportion of targeted physicians in each country to accurately reflect the population the survey seeks to measure. Possible selection bias will be assessed by comparing the distributions of available characteristics (e.g. region, age, gender, type of practice and specialty) between respondent and non-respondent physicians.

Documents

Study results

Instanyl-5001 Study Report 24 Apr 2016