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

Multinational, multi-channel survey
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

100000095363
acitretin
100000095629
isotretinoin
100000095664
alitretinoin
Population studied

Short description of the study population

A survey of healthcare professionals prescribed or administered oral retinoids (acitretin, alitretinoin and isotretinoin) to female patients of childbearing potential according to the local label in seven European countries.
Inclusion criteria:
HCPs
· HCPs who prescribed or administered oral retinoids (acitretin, alitretinoin and isotretinoin) to female patients of childbearing potential in the past 6 months
Patients
· Female gender
· Childbearing age (i.e., 13 to 49 years of age)
· Receiving prescriptions for oral retinoids (acitretin, isotretinoin or alitretinoin) at the time of the survey, or who have received prescriptions within the last 6 months
· Willing, understanding and consenting to participate in this self-administered survey. For patients between 13 to 17 years of age, the survey shall be filled out by their parent, guardian or caregiver.

Exclusion criteria
HCPs
· Inactive and retired HCPs (when documented information is available to identify them) will be deleted from the contact lists before randomization.
· HCPs who are not involved in patient treatment (e.g. researchers)
· HCPs who may have conflicts of interest with the survey (i.e., HCPs employed by regulatory bodies, pharmaceutical companies)
· HCPs who belong to a practice from which there are already at least two other HCPs participating in the survey
· HCPs who have participated in testing the questionnaire for comprehensibility, consistency and the appropriateness of medical terms
Patients
· Patients who may have conflicts of interest with the survey (i.e. patients employed by regulatory bodies, pharmaceutical companies)
· Patients who have a condition that prevents them from becoming pregnant and having children

Age groups

Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)

Special population of interest

Pregnant women

Estimated number of subjects

600
Study design details

Main study objective

Primary objective: to assess the effectiveness of the PPP based on pre-defined success thresholds for PPP awareness, knowledge, and adherence in HCPs and patients

Data analysis plan

Results will be presented, overall and at country level stratified by HCP speciality and per molecule. Continuous variables will be described by the number of valid cases and missing data, mean, standard deviation, median, first quantile (Q1), third quantile (Q3), minimum, and maximum. Categorical variables will be described as the total number and relative percentage per category. Confidence intervals (CIs) of 95% will be calculated when relevant. Individual awareness, knowledge and adherence scores will be calculated as the percentage of correctly answered survey questions. Overall domain level scores will be calculated as the mean of individual scores. Calculations will first be performed on raw data, which will be stratified by speciality for the HCP survey, and weighted according to the real proportion of targeted responders for both the HCP and patient surveys per country to accurately reflect the population the survey seeks to measure.
Documents
Study results

38096_20220215 Oral Retinoids_PASS_Survey_Final Report_v1.0_Abstract

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