Study type

Study type

Non-interventional study

Scope of the study

Other

If ‘other’, further details on the scope of the study

Assess the awareness, knowledge, and the self-reported compliance of physicians routinely prescribing fenfluramine with the recommendations provided the educational material on echocardiogram follow-up
Non-interventional study

Non-interventional study design

Cross-sectional
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(N03AX26) fenfluramine
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)

Estimated number of subjects

100
Study design details

Main study objective

Assess the awareness and knowledge of physicians routinely prescribing fenfluramine regarding the educational material on echocardiogram follow-up Assess the self-reported compliance of physicians routinely prescribing fenfluramine with the recommendations provided in the educational material on echocardiogram follow-up

Outcomes

Variables associated with 1) the awareness and knowledge of physicians routinely prescribing fenfluramine regarding the educational material on echocardiogram follow-up and 2) the self-reported compliance of physicians routinely prescribing fenfluramine with the recommendations provided in the educational material on echocardiogram follow-up will be collected. Variables associated with 1) the physician-reported distribution of educational material to patients/carers by physicians routinely prescribing fenfluramine and 2) the awareness, knowledge and self-reported compliance of physicians routinely prescribing fenfluramine regarding the physician-specific educational material on prevention of off-label use for weight management will be collected.

Data analysis plan

All assessment data will be summarised using descriptive techniques. Results will be presented overall and at the country level. The proportion of responding and non-responding physicians will be provided for each question in the questionnaire. The response option ‘I don’t know’ or ‘I don’t recall’ will be considered a neutral response and will still be included in the denominator for the analysis. Continuous variables will be described with summary statistics such as the total number of observations in the sample (i.e. n), mean, standard deviation, median, first quartile, third quartile, minimum, and maximum. Categorical variables will be described as the total number and relative percentage per category. Percentages will be calculated using the specified denominator in the table. Confidence intervals of 95% will be calculated when relevant.