Evaluation of the Effectiveness of Risk Minimisation Measures: A Joint PASS Survey among Health Care Professionals to Assess their Knowledge and Attitudes on Prescribing Conditions of Thiocolchicoside containing Medicinal Products for Systemic Use in France, Greece, Italy and Portugal

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study

Non-interventional study

• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection
• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

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

Population studied

• Short description of the study population:
  General practitioners and specialists (rheumatologists and orthopedists / orthopedic surgeons) who prescribed systemic thiocolchicoside within the last 12 months.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  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:
  600

Study design details

• Main study objective:
  Whether the dear healthcare professionals communication (DHPC) and educational materials (EM), implemented as risk minimisation measures (RMM), were effective to ensure:- correct knowledge of physicians about prescribing conditions and safe use when prescribing systemic thiocolchicoside- appropriate
• Outcomes:
  to measure the effectiveness of the DHPC and EM, implemented as part of RMM, by ascertaining the proportion of targeted physicians who understood and implemented the latest prescribing conditions and safety information about systemic thiocolchicoside provided in the DHPC and EM. Specific objectives were to evaluate the proportion of physicians who:• prescribe systemic colchicoside only as adjuvant treatment of painful muscle contractures associated with acute spinal pathology in adults and in adolescents from 16 years onwards.• do not prescribe systemic thiocolchicoside for long-term treatment of chronic conditions.• follow the recommendations regarding doses
• Data analysis plan:
  The statistical analysis will be conducted using the SAS® softwareV9.3 on Windows™ (SAS Institute, North Carolina, USA).Results will be presented, overall and at country level per specialty. 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

Results tables

TCC report abstract