Effectiveness and Safety of SMART BoNT-A therapy with Dysport® in patients with post-stroke chronic upper limb spasticity in real-life setting (SMART-NIS)

ENCePP Code of conduct

No

Data sources

• Data sources (types):
  Other
• Data sources (types), other:
  - Patient medical file: The investigator or authorized medical staff will record clinical and treatment data (if applicable) from patients’ medical files into the electronic Case Report Form (eCRF). ; - Investigator scales: All data regarding the scales (DAS, MAS, Assessment of Pain (VAS)) used by the investigator during the study should be recorded from paper form into the eCRF or directly into the eCRF. ; - QoL questionnaire: SQoL-6D data will be collected on a paper questionnaire completed by the participant at visit 1, 2, 3 and 4 and captured in eCRF by investigator. ; - Questionnaire on patient-perceived satisfaction/ intention to continue / discontinue treatment and reasons for discontinuation, if applicable: data will be collected on a paper questionnaire completed by the participant at visit 3 and 4 and captured in eCRF by investigator.

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

• Check conformance:
  Unknown
• Check completeness:
  Unknown
• Check stability:
  Unknown
• Check logical consistency:
  Unknown

Data characterisation

• Data characterisation conducted:
  No