Retrospektive Ärztebefragung zu Vorkommen und Ursachen von Stürzen bei älteren Patienten unter besonderer Betrachtung von Antihistaminika der ersten Generation als mögliche Sturzursache (Echo)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Retrospective survey, Post-authorisation safety study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (R06AA02) diphenhydramine

  diphenhydramine

  (R06AA09) doxylamine

  doxylamine
• Medical condition to be studied:
  Fall

Population studied

• Short description of the study population:
  Resident physicians who were general practitioners/internists with no specialisation or neurologists.
• 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:
  500

Study design details

• Main study objective:
  The primary objective of this study is to investigate a possible causal relationship between falls in patients at ≥ 65 years of age and the intake of antihistamines of the first generation with sedative effect.
• Outcomes:
  Incidence and causes of falls in older patients in connection with the intake of antihistamines of the first generation with sedative effect.
• Data analysis plan:
  Data evaluation by means of descriptive statistics.