Adverse drug reactions that lead to hospital admission in elderly patients

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medical condition to be studied:
  Adverse drug reaction

Population studied

• Short description of the study population:
  Elderly patients with adverse drug reactions (ADR)-related hospitalization.
• Age groups:
  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1500

Study design details

• Main study objective:
  The aim of this study is to assess the prevalence of ADR-related hospital admission in an elderly population.
• Outcomes:
  The primary endpoint is urgent admission caused by an ADR in an elderly population. Hospitalization data, demographics data, drug exposure data, ADRs data, drug-reaction associations, number of emergency hospital admissions, number of in-hospital deaths
• Data analysis plan:
  A descriptive analysis of all variables will be performed in the overall sample and also in age subgroups (65-74 years, 75-84 years and >=85 years). The results will be expressed using absolute and relative frequencies. The chi-square test will be used for multiple comparisons, the Bonferroni method will be applied if necessary.The prevalence of ADR-related admission will be calculated by dividing the number of patients admitted for ADRs and the total number of admissions through the emergency room during the study period. The 95% CI for this estimate will be calculated.

Documents

Study publications

Pedrós C, Formiga F, Corbella X, Arnau JM. Adverse drug reactions leading to ur…