1. Study identification
EU PAS Register NumberEUPAS9181
Official titleReacciones adversas a medicamentos que motivan ingreso hospitalario en pacientes de edad avanzada
Study title acronym
Study typeObservational study
Brief description of the study
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Department/Research groupClinical Pharmacology Service
Organisation/affiliationBellvitge University Hospital/IDIBELL
Details of (Primary) lead investigator
Title Dr
Last name Pedrós
First name Consuelo
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
National study
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/04/201501/04/2015
Start date of data collection08/04/201508/04/2015
Start date of data analysis04/05/201504/05/2015
Date of interim report, if expected
Date of final study report01/07/201501/07/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherNo specific funding100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Pedrós
First name Consuelo
Address line 1Servicio de Farmacología Clínica
Address line 2Hospital Universitario de Bellvitge
Address line 3c/Feixa Llarga s/n
CityL’Hospitalet de Llobregat
Postcode08907
CountrySpain
Phone number (incl. country code)34-932607220
Alternative phone number34-932607279
Fax number (incl. country code)34-932607223
Public Enquiries
Title Dr
Last name Pedrós
First name Consuelo
Address line 1Servicio de Farmacología Clínica
Address line 2Hospital Universitario de Bellvitge
Address line 3c/Feixa Llarga s/n
CityL’Hospitalet de Llobregat
Postcode08907
CountrySpain
Phone number (incl. country code)34-932607220
Alternative phone number34-932607279
Fax number (incl. country code)34-932607223
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Adverse drug reaction
8. Population under study
Age
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects1500
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
The Pharmacovigilance Programme of Bellvitge University Hospital collects cases of ADRs identified by a systematic daily review of admission diagnoses. Patients admitted with diagnoses included in a pre-defined list of diseases or syndromes potentially caused by drugs are identified. Their medical records are reviewed by a clinical pharmacologist in order to assess causality.
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Primary scope : Disease epidemiology
12. Main objective(s)
What is the main objective of the study?
The aim of this study is to assess the prevalence of ADR-related hospital admission in an elderly population.
Are there primary outcomes?Yes
The primary endpoint is urgent admission caused by an ADR in an elderly population.
Are there secondary outcomes?Yes
Hospitalization data, demographics data, drug exposure data, ADRs data, drug-reaction associations, number of emergency hospital admissions, number of in-hospital deaths
13. Study design
What is the design of the study?
Cross-sectional study
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
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.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted