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Pharmacovigilance Presentation Workshop - Carolina H.H. B.Sc, Dr. Mehran Marashian, Dr. Mahshid Bagheri, Gopi Patel B.Sc., Ana Franco B.Sc., Porfessor Peivand Pirouzi
1. The Incidence of Adverse Events
(AEs) among hospital patients in
Canada in 2000
Baker et al. 2004
Presented by:
Carolina H.H. B.Sc, Dr. Mehran Marashian,
Dr. Mahshid Bagheri, Gopi Patel B.Sc., Ana Franco B.Sc.
Research Program Director: Professor Peivand Pirouzi
AAPS
Global Clinical research and
Pharmacovigilance
Presentation
Clinical Research and Pharmacovigilance
Program
2. Introduction
• Adverse events (AEs) – unintended injuries or
complications caused by healthcare management
systems including:
1. Death
2. Disability
3. Prolonged hospital stay
3. Aim
• To estimate the incidence of AEs among patients
in Canadian acute care hospitals
4. Methods
• Design: Retrospective Chart Review (RCR)
RCR,known also as a medical record review, is a type of
research design in which pre-recorded, patient-
centered data are used to answer one or more research
questions.
• Randomly selected community hospitals in 5 Canadian
provinces (QB, AB, BC, NS, ON)
• In each province:
1. Teaching hospital (1)
2. Large community hospitals (1)
3. Small community hospitals (2)
5. Chart Review Process
• Computerized data collection form
• Training to physicians and nurses
• Standard set of hospital charts and training manuals
• Two stage-review process:
• Stage 1: Reviewed by nurses
• Identify criterion for potential AE occurrence
• Stage 2: Reviewed by physicians
• Whether there is an AE
• Whether AE was caused by health care management
• Whether AE could be prevented
7. Results and Conclusions
• Physicians identified AEs in 255 charts out of
3750 charts screened by the Stage 1 nurses (7%)
• AE rate = 7.5 /100 admissions
• 1/3 is judged to be preventable
8. Advantages of Using RCR for
Measuring Harm
• Uses readily available data from patient charts.
• Quality data produced if:
- proper, frequent training and monitoring is provided to
personnel for data collection (study manual)
- use explicit key variables
- blinding of personnel collecting the data
- use inclusion/exclusion criteria for screening patient
charts.
10. Disadvantages of Using RCR
• Judgment of AE may be biased
• Expensive
• Records incomplete if training is inadequate or criterion for
assessment is not accurate.
• Cannot determine causality
• Hindsight bias
Hindsight bias, also known as the knew-it-all-along effect or
creeping determinism, is the inclination, after an event has
occurred, to see the event as having been predictable, despite
there having been little or no objective basis for predicting it.
12. References
Baker GR, Norton PG, Flintoft V, et al. The Canadian Adverse Event
Study: the incidence of adverse events among hospital patients in
Canada. CMAJ, 2004, 170:1678-1686.