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

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

AAPSGlobal Clinical research and

Pharmacovigilance Presentation

Clinical Research and Pharmacovigilance Program

Introduction

• Adverse events (AEs) – unintended injuries or complications caused by healthcare management systems including:

1. Death2. Disability3. Prolonged hospital stay

Aim

• To estimate the incidence of AEs among patients in Canadian acute care hospitals

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)

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

(Baker et al. 2004)

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

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.

Screening Process

(Baker et al. 2004)

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 biasHindsight 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.

(Baker et al. 2004)

ReferencesBaker 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.

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