clinical implications of pharmacoepidemiology …¸rensen.pdf · pharmacoepidemiology is the study...

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HENRIK TOFT SØRENSENAARHUSUNIVERSITYAU

CLINICAL IMPLICATIONS OF

PHARMACOEPIDEMIOLOGY

RESEARCH

”PAST EXPERIENCE”

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Pharmacoepidemiology is the study of the use of and the effect of

drugs in large numbers of people. The term ‘pharmaco-

epidemiology’ obviously contains two components, pharmaco- and

epidemiology.

- Brian Strom

DEFINITION OF PHARMACOEPIDEMIOLOGY

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Probably the most well-known example of pharmacoepidemiology is based on 16 cases

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Ændr 2. linje i overskriften DEFINITION OF CLINICAL IMPLICATION

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1. Which tests/examinations should be used to diagnose a

disease and predict its course, while reducing false positive and

false negative results so far as practical (diagnosis)?

IN MY VIEW, THE FOUR BASIC CLINICAL QUESTIONS ARE:

Modern Epidemiology

Vandenbroucke and Sørensen

In press

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2. What is the expected course of a disease, e.g., spontaneous

cure or progression without clinical intervention (natural history)

or with treatment (clinical course) (prognosis).

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3. To what extent will a specific clinical intervention be beneficial

in terms of curing or preventing a disease, slowing its

progression, or reducing its symptom burden (intervention)?

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4. What are the risks — side effects, unintended adverse effects or

complications — of selected treatments and interventions, and

the safety and quality of clinical care (risk - harm)?

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Much pharmacoepidemiology

gets lost in translation into clinical medicine.

LOST IN TRANSLATION

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The young physician starts life with 20 drugs for each disease, and

the old physician ends life with one drug for 20 diseases.

-William Osler

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1. Different views on study design and data collection methods and the

movement of evidence-based medicine

2. Too much focus on statistical significance

3. Ongoing problems with data quality and disease classification

SOME REASONS FOR ”LOST IN TRANSLATION”

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1. DIFFERENT VIEWS ON STUDY DESIGN AND DATA COLLECTION METHODS AND THE MOVEMENT OF EVIDENCE-BASED MEDICINE

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Ændr 2. linje i overskriften 1991

Kenneth Rothman

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Travels to Boston University and the Framingham Heart Study

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Ændr 2. linje i overskriften HERSHEL JICKBoston Collaborative Drug Surveillance Program

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Ændr 2. linje i overskriften SLONE EPIDEMIOLOGY CENTER

1 7

Allen A. Mitchell

Dennis Slone

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They used a health insurance

database in Seattle and did

Nested case-control studies

BOSTON COLLABORATIVE DRUG SURVEILLANCE PROGRAM

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AROUND 1990, BOSTON COLLABORATIVE DRUG SURVEILLANCE PROGRAM MOVED TO THE GENERAL PRACTICE DATABASE IN THE UK

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They did ongoing prospective

hospital-based case-control

studies based on interviews.

Much better counfounder control

but problems with recall bias

A total of 521 patients under age 45 with

breast cancer were compared with 521

controls matched for age, time of interview,

and geographic area. Oral contraceptive

use before the first birth was reported by

155 patients and 137 controls

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DEVALUATION OF COHORT AND CONTROLSTUDIES, 1992

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Ændr 2. linje i overskriften HIERACHY OF STUDY DESIGN

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There is controversy about observational studies when the

focus is on the intended benefit due to lack of blinding and

poor control for unmeasured confounding.

We reviewed the reasons for possible discrepancies

between RCTs and observational studies.

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COMPARISON OF POOLED ODDS RATIO FROM OBSERVATIONAL STUDIES AGAINST POOLED ODDS RATIO FROM RANDOMISED CONTROLLED TRIALS ON THE SAME QUESTION

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2. TOO MUCH FOCUS ON STATISTICAL SIGNIFICANCE

Significance testing has led to far more

misunderstanding and misinterpretation

than clarity in interpreting study results

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Ændr 2. linje i overskriften APROTININ AND SAFETY

Hiatt WR, N Engl J Med 2006; 355:2171-2173

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Hiatt WR, N Engl J Med 2006; 355:2171-2173

Karkouti et al. appear to be so different

from the findings of Mangano et al?

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Ændr 2. linje i overskriften WHY RESULTS ARE FALSE

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is a consequence of the convenient, yet ill-founded strategy of

claiming conclusive research findings solely on the basis of a

single study assessed by formal statistical significance, typically

for a p-value less than 0.05. Research is not most appropriately

represented and summarized by p-values, but, unfortunately,

there is a widespread notion that medical research articles

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3. ONGOING PROBLEMS WITH DATA QUALITY AND DISEASE CLASSIFICATION

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The key issue of registry studies is to what extent the data collected

are reliable. Not for those issues that are registered, but mostly for

those that are not (false negatives). Thus, my main concerns affect

data reliability and their classification.

COMMENT, SEPTEMBER 2019

Reviewer, Journal of

Hepatology, 2019

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Ændr 2. linje i overskriften EXAMPLE OF DATA QUALITY

Recorded in the electronic medical records in Denmark Central Region

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Many types of problems limit the usefulness of the ICD-10

diagnoses in clinical care.

All codes are abstracts of the clinical care.

PROBLEMS WITH TRANSLATING ICD-10 CODES AND RELEVANT ENDPOINTS INTO CLINICAL PRACTICE

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➢ Variation in coding between persons doing the coding

➢ Errors in coding

➢ Errors and variations in the clinical diagnosis on which the coding

is based

➢ Limitations in the specificity of available codes

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➢ Laterality in paired organs such as legs is not recorded

➢ Limited classification of disease severity

➢ Some endpoints – such as recurrences and soft endpoints – are

not recorded

➢ Very few data on diagnostic criteria and the outcome of tests

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1. Research training

a) Scientists

b) Editors

c) Readers

2. Better data quality

3. Better classification systems

THE FUTURE

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clinical implications of pharmacoepidemiology …¸rensen.pdf · pharmacoepidemiology is the study...

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