Transcript Effectiveness risk

Benefit and harm:
Effectiveness and risk
• Key concepts in therapeutics
• Key issues in communication
I Ralph Edwards
Marie Lindquist
With acknowledgements to Andrew Herxheimer
'Benefit' and its opposite 'Harm'
There are individual and general definitions possible for benefit and harm
"To be an advantage to"
– Societal
"Something that
contributes to or
increases one’s
wellbeing"
– Individual
A BENEFIT TO SOCIETY MAY NOT BE A BENEFIT TO AN
INDIVIDUAL AND VICE VERSA
NEITHER IS HARM TO SOCIETY THE SAME AS HARM
TO AN INDIVIDUAL AND VICE VERSA
'Benefit' in societal terms
• Benefit
– Increased overall
population health
• 'Fitter' working
population
– Decreased
expenditure on health
• Increased efficiency
• Shift to less costly
options
• Harm
– Increased longevity
without health
– More costly health
care
• Costs shifted or hidden
• Diversion of funding
from more 'effective'
areas
'Benefit' in societal terms
• Benefit
– Measles vaccine
– Total abolition of
tobacco advertising
– Discontinuation of the
NSAIDS that cause
the most GI bleeding
• Effective only
– The prolongation of life
in diabetics
– Treatment of HIV
– The use of 'Viagra'
•Which shows that decisions on health are not only based on public health
BENEFIT but also EFFECTIVENESS
' Effectiveness' and 'risk'
• Effectiveness is an indication that a drug
works: this is not the same as benefit
The true balanced concepts
• Efficacy v. hazard
– Pre-clinical/clinical study
• Effectiveness v. risk
– Post-marketing clinical use studies
• Benefit v. harm
– What is actually experienced by a patient or
patients
Perception of effectiveness and
risk from medicines
Mild stroke
Hypertension 160/100
Insurance medical Hypertension 160/100
Difference?
Treatment
Same treatment
Not only pathology, but also in PERCEPTIONS of what chances one will
take
Communication challenges
• Different audiences: different perceptions
– Doctors, patients, media, lawyers
• How to express the effectiveness/ risk
balance
• How to compare between treatments
• How to handle changes in knowledge
– HRT - myocardial infarction
– Blood pressure therapy (ALLHAT)
Communication challenges
• Expression of message
– Retention of information: reference
• Complexity
– Impact
• Confidentiality v. openness
– Access
– Information flow (Learned intermediary)
• Seriousness of issue
– speed of communication
Effectiveness/risk
communication
•
•
•
•
The correct message
To the right audience
By the right medium
Consequences
– Message received?
– Message understood?
– Followed up?
– Acted upon appropriately?
Communication challenges
Message sent
!
New!
Follow up
Message received
Message understood
Message acted upon
Studies
More messages !
Action appropriate
Benefit and harm from
medicines
Edwards, IR., Wiholm, B-E., Martinez C. (1996) "Concepts in Risk-Benefit
Assessment" Drug Safety 15(1): 1-7
CIOMS 4
• Compare like-with-like
– Principle of 3's
• Disease; effect of drug; ADRs
• Seriousness; duration; frequency
• Three worst and three most frequent ADRs
– Then consider cost...