Chapter 1
description
Transcript of Chapter 1
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Chapter 1
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Chapter 2
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Dr Spock 1956 editionswitches his recommendation
to face down USA
1950 1960 1970 1980 1990 2000 2010
Second study Suggests harm
First studySuggests harm
UK
Systematic Review Published
Three further studies; two suggest harm
Dr Spock 1946 first editionrecommends face up
Back to Sleep”Campaigns
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1980 1985 1990 1995 2000 2005 2010
UK Medicines Control Agencywithdraws licence for eczema
First trialpublished in The Lancet
Positive review published but excludes largenegative trial
Review of 10 published and 10 unpublished
trials suppressed by theUK Department of Health
Evening primrose oilfirst suggested aspossible treatment
English Health Technology Assessment programme publishes review of trials: no beneficial effects
UK sales continue over the counter as “dietary supplement”
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Chapter 3
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1880 1900 1920 1940 1960 1980 2000 2020
Fisher and othersstart large trials of
less invasive surgery
Radical mastectomyextended in various
ways
Crile questions“more is better”in Life magazine
Rose Kushner publishes book on
breast cancerexperiences
Halsted develops radical mastectomy
Fisher trial and othersreveal no survival advantage
20 year follow-ups confirm findings
Some clinicians, in professional circles, question
need for radical surgery
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Chapter 4
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Early
detection
No screening Death
Ineffective screening DeathScreening
Lead Time
Usual
diagnosis
Effective screening DeathScreening
Lead Time
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A B Cno symptoms no symptoms symptoms no spread spread spread
Growth and spread of cancer in heavy smokers
Screening (early detection) Diagnosis (late detection)
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Chapter 5
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Patient with broken
ankle
Lower leg plaster?
No plaster?
New knowledge for better patient care in the future
Treat within a randomized trial
On-going clinical uncertainty with risk of harm
Dec
isio
n Ti
me
A
B
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Chapter 6
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Concealing treatment allocation by telephone randomization
The patient’s condition fits the trial, and she
has consented. Which treatment pack should I
give her?
Yes doctor, your patient is eligible. She will be
allocated to treatment pack X32. After the trial we will tell you what treatment X32 was.
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AAB B B
A
Randomize days within a person
Randomize individuals within a groupRandomize communities within a region
A B
A BB A
B A
Randomize eyes within a person
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Randomize
Surgery Medical
SurgeryDead
Final outcome
6/6 alive 6/8 alive
Die beforesurgery
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Chapter 7
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Death due to bleeding
Other continents
Continent A
Continent B
Continent C
COMBINED
Risk Ratio (95% Confidence Interval)
Treatment WorseTreatment Better0.6 0.7 0.8 0.9 1 1.10.5
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Chapter 8
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Chapter 12
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What will happen to 100 people like you in the next 10 years?
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1. What would happen if I do nothing?
2. What treatments can you suggest?3.Which might be best for me?4. What are the likely benefits? Are
there any downsides for me?
So the tests confirm our diagnosis. We need
to decide the best course of action for
you.
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Final Chapter
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Nearly a third of trial interventions not sufficiently described
Over half of planned study outcomes not reported
Most new research not interpreted in the context of systematic assessment of other relevant evidence
Unbiased and usable report?
Research Waste
Waste at four stages of research
Low priority questions addressed
Important outcomes not assessed
Clinicians and patients not involved in setting research agendas
Questions relevant
to clinicians and patients?
Over half of studies designed without reference to systematic reviews of existing evidence
Over half of studies fail to take adequate steps to reduce biases, e.g. unconcealed treatment allocation
Appropriate design and methods?
Over half of studies never published in full
Biased under-reporting of studies with disappointing results
Accessible full publication?
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