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Study designs
21 Feb 2018 WJ Steinberg
Quantitative Research
Specific measurable
questions/characteristics
Generates numbers
Large representative samples
Quantifies known
Qualitative Research
1) Descriptive (describes)
2) Analytic (explains)
a) case-control
b) cohort
c) cross sectional
3) Experimental Studies (evaluates
intervention)
a) randomized controlled (clinical) trial
b) community trial
Choose the correct
study design for the job
Descriptive study design
Study Population
Study Sample
Measurement
Descriptive study design
Audit - common
Incidence vs Prevalence
Incident cases:
Number of new cases during a specific
period (for example 1 year)
Prevalent cases:
Number of cases of a given disease at
a given time
Exercise 1
1) Descriptive (describes)
2) Analytic (explains)
a) case-control
b) cohort
c) cross sectional
3) Experimental Studies (evaluates
intervention)
a) randomized controlled (clinical) trial
b) community trial
Analytic study design:
More correct?
Is smoking associated with lung
cancer?
Types of analytic study
designs
Case-control (retrospective –
starts at endpoint dx- works back
to exposure)
Cohort (prospective – starts with
exposure – observes for outcome)
Cross-sectional ( exposure and
outcome at one point in time)
Case - control Study
Study Sample
All registrars that specialised at UAH in the last 30 yrs
Controls:
Ideally from the same source population
as cases, so that if they had been
cases they would have been included
as cases
Case - control Study :
Study Sample
All registrars at UAH
Loss to follow-up
1) Descriptive (describes)
2) Analytic (explains)
a) case-control
b) cohort
c) cross sectional
3) Experimental Studies (evaluates
intervention)
a) randomized controlled (clinical) trial
b) community trial
Experimental study
Before-after study:
One group
Measurements made before and
after an intervention
Rx: C
Rx: A Rx: B
Placebo
Compares medication/treatments to
placebo
Randomization
Rx: C
Rx: A Rx: B
Placebo
Contamination:
Participants in one group receive the
intervention of the other group
Co-intervention:
Participants receive some other
treatment in addition to the
intervention treatment
Experimental study
Parallel design:
different groups of participants receive the
different interventions
Cross-over trial:
each participant receives all the interventions,
in a random order
Washout period in between intervention, only
of use if participant’s condition after washout
returns to level before intervention (chronic
conditions)
Experimental study
Ethics:
Written informed consent
Participant can withdraw
Adverse events noted and reported to
for example ethics committee
Under certain conditions participant
must be withdrawn, trial must stop
Intervention study:
Issues to be considered
Block randomisation
To ensure that at various stages of the
trial similar numbers are enrolled in
each group
Stratified randomisation
To ensure that the groups are identical
regarding some prescribed variables
Randomisation
Phase I trial
Determining levels of drug in blood, absorption,
excretion, safety
Usually done on healthy volunteers
Phase II trial
First investigation in patients
Usually a small group, often no comparison
group
Phase III trial
Large randomised controlled clinical trials for
proof of efficacy and further investigation of
safety
Strengths of study designs
Systematic review
Meta-analyse
Systematic reviews
“A systematic review is a
literature review focused on a
single question that tries to
identify, appraise, select and
synthesize all high quality
research evidence relevant to
that question” (Wikipedia)
Meta-Analysis
Types of questions:
Frequency of a certain condition
Diagnostic accuracy
Risk factors/causation
Prediction
Intervention/treatment
Reviews
Intervention or indicator
Outcome
(PICO)
PICO
P Patient / Problem
I Intervention
C Control
O Outcome
Example
Methodology – sampling /
selection of
participants
measurement
confounding
Reviews
Cochrane Collaboration –
reviews of effects of health care
interventions
www.cochrane.org
Campbell Collaboration –
reviews of educational, social
and legal interventions
www.campbellcollaboration.org
Systematic Review
criteria RCT’s
Summary of RCT’s
study---------outcome
study---------outcome
study---------outcome
Meta-analysis
criteria RCT’s
Statistical pooling
Overall effect
Levels of evidence AHCPR
Ia Evidence from meta-analysis of randomised
controlled trials
CLINICAL STATE
CIRCUMSTANCES
CLINICAL EXPERTISE
PATIENTS’ RESEARCH
PREFERENCES EVIDENCE
AND ACTIONS
Basic study designs
(chapter 7 new book)
1) Descriptive (describes)
2) Analytic (explains)
a) case-control
b) cohort
c) cross sectional
3) Experimental Studies (evaluates
intervention)
a) randomized controlled (clinical) trial
b) community trial
Task for Session 1