1. Defining a Researchable
Question: the PICOS Approach
Cochrane Reviewers’ Training
Workshop
January 22-23, 2009
Session Presenter: Marcus Vaska
Slides adapted from “Defining a Researchable Question..” by
Miranda Cumpston, with additions and deletions by Dr. Roger
Thomas; “Review Protocol and Designing Your Research Question,”
by the Cochrane Collaboration
2. Session Goals
Learn about strategies/tips used to help
design a research question
Learn about the PICOS approach, and be
able to apply this method when defining your
own researchable question
3. Strategies/Tips for Designing a
Research Question
Main Objective: summarize the question in order to
help the reader understand the evidence and/or make
a practical decision about a health care decision
Remember:
Remain neutral, not biased (do not impose own values and/or
preferences when defining your research question)
Although you may be an expert in your particular subject area,
don’t assume your readership is. Therefore, the Cochrane
review needs to be easy to understand and follow by a person
who may have only marginal knowledge about the topic.
4. A Brief Note on
Cochrane Review Titles
All Cochrane titles and reviews of diagnostic
tests utilize one of the following standard
formats:
<intervention> for <health problem>
i.e. <antibiotics> for <tuberculosis>
<intervention A> vs. <intervention B. for <health
problem>
i.e. <modern medicine> vs. <traditional, homeopathic
remedies> for <malaria>
<intervention> for <health problem> in
<participant group/location>
i.e. <education programs> for <AIDS> in
<pastoralist/nomadic societies>
5. Sample Topic for
Demonstration Purposes
In lieu of traditional homeopathic remedies,
can the administration of modern
medicine help alleviate the malaria
epidemic among children in Africa?
6. The PICOS Approach:
What is it and Why is it Important?
PICOS = a framework designed to make the process
of defining and designing a research question easier
Why is it Important?
To create a clear question
To identify the information needed to answer that question
To translate the question into searchable terms
To develop and refine the search approach
“It looks easy. It can be tricky. It is absolutely
invaluable.”
[Evidence-Based Answers to Clinical Questions for Busy Clinicians. (2006). The
Centre for Clinical Effectiveness, Monash Institute of Health Services
Research, Melbourne, Australia, p. 2]
7. The PICOS Approach
P
Population, Patient
I
Intervention
C
Comparison
O
Outcome
S
Study Design
8. P = Population/Patient
When defining this question component,
consider the following patient
characteristics:
Disease/condition, including the duration,
localization, and type of symptoms
Age
Gender
Setting
Standard Diagnostic Criteria
9. Sample: Modern Medicine for
Treating Malaria
Who are the Children in Africa
P (Population,
patients? Who is (excluding
Patient)
affected? Any adults) suffering
exclusions? from malaria
Describe the
specific patient
population
characteristics
and/or context of
the disease
10. P (Population/Patient)
Considerations to Remember
Restrictions on populations/settings
should be based on a sound rationale –
important for Cochrane reviews to be
globally relevant
11. I = Intervention
When deciding on the intervention(s) that
will be present in a systematic review,
the following should be explicitly
described:
Type of intervention
Intensity of intervention
Frequency of intervention
Duration of intervention
12. Sample: Modern Medicine for
Treating Malaria
I (Intervention) What is being Modern medicine
done? What (antibiotics)
interventions
should be
evaluated?
Define the
intervention!
13. I (Intervention)
Considerations to Remember
Interventions can consist of: treatment,
diagnostic/screening test, exposure, or
prognostic factor
Should all variations be included?
How will co-interventions, or trials that
only include part of an intervention be
handled?
14. C = Comparison
Main alternative being considered
Intervention should be explicitly defined
Placebo
Standard therapy
No treatment
Another treatment
Usual care (“the gold standard”)
15. Sample: Modern Medicine for
Treating Malaria
What is the Traditional
C
alternative to the medicine
(Comparison)
intervention? How (homeopathic
effective are remedies)
different
interventions?
16. C (Comparison)
Considerations to Remember
Control groups
Inactive Control
Active Control
17. O = Outcome
When determining the desired/expected
outcomes of a systematic review, it is key to
consider the following:
Explicit outcome measures and tools
Standardized, validated, established outcome
measures appropriate for the disease condition
Focus on outcomes that are important to patients
Side effects (if known) should be included
Timing of outcome measures should be described
18. Sample: Modern Medicine for
Treating Malaria
What are the Malaria
O (Outcome)
relevant prevention, death
outcomes? What reduction
do you want to
accomplish,
measure,
improve? Define
specific outcomes
19. O (Outcome)
Considerations to Remember
Include all important outcomes (primary
and secondary)
Include adverse effects
Consider Economic Data
Do Not Include an outcome that is trivial
or meaningless to decision makers!
20. S = Study Design
The type of study design utilized is
dependent on the type of question
defined. The presence of bias with
different designs should be considered
before deciding which one is most suited
to the question being pondered
21. Types of Study Designs
(Interrupted) Time Series
A research design that collects observations at multiple time
points before and after an intervention (interruption). The
design attempts to detect whether the intervention has had an
effect significantly greater than the underlying trend.
Case-Control Study
A study that compares people with a specific disease or
outcome of interest (cases) to people from the same
population without that disease or outcome (controls), and
which seeks to find associations between the outcome and
prior exposure to particular risk factors. This design is
particularly useful where the outcome is rare and past
exposure can be reliably measured. Case-Control studies are
usually retrospective, but not always
Source: Glossary of Terms in the
Cochrane Collaboration Version 4.2.5
May 2005
22. Types of Study Designs
(continued)
Cohort Study
An observational study in which a defined group of people
(the cohort) is followed over time. The outcomes of people in
subsets of this cohort are compared, to examine people who
were exposed or not exposed (or exposed at different levels)
to a particular intervention or other factor of interest
Randomized Controlled Trial (RCT)
An experiment in which two or more interventions, possibly
including a control intervention or no intervention, are
compared by being randomly allocated to participants. In
most trials one intervention is assigned to each individual but
sometimes assignment is to defined groups of individuals (for
example, in a household) or interventions are assigned within
individuals (for example, in different orders or to different parts
of the body)
Source: Glossary of Terms in the
Cochrane Collaboration Version 4.2.5
May 2005
23. Sample: Modern Medicine for
Treating Malaria
What is the best Therapy =
S (Study
study design to prospective RCT;
Design)
answer the Prevention =
RCTCohort
question ?
StudyCase
Control
24. S (Study Design)
Considerations to Remember
Most reviews use RCT’s as a threshold
(RCTs are considered the least biased
form of evidence)
Cochrane and Campbell collaborations
may also take evidence from interrupted
time series
26. Exercise: Interventions to Increase
Influenza Vaccination Rates
Who are the
P (Population, Age=adults, elderly,
seniors, NOT
patients? Who is
Patient) children, NOT
affected? Any
adults <60)
exclusions?
Gender= male &
Describe the female
specific patient Setting=institution
population (hospital, care centre)
characteristics vs. community
(home, public place)
and/or context of
Disease/Condition =
the disease
influenza
27. Exercise: Interventions to Increase
Influenza Vaccination Rates
I (Intervention) What is being Patient
done? What interventions;
interventions Administrative
should be interventions;
evaluated? Health care
Define the workers (HCW)
intervention interventions;
Societal
interventions
28. Exercise: Interventions to Increase
Influenza Vaccination Rates
No alternative
What is the
C
intervention, other
alternative to the
(Comparison) than to observe the
intervention? How effectiveness of
effective are different interventions
different
interventions? Comparison of
influenza rates,
illness, mortality
29. Exercise: Interventions to Increase
Influenza Vaccination Rates
What are the Effects of
O (Outcome)
relevant interventions on
outcomes? What both immediate
do you want to and long-term
accomplish, changes in
measure, influenza
improve? Define vaccination rates,
specific outcomes and on outcomes
of interest
30. Exercise: Interventions to Increase
Influenza Vaccination Rates
What is the best RCTs
S (Study
study design to
Design)
answer the
question ?