An Introduction to Critical

Appraisal
Laura Wilkes
Trust Librarian
West Suffolk Foundation Trust
Laura.Wilkes@wsh.nhs.uk

Last updated May 2012

Learning Outcomes
By the end of this session you will:
o
o
o
o

Understand what Critical Appraisal is

Be aware of some of the different types of research
Be able to interpret basic statistics within a research paper
Gain experience in critically appraising a research paper

Evidence Based Practice

"Evidence-based medicine is
the conscientious, explicit
and judicious use of current
best evidence in making
decisions about the care of
individual patients.
Sackett, 1996

Hierarchy of Evidence

Types of Research
Systematic Reviews
A literature review focused on a single question which tries to
identify, appraise, select and synthesize all high quality research
relevant to that question.
Combines results of several RCTs or other types of evidence
Systematic reviews follow a clear sequence of steps:
Defining an appropriate question
Searching the literature published and unpublished, English & nonEnglish
Assessing the studies involves 2 independent reviewers
Combining the results & producing a bottom-line
Placing the findings into context

Advantages
Limits bias
Good quality evidence
Added power by synthesising individual study results

Types of Research
Experimental:
Randomised Controlled Trials (RCTs)
Randomly assign individuals to an intervention group or a
control group in order to measure the effectiveness of an
intervention.
Gold standard for treatment evaluations
However, some studies are not suitable for RCTs

Types of Research
Observational Studies
Cohort Studies
A non-experimental study design
Follows a group of people (a cohort), and then looks at how
events differ among people within the group.
Follow up period can be years or decades
Prospective cohort studies (which track participants
forward in time) are more reliable than retrospective
cohort studies
Can be expensive to conduct

Types of Research
Observational

Case-Control Study
Examines a group of people who have experienced an
event (usually an adverse event) and a group of people who
have not experienced the same event, and looks at what
risk factors both groups have been exposed to
Retrospective, therefore prone to recall bias, but quick &
involve small numbers
Primary method of studying new or unusual outcomes

Case-Series
Analysis of series of people with the disease
there is no comparison group

Critical Appraisal
The process of systematically weighing up the quality
and relevance of research to see how useful it is in
decision making
It is the balanced assessment of benefits and strengths
of research against its flaws and weaknesses
Increases the effectiveness of your reading
It can help you make informed decisions

Is a skill that needs to be practised

How do I Appraise?
You dont need to be a statistics expert

Ready-made checklists help you focus on the most

important aspects of the article
Different checklists available for different types of
research (RCTs, systematic reviews, case-control
studies, etc).
Checklist for Qualitative research
Available free from CASP

http://www.casp-uk.net

Critical Appraisal
Critical appraisal of any study design must assess:
Validity
Were sound scientific methods used?
Chance / Bias / Confounding Factors

Results
What are the results and how are they expressed?

Relevance
Are the findings generalisable can they be applied to
settings / situations outside the research study? Do these
results apply to my local context?

Potential Errors of Research

Chance
A random error appearing to cause an association between an
intervention and an outcome. Probability of a random error is
estimated using statistics (p values & confidence intervals)

Bias
The deviation of results from the truth due to systematic
error in the research methodology
Selection bias when two groups being studied differ
systematically in some way
Observer bias where there are systematic differences in the
way groups are treated or in how information is collected

Confounding Factors
An error of interpretation
Where part of the observed relationship between two variables
is due to the action of a third variable
Known confounders: e.g. age, gender, smoking, etc.

Critical Appraisal of an RCT

Screening questions:
1. Did the study ask a clearly focused research question?
Patient / Intervention / Outcome
Is it relevant to you?

2. Did the authors use an appropriate research method?

Is an RCT the most appropriate?

If the answer to these questions is YES you can carry

on with the rest of the checklist!

RCT Appraisal Checklist continued

Detailed Questions:
3. Were participants appropriately allocated to groups?
Sample:
Is it representative of the target population (the population to which the
results will be applied)
Convenience sampling?
Exclusion / Inclusion criteria do you agree?
If too selective results may not be generalisable
Bias?

Are the groups balanced?

Important that groups are similar at the beginning of a trial so there is more
chance of differences at the end being due to the intervention
Look at the Baseline Characteristics Table

Was group allocation truly random?

Bias can occur if patients, carers, or researchers can influence allocation

Randomisation
Randomisation ensures individuals have an equal chance of being
allocated to any Group
Potential confounding factors will be equally distributed
between groups
Successful randomisation requires that group allocation cannot be
predicted in advance allocation concealment avoids bias
Allocation concealment ensures all those involved in the trial are
unable to predict the allocation of the next participant until that
participant is enrolled. Methods include telephone randomisation,
or using consecutive sealed opaque envelopes.
A good study should indicate who generated the randomisation
sequence, the method used, and how concealment was achieved
& monitored

Randomisation Methods: Computer

Generated Sequence
E.g.:
4,8,3,2,7,2,6,6,3,4,2,1,6,2,0,.
Two Groups (criterion: even-odd):
AABABAAABAABAAA
Three Groups:
(criterion:{1,2,3}~A, {4,5,6}~B, {7,8,9}~C; ignore 0s)

BCAACABBABAABA

Permuted Block Randomisation

Used for small studies to maintain reasonably good
balance among groups
With a block size of 4 for two groups (A,B), there are 6
possible permutations and they can be coded as:

1=AABB, 2=ABAB, 3=ABBA, 4=BAAB, 5=BABA, 6=BBAA

Each number in the random number sequence in turn
selects the next block, determining the next four
participant allocations (ignoring numbers 0,7,8 and 9).
e.g., The sequence 67126814. will produce BBAA AABB
ABAB BBAA AABB BAAB.

Stratified Block Randomisation

A set of permuted blocks is generated for each
combination of prognostic factors
E.g. age group, severity of condition, and treatment
centre.

Stratification means having separate block

randomisation schemes for each combination of
characteristics (stratum)
For example, in a study where you expect treatment
effect to differ with age and sex you may have four
strata: male over 65, male under 65, female over 65
and female under 65

Questions continued
4. Were participants, staff and study personnel blind to
participants study group?
Withholding information about the assigned interventions from people
involved in the trial who may be influenced by this knowledge
Eliminates error through bias
Is blinding always possible?
Different levels of Blinding
Single- blind Trial
Either the researcher or the subject is blind to the allocation
Double-blind Trial
Both researcher and subject are blinded
Triple-blind Trial
Subject, researcher and analyst

 5. Were all the participants who entered the trial accounted

for at its conclusion?
Loss to follow up?
A common cause of missing data, especially in long-term studies
How important are the losses?
5% probably OK but >20% poses threat to validity
Losses equally distributed?

Intention to treat analysis?

Analysing people at the end of the trial, in the groups to which they
were randomised, even if they did not receive the intended
intervention
Maintains randomisation
Prevents bias caused by loss of participants

6. Were all the participants in all groups followed up and data

collected the same way?
Were groups treated equally?
Followed over the same time period / received same attention
Bias?
Differences in the way data collected, measurements taken etc.
if individuals know which group they have been allocated to

 7. Did the study have enough participants to

minimise the play of chance?
Before calculating the sample size, a clinically
significant treatment effect is estimated

POWER Calculation: calculates how large the sample

should be in order to have a high chance of detecting a
true difference between the groups.
Avoids a type I (false positive) or type II (false negative)
error
Calculated before the study begins

Look for 80% - 90% power probability of finding a

significant difference with a given sample size
Sample size increases when a small treatment effect is
expected & with higher power.

Are the Results Significant?

8. How are the results presented and what is the
main result?
What sort of data have they got & have they used
appropriate statistical tests?
Are the results expressed in terms of likely harm or
benefit?
Relative Risk
Numbers Needed to Treat

How meaningful is the result?

Event Rates

Number of people experiencing an event as a proportion of the

number of people in the population

Form the basis of other calculations

Control Event Rate (CER)

Experimental Event Rate (EER)

Emerg Med J 2008 25: 26-29:

Proportion with recurrent headache (whole sample)

CER = 12/31 = 39%

EER = 8/30 = 27%

Risk of benefit and harm

Relative Risk (RR) = compares the risk in 2 different groups
of people
tells us how many times more likely it is that an event will
occur in the treatment group relative to the control group
EER / CER
Relative Risk of 1 means the risk is the same in each group

<1 = treatment reduces risk of event

>1 = treatment increases risk of event

27/39 = 0.69 = treatment reduces risk of event

Risk of headache is 0.69 times lower in the treatment group
than in the control group.

Risk continued
Absolute risk reduction (ARR)
Difference in risk between experimental and
control groups
Risk of Event in Control Group Risk of Event
in intervention group
ARR=0 Treatment has no effect
ARR positive Treatment is beneficial
ARR negative Treatment is harmful
39% - 27% = 12%
Dexamethasone reduces the absolute risk of
recurrent headache by 12%

Relative Risk Reduction (RRR)

tells us the reduction in the rate of the outcome in the
treatment group relative to that in the control group

ARR / CER Or

1 RR

0.12 / 0.39 = 0.31 = 31%

1-0.69 = 0.31 = 31%

Dexamethasone reduces the risk of recurrent headache

by 31% relative to that occurring in the control group.

Absolute Risk Reduction & Relative

Risk Reduction

Results of hypothetical trial of a new drug for

myocardial infarction

Compare with Low Risk Patients

Later studied in a lower risk population:
10% mortality rate at 30 days among
untreated
7.5% mortality among treated
Absolute Risk Reduction is therefore 2.5%
10% - 7.5% = 2.5%
Relative Risk Reduction is 25%
2.5 / 10 = 0.25 = 25%
Relative Risk Reduction is often more
impressive than Absolute Risk Reduction
The lower the event rate the smaller the
absolute risk reduction

Odds Ratio

Treatment

If odds is greater than 1

then the event
(outcome) is more likely Placebo
to happen than not.

No
headache

Odds Ratio = odds in

treatment group / odds
in control group

Headache

Odds = number of
events / number of non
events

Odds

8/31

23

0.35

12/3
2

12

20

0.6

Odds Ratio = 35/60 = 0.59

Odds of recurrent headache almost 50% less in the
treatment group

Numbers Needed to Treat

Measures the impact of a treatment or intervention
States how many patients need to be treated in order to
prevent an event which would otherwise occur.
NNT = 10 means that 10 patients need to be treated to
prevent one adverse outcome
The closer to 1 the better
Calculation:
1 / ARR (if ARR expressed as a proportion)
100/ARR (if ARR expressed as a %)
100/12 = 8

Results
9. How precise are the results?

P Values
P=Probability
A p-value is a measure of statistical significance which tells
us the probability of an event occurring due to chance
alone
P values only from 0 to 1

If P Value is very small (e.g. P<0.001) the result is unlikely

to be due to chance (1 in 1000)
Generally, look for P<0.05 (1 in 20)

P - values
In simple terms, probability (p-value) can only take values
between 0 and 1:
0|-----------------------|--------------------|1
Impossible....... Absolutely certain
If p=0.001 the likelihood of a result happening by chance is extremely
low: 1 in 1000
If p=0.05 it is fairly unlikely that the result happened by chance 1 in 20

If p=0.5 it is fairly likely that the result happened by chance 1 in 2

If p=0.75 it is very likely that the result happened by chance 3 in 4

Confidence Intervals
An alternative way of assessing the effects of
chance
The result of the trial is a point estimate if
you ran the trial again you will get a different
result
The Confidence Interval gives the range in which
you think the real answer
The 95% CI is the range in which we are 95%
certain that the true population value lies
Look at how wide the interval is, and the values
at each end
E.g. RR = 0.69 95% CI 0.33 to 1.45

Forest Plot Simple Example

Line of No Effect
Individual sample
size

Combined
Results

Best Estimate

If the CI crosses the line

of no effect, then the
results of that study are
not statistically significant

Confidence Interval

Favours Treatment

The shorter the

Confidence Interval (CI)
the more confident we
can be that the results
are true

Favours Control

Line of No Effect =
1 for Relative Risk or
Odds Ratio
0 for Mean results

Relevance
10. Were all important outcomes considered so the
results can be applied?
Does your local setting / population differ from that in the
research in ways that would produce different results?
Can you provide the same treatment in your local setting?
Does any benefit reported outweigh any harm?
Should policy or practice change as a result of this
research?

Is there a Systematic Review on the subject?

Check the Cochrane Library
No Cochrane Reviews, but 2 Other Reviews Systematic
Reviews but not produced by the Cochrane Collaboration.

Conclusion
Critical Appraisal is part of Evidence Based Healthcare

It takes practice
Use CASP checklists
Depth of Appraisal is your choice
Only you can assess usefulness

Useful websites
www.healthknowledge.org.uk/interactivelearning/finding-and-appraising-the-evidence
www.thennt.com/
www.casp-uk.net/
www.wikipedia.org very good for a basic guide to
statistics in critical appraisal. Search for critical
appraisal.