Critical Appraisal

EMB Harm

Clinical Question:
Does ice cream
consumption cause
headache?

EBM

Title:
Ice Cream Evoke Headaches (ICE-H)
Study: Randomised Trial of
Accelerated versus Cautios Ice
Cream Eating Regimen
Maya Kaczorowski, Janus Kaczorowski
British Medical Journal
2002

Objective of study:
To compare the effect of two ice cream regiments
on the incidence of ice cream headaches.
Methods:
Study design: prospective randomized trial.
There is an explanation about how to calculate
sample size.

71 participant in each group.

Participants were randomized.

Green dot questionnaire: 100 ml ice cream, to be eaten

within > 30 seconds about half ice cream, and continue at
their own pace.
Red dot questionnaire: 100 ml ice cream, to be eaten
within < 5 seconds.

The primary outcome: incidence and

duration of headache, assessed by
participants 5-10 minutes after eating ice
cream.

Analysis: intention to treat, two tailed.

EBM-HARM WORKSHEET
Validity ?
Importance ?
Applicability ?

Are the results of this harm

study valid?
1.

Were there clearly defined groups of patients,

similar in all important ways other than
exposure to the treatment or other cause?

Yes.

Eligible participants (students) were

approached and provided verbal consent.

Characteristics of the two groups are

similar: mean of age, life time prevalence of
ice cream headaches, regular headaches.

Randomization: concealed green and red

dot questionnaire

Are the results of this harm

study valid?
2.

Were treatments/exposures and clinical

outcomes measured in the same ways in both
groups (Was the assessment of outcomes
either objective or blinded to exposure)?

No,

Treatments: concealed
But the outcome measured by participants
their self tend to be subjective (lack of
blinding)

Are the results of this harm study

valid?
3.

Was the follow-up of study patients

sufficiently long (for the outcome to occur)
and complete?

Yes,
long 5-10 minutes after eating ice
cream.??
complete no loss to follow-up.

Are the results of this harm study

valid?

Do the results of the harm study fulfill some of

the diagnostic test for causation?

4.

Is it clear that the exposure preceded the onset of the outcome?

Is there a doseresponse gradient?
Is there any positive evidence from a dechallenge rechallenge
study?
Is the association consistent from study to study?
Does the association make biological sense?

Yes, ice cream can induce headache, not

only in hot weather but also in winter .

Are the valid results of this harm study

important?
1.

What is the magnitude of the association

between the exposure and outcome

RR = ?
NNH =?

Importance:
Headaches
(+)

Headaches
(-)

Accelerate
d eating
group

20

53

73

Cautious
eating
group
total

63

72

RELATIVE RISK
29
116
(RR) = A/(A+B) : C/(C+D)
= 20/73 : 9/72
= 0.274/0.125
= 2.2

total

145

NUMBER NEEDED TO HARM (NNH)

NNH = 1 / { A/(A+B)} {C/(C+D)}

NNH = 1/0.274-0.125
NNH= 1/0.149
NNH= 6.71
We need 7 patients to be exposed to
accelerated eating group to produce
one additional headache event.

Are the valid results of this harm study

important?
2.

What is the precision of the estimate of

the association between the exposure
and the outcome
By using CAT Maker: RR with Confidence
interval 95%: 2.19 (1.93-2.45)

Can this valid and important evidence

about harm be applied to our patient?
1.

Is our patient so different from those included

in the study that its results cannot apply?
No, our patients mostly similar to the patients in
the study

2.

What is our patients risk of benefit and harm

from the agent?
- to decrease the incidence of ice cream induced
headaches.
- do not finish eating ice cream within < 5
seconds.

Can this valid and important evidence

about harm be applied to our patient?
3.

What are our patients preferences,

concerns and expectations from this
treatment?
no more symptoms of headache as
consequences of eating ice cream.

4.

What alternative treatments are

available?
no alternative treatment needed.

THANK YOU