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)?

Yes,
 Treatments: concealed , outcomes measeured blind.
 outcome measured by participants their self  blind
 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?
4. Do the results of the harm study fulfill some of
the diagnostic test for causation?

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

 Is there a dose–response 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 (-) total

Accelerated 20 53 73
eating group
Cautious 9 63 72
eating group
total 29 116 145

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