DK Critical Appraisal EBM Harm

8/19/2019 DK Critical Appraisal EBM Harm

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Critical AppraisalCritical Appraisal

EMB HarmEMB Harm


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Clinical Question:Clinical Question:

Does ice creamDoes ice cream

consumption causeconsumption cause

headache?headache?

EBMEBM


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Title:Title:

Ice Cream Evoke Headaches (ICE-H)Ice Cream Evoke Headaches (ICE-H)

Study: a!domised Trial o"Study: a!domised Trial o"

Accelerated versus Cautios Ice Accelerated versus Cautios Ice

Cream Eati!# e#ime!Cream Eati!# e#ime!

Maya $ac%oro&ski' a!us $ac%oro&skiMaya $ac%oro&ski' a!us $ac%oro&ski

British Medical our!alBritish Medical our!al

****


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Objective of study:Objective of study: To compare the eect of two ice cream regimentsTo compare the eect of two ice cream regiments

on the incidence of ice cream headaches.on the incidence of ice cream headaches.

Methods:Methods: Study design: prospective randomized trial.Study design: prospective randomized trial.

There is an eplanation about how to calculateThere is an eplanation about how to calculatesample size.sample size. !" participant in each group.!" participant in each group.

#articipants were randomized.#articipants were randomized.

$reen dot %uestionnaire: "&& ml ice cream' to be eaten$reen dot %uestionnaire: "&& ml ice cream' to be eatenwithin ( )& seconds about half ice cream' and continue atwithin ( )& seconds about half ice cream' and continue attheir own pace.their own pace.

*ed dot %uestionnaire: "&& ml ice cream' to be eaten*ed dot %uestionnaire: "&& ml ice cream' to be eatenwithin + , seconds.within + , seconds.


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The primary outcome: incidence andThe primary outcome: incidence and

duration of headache' assessed byduration of headache' assessed by

participants ,-"& minutes after eating iceparticipants ,-"& minutes after eating ice

cream.cream.

nalysis: intention to treat' two tailed. nalysis: intention to treat' two tailed.


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EBM-HAM +,$SHEETEBM-HAM +,$SHEET

alidity . alidity .Importa!ce .Importa!ce .

Applica/ility . Applica/ility .


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Are the results of this harmAre the results of this harm

study valid?study valid?1.1. Were there clearly defned groups o patientsWere there clearly defned groups o patients

similar in all important !ays other thansimilar in all important !ays other than

e"posure to the treatment or other cause?e"posure to the treatment or other cause?

Yes. Eligible participants (students) were

approached and provided verbal consent.

Characteristics of the two groups aresimilar: mean of age life time prevalence ofice cream headaches regular headaches.

!andomi"ation: concealed green and reddot #uestionnaire


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#.#. Were treatments$e"posures and clinicalWere treatments$e"posures and clinical

outcomes measured in the same !ays in %othoutcomes measured in the same !ays in %oth

groups &Was the assessment o outcomesgroups &Was the assessment o outcomes

either o%'ecti(e or %linded to e"posure)?either o%'ecti(e or %linded to e"posure)?

$o$o %reatments: concealed &ut the outcome measured by participants

their self tend to be sub'ective (lac ofblinding)

Are the results of this harmAre the results of this harm

study valid?study valid?


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*.*. Was the ollo!+up o study patientsWas the ollo!+up o study patientssu,ciently long &or the outcome to occur)su,ciently long &or the outcome to occur)and complete?and complete?

Are the results of this harm studyAre the results of this harm study

valid?valid?

-es -eslonglong +1/ minutes ater eating ice+1/ minutes ater eating icecream.??cream.??

completecomplete no loss to ollo!+up.no loss to ollo!+up.


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0.0. Do the results o the harm study ulfll some oDo the results o the harm study ulfll some o

the diagnostic test or causation?the diagnostic test or causation?

Are the results of this harm studyAre the results of this harm study

valid?valid?

s it clear that the e*posure preceded the onset of the outcome?s it clear that the e*posure preceded the onset of the outcome? s there a dose+response gradient?s there a dose+response gradient?

s there any positive evidence from a ,dechallenge rechallenge-s there any positive evidence from a ,dechallenge rechallenge-study?study?

s the association consistent from study to study?s the association consistent from study to study? oes the association mae biological sense?oes the association mae biological sense?

Yes ice cream can induce headache not Yes ice cream can induce headache notonly in hot weather but also in winter .only in hot weather but also in winter .


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1.1. What is the magnitude o the associationWhat is the magnitude o the association

%et!een the e"posure and outcome%et!een the e"posure and outcome

Are the valid results of this harm studyAre the valid results of this harm study

important?important?

2 ? 2 ?

334 2?334 2?


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Importance:Importance:

HeadachesHeadaches(0)(0)

HeadachesHeadaches(-)(-)

totaltotal

Accelerate Accelerate

d eati!#d eati!##roup#roup

** 1212 3232

/autious/autiouseatingeating

groupgroup

44 5252 33

totaltotal 44 665665 671671E8ATIE IS$ E8ATIE IS$

() 9 A(A0B) : C(C0;)() 9 A(A0B) : C(C0;)

9 *32 : 439 *32 : 43

9 *


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$$/ 0 1 2 3 A2(A4&)5 + 3C2(C4)5$$/ 0 1 2 3 A2(A4&)5 + 3C2(C4)5

$$/ 0 126.7896.17;$$/ 0 126.7896.17;$$/0 126.19?MBE >EE;E; T, HAM (>>H)


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#.#. What is the precision o the estimate oWhat is the precision o the estimate othe association %et!een the e"posurethe association %et!een the e"posureand the outcomeand the outcome

Are the valid results of this harm studyAre the valid results of this harm study

important?important?

By using C56 Ma7er: !ith ConfdenceBy using C56 Ma7er: !ith Confdenceinter(al 89: #.18 &1.8*+#.0)inter(al 89: #.18 &1.8*+#.0)


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1.1. s our patient so di;erent rom those includeds our patient so di;erent rom those included

in the study that its results cannot apply?in the study that its results cannot apply?

3o our patients mostly similar to the patients in3o our patients mostly similar to the patients in

the studythe study

#.#. What is our patient


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*.*. What are our patientuences o eating ice cream.

0.0. What alternati(e treatments areWhat alternati(e treatments are

a(aila%le?a(aila%le?

no alternati(e treatment needed.no alternati(e treatment needed.

Can this valid and important evidenceCan this valid and important evidence

about harm be applied to our patient?about harm be applied to our patient?


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T012 3O4T012 3O4

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DK Critical Appraisal EBM Harm