CRITICAL APPRAISAL

UNTUK ARTIKEL TERAPI

Scenario 1
A mother brught her doughter, a 12 month baby girl. To primary health centre
where you serve for duty. This young mother told the doctor that her doughter has
suffered from abrupt onset of 3 or more loose stolls per day witg sign for sone
dehydration. The doctor treated the patient with oral rehydration solution and
observe her carefully. You have read the guideline for treating infants with
diarrhea that is recommended to give Zinc supplementation. You would like to
recommend this treatment to the doctor, but you wonder how effective the zinc
supplement to cure the diarrhea and reducing duration of diarrhea episode.

Instructions
1. Please a clinical question fo those scenario, formulating PICO and formulate
keywors!
2. Please search the article (it should be Randomized Controlled Trial) from
pubmed. Explain how many article do you find for each key word and
combination between keywords. If you have decided an article to answer the
clinical question, please axplain why this article is choosen?
3. Please explain what is the objective of the study, how the methods and what
are the result of the study. Do critical appraisal using the worsheet therapy !
4. Based on the critical appraisal, the article you have choosen is the goog article
or not? Based on the article you have choosen, what is your answer fot the
clinical question?
1. Pertanyaan klinis dari skenario 1, PICO dan kata kunci
Clinical question: Apakah pemberian suplemen zinc pada anak diare dapat
menurunkan durasi episode diare?
P : children with diarrhea
I : zinc supplement
C : No zinc supplement
O : reducing duration of diarrhea episode
Keywords: child* AND zinc supplement AND reducing diarrhea
2. Proses pencarian artikel
Database Date of Search strategy Number of articles
searched search found
PubMed 8 April 2013 Keyword: child* AND zinc 41 articles
Clinical supplement
Queries
Category: Therapy
Scope: Narrow

Filters activated:
Randomized Controlled Trial
Free full text available
Published in the last 5 years

Keyword: child* AND reducing 27 articles

diarrhea

Category: Therapy
Scope: Narrow

Filters activated:
Randomized Controlled Trial
Free full text available
Published in the last 5 years

Keyword: child* AND zinc 3 articles

supplement AND reducing
diarrhea

Category: Therapy
Scope: Narrow

Filters activated:
Randomized Controlled Trial
Free full text available
Published in the last 5 years
 Dari 3 artikel yang ditemukan 1 artikel tentang efektifitas terapi suplemen
Zinc pada anak anemia dan 1 artikel tentang efek modifikasi antara suplemen
zinc dengan cobalamin terhadap lamanya diare anak usai 6-30 bulan maka
artikel yang dipilih adalah Effect of Preventive Supplementation with Zinc
and Other Micronutrients on Non-Malarial Morbidity in Tanzanian Pre-
School Children: A Randomized Trial

3. Critical appraisal
Judul: Effect of Preventive Supplementation with Zinc and Other
Micronutrients on Non-Malarial Morbidity in Tanzanian Pre-School Children:
A Randomized Trial
Tujuan
Tujuan penelitian adalah menilai efektifitas suplemen zinc dan multipel
mikronutrien pada diare dan penyebab morbiditas diare non malaria pada
anak.
Metodologi
Penelitian dilakukanan pada 612 anak-anak di pedesaan Tasmania yang
berusia 6-60 bulan, dilakukan tehnik random pada anak untuk kelompok anak
yang mendapatkan suplemen zinc (10 mg) saja, multinutrien tanpa zinc, multi
nutrien dengan zinc, atau plasebo. Anak-anak diikuti selama rata-rata 45
minggu. Selama tindak lanjut, dicatat episode morbiditas.
Hasil
Tidak ditemukan bukti bahwa suplemen zinc yang diberikan bersamaan
dengan multinutrien mempengaruhi besarnya efek zinc terhadap angka diare,
penyakit pernapasan, demam, atau penyakit lainnya (sakit dengan gejala yang
meliputi kulit, telinga, mata dan abses, tetapi tidak termasuk trauma atau luka
bakar). Suplemen zinc mengurangi tingkat bahaya diare sebesar 24% (4%
-40%). Sebaliknya, multinutrien tampaknya meningkatkan angka ini (HR:95%
CI: 1,19; 0,94-1,50), terutama pada anak dengan infeksi Giardia asimtomatik
pada awal (2,03; 1,24-3,32). Zinc juga dilindungi episode demam tanpa
lokalisasi tanda-tanda (0,75; 0,57-0,96), tetapi tidak ditemukan bukti bahwa
hal itu mengurangi jumlah keseluruhan kunjungan klinik.
Patients : children with diarrhea
Intervention : zinc supplement
Comparison : multi-nutriens without zinc, multi-nutriens with zinc, placebo
Outcome(s) : reducing diarrhea
1a. R- Was the assignment of patients to treatments randomised?
What is best? Where do I find the information?
Centralised computer randomisation is The Methods should tell you how patients
ideal and often used in multi-centred trials. were allocated to groups and whether or not
Smaller trials may use an independent randomisation was concealed.
person (e.g, the hospital pharmacy) to
“police” the randomization.

This paper: Yes  No  Unclear 

Comment: Children were randomized within 6 strata defined by malaria
infection (binary) and age class (6–17 months, 18–35 months and 36–60 months) and
randomly permuted blocks with size randomly selected of 4 or 8. Children received daily
supplements with either zinc alone (10 mg as gluconate), multi-nutrients without zinc,
zinc combined with multi-nutrients or placebo.

1b. R- Were the groups similar at the start of the trial?

What is best? Where do I find the information?
If the randomisation process worked (that The Results should have a table of
is, achieved comparable groups) the groups "Baseline Characteristics" comparing the
should be similar. The more similar the randomized groups on a number of
groups the better it is. variables that could affect the outcome (ie.
There should be some indication of age, risk factors etc). If not, there may be a
whether differences between groups are description of group similarity in the first
statistically significant (ie. p values). paragraphs of the Results section.

This paper: Yes  No  Unclear 

Comment: Baseline characteristics were similar between intervention groups (Table 2)
2a. A – Aside from the allocated treatment, were groups treated equally?
What is best? Where do I find the information?
Apart from the intervention the patients in Look in the Methods section for the follow-
the different groups should be treated the up schedule, and permitted additional
same, eg., additional treatments or tests. treatments, etc and in Results for actual use.

This paper: Yes  No  Unclear 

Comment:
Children received daily supplements with either zinc alone (10 mg as gluconate), multi-
nutrients without zinc, zinc combined with multi-nutrients or placebo. Supplements were
packed as transparent blisterstrips, each containing 15 capsules with powder that was
similar in taste and appearance for all 4 intervention groups. Supplementation and follow-
up continued until 12 March 2009, when the trial was stopped for all children
simultaneously.
 2b. A – Were all patients who entered the trial accounted for? – and were they
analysed in the groups to which they were randomised?
What is best? Where do I find the information?
Losses to follow-up should be minimal – The Results section should say how many
preferably less than 20%. However, if few patients were randomised (eg., Baseline
patients have the outcome of interest, then Characteristics table) and how many
even small losses to follow-up can bias the patients were actually included in the
results. Patients should also be analysed in analysis. You will need to read the results
the groups to which they were randomised section to clarify the number and reason for
– ‘intention-to-treat analysis’. losses to follow-up.
This paper: Yes  No  Unclear 
Comment: loses to follow up
5
Children recieve suplement zinc =3,2 %
153
3
Multinutrients without zinc =1,9 %
155
3
Multi nutrients winth zinc =1,9 %
151
4
Placebo =2,6 %
153

 lost to follow up no more than 20%

3. M - Were measures objective or were
which treatment was being received?
What is best?
It is ideal if the study is ‘double-blinded’ –
that is, both patients and investigators are
unaware of treatment allocation. If the
outcome is objective (eg., death) then
blinding is less critical. If the outcome is
subjective (eg., symptoms or function) then
blinding of the outcome assessor is critical.
the patients and clinicians kept “blind” to
Where do I find the information?
First, look in the Methods section to see if
there is some mention of masking of
treatments, eg., placebos with the same
appearance or sham therapy. Second, the
Methods section should describe how the
outcome was assessed and whether the
assessor/s were aware of the patients'
treatment.

This paper: Yes  No  Unclear 

Comment:
Supplements were packed as transparent blister strips, each containing 15 capsules with
powder that was similar in taste and appearance for all 4 intervention groups. Capsules
were color-coded to reduce the chance that children would receive the wrong supplement.
The color code was not disclosed to the researchers until after the database had been
finalized  double blind (participants and researcher)
What were the results?
1. How large was the treatment effect?
What is the measure? What does it mean?
Relative Risk (RR) = risk of the The relative risk tells us how many times more
outcome in the treatment group / risk likely it is that an event will occur in the
of the outcome in the control group. treatment group relative to the control group. An
RR of 1 means that there is no difference
between the two groups thus, the treatment had
no effect. An RR < 1 means that the treatment
decreases the risk of the outcome. An RR > 1
means that the treatment increased the risk of the
outcome.

RR = EER/CER
81
( 153 ) x 100 %
99
( 153 ) x 100 % RR < 1, zinc suplement decrease the risk of
diarrhea
0.53/0.65 = 0.82

Absolute Risk Reduction (ARR) =
risk of the outcome in the control
group - risk of the outcome in the
treatment group. This is also known as
the absolute risk difference.
ARR = (CER-EER)
= 0.65-0.53
= 0.12 (12%)
The absolute risk reduction tells us the absolute
difference in the rates of events between the two
groups and gives an indication of the baseline
risk and treatment effect. An ARR of 0 means
that there is no difference between the two
groups thus, the treatment had no effect.
The absolute benefit of tretment is 12% reducing
in the dearrhea

Relative Risk Reduction (RRR) =
absolute risk reduction / risk of the
outcome in the control group. An
alternative way to calculate the RRR is
to subtract the RR from 1 (eg. RRR =
1 - RR)
The relative risk reduction is the complement of
the RR and is probably the most commonly
reported measure of treatment effects. It tells us
the reduction in the rate of the outcome in the
treatment group relative to that in the control
group.

RRR = (CER-EER)/CER The treatment reduced the risk of diarrhea by

= 0.12/0.65 18% relative to that occurring in the control
= 0,18 group
 Number Needed to Treat (NNT) = The number needed to treat represents the
inverse of the ARR and is calculated number of patients we need to treat with the
as 1 / ARR. experimental therapy in order to prevent 1 bad
outcome and incorporates the duration of
treatment. Clinical significance can be
determined to some extent by looking at the
NNTs, but also by weighing the NNTs against
any harms or adverse effects (NNHs) of therapy.

NNT = 1/ARR We would need to treat 8 children to reduce 1

diarrhea
= 1/12%
=8
2. How precise was the estimate of the treatment effect?
The true risk of the outcome in the population is not known and the best we can do is
estimate the true risk based on the sample of patients in the trial. This estimate is called
the point estimate. We can gauge how close this estimate is to the true value by looking
at the confidence intervals (CI) for each estimate. If the confidence interval is fairly
narrow then we can be confident that our point estimate is a precise reflection of the
population value. The confidence interval also provides us with information about the
statistical significance of the result. If the value corresponding to no effect falls outside
the 95% confidence interval then the result is statistically significant at the 0.05 level. If
the confidence interval includes the value corresponding to no effect then the results are
not statistically significant.

Will the results help me in caring for my patient?

(ExternalValidity/Applicability)
The questions that you should ask before you decide to apply the results of the study
to your patient are:
 Is my patient so different to those in the study that the results cannot apply? No,
they aren’t
 Is the treatment feasible in my setting? Yes, it is
 Will the potential benefits of treatment outweigh the potential harms of treatment
for my patient? Yes, it will

4. Berdasarkan critical appraisal, maka artikel peneltian ini adalah artikel yang
baik. Suplement zinc efektif menurunkan durasi episode diare dibandingkan
dengan tidak mendapatkan suplement zinc. Pada kasus anak yang mengalami
diare suplemet zinc dapat diberikan sebagai pengobatan untuk menurunkan
durasi dan episode dari diare.