Notes on Methodology Checklist 1: Systematic Reviews and Meta-analyses

Title

CRITICAL APPRAISAL JOURNAL

LOPERAMIDE THERAPY FOR ACUTE DIARRHEA IN CHILDREN
SYSTEMATIC REVIEW AND META ANALYSIS

Statement 1.1

The study addresses a clearly defined research question

Why is this important?

When does this

statement apply?

Before work starts on a systematic review, the Always applies.

research question to be answered should be
clearly stated along with the criteria to be used
to decide which studies will be included in or
excluded from the review.

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Response:
Yes. Where the research question is clearly stated. Reference to a
protocol, ethics approval, or pre-determined/a priori published
research objectives may meet this criterion.
1 Department of Pediatrics, University of California Davis,
Sacramento, California, United States of America, 2 Department of
Preventive Care, Group Health Cooperative,Seattle, Washington,
United States of America, 3 Center for Health Studies, Group Health
Cooperative, Seattle, Washington, United States of America, 4
Department of Health Services, University of Washington, Seattle,
Washington, United States of America, 5 Department of Pediatrics,
University of Washington, Seattle, Washington, UnitedStates of
America, 6 Department of Epidemiology, University of Washington,
Seattle, Washington, United States of America

21/08/2014
Review date: None

Statement 1.2

At least two people should select studies and extract data

What does this statement mean?

When does this

statement apply?
While extracting data from studies may be an Always applies.
objective process, there is always scope for
error or misinterpretation. Having two or more
people carry out data extraction independently
of each other reduces the risk of error or bias
creeping in. There should also be a clear
mechanism for arriving at consensus where
views differ.
Statement 1.3

Yes. Where the study clearly states that two or more people were
involved in data extraction, and that they were working independently
of each other. A method of reaching consensus is also described.
Data diekstraksi secara independen oleh dua penulis (STL dan DCG)
dan semua perbedaan pendapat dipecahkan dengan menggunakan
consensus.

A comprehensive literature search is carried out

What does this statement mean?

When does this

statement apply?

A systematic review must, by definition, Almost always.

include a comprehensive literature search
covering all likely sources of studies.
Definition of comprehensive is difficult as a
numer of factors influence the scope of a
search. As a minimum at least two major
electronic databases should be searched. Major
databases include the Cochrane library,
Embase, and Medline. Some subjects should
involve more specialized databases such as
AMED, CINAHL, or Psychinfo.
Statement 1.4

Response:

Response:
Yes. Where full details of the literature search are provided either in
the review itself or in a separate source that is available to those
evaluating the review (eg in an online supplement).
Sumber data yang dipelajari sudah tepat dan diperoleh melalui lebih
dari satu cara. Pengambilan data dilakukan secara acak dari database
terpercaya (Medline, EMBase, dan Cochrane Central Register of
Controlled Trials) dengan kata kunci diare, loperamide, dan Imodium.
Selain itu, data dasar kepustakaan berasal dari uji klinis terpercaya dan
tinjauan artikel yang memenuhi syarat, rincian uji klinis dari
organisasi kesehatan utama yang memfokuskan pada pencegahan
diare dan pengobatan, peneliti utama di lapangan, dan perusahaan
farmasi mayor yang memproduksi loperamide.

The authors clearly state if or how they limited their review by publication type
What does this statement mean?

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When does this

statement apply?
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Response:

21/08/2014
Review date: None

This comes back to inclusion / exclusion Always applies.

criteria. Authors will normally have a range of
clinical criteria to consider, but may decide to
impose additional limitations Common
limitations are study type, language of
publication, and published or unpublished
literature.

Statement 1.5

Yes. All criteria used to select studies are clearly specified.

Strategi pengambilan sampel dinyatakan dengan jelas. Pengambilan
sampel dilakukan secara acak dan dipilih melalui tiga uji penapisan
berdasarkan empat kriteria, yaitu desain penelitian tersebut (uji klinis
acak terkontrol), populasi penelitian (anak-anak diare akut yang
berusia kurang dari 12 tahun), intervensi (loperamide dibandingkan
control), dan ketersediaan data tentang hasil intervensi terhadap durasi
diare atau keparahan penyakit. Penelitian yang memenuhi keempat
criteria tersebut dimasukkan dalam tinjauan ini. Penelitian yang
meneliti kombinasi loperamide dan obat lain, misalnya antibiotika,
tidak dimasukkan dalam tinjauan ini. Namun, alasan strategi
pengambilan sampel tidak dijelaskan.

The included and excluded studies are listed

What does this statement mean?

When does this

statement apply?

A list of included and excluded studies should Always applies.

be provided.

Response:
Yes. Where those studies included in the review, or excluded
following application of the agreed exclusion criteria, are listed.
Listing bibliographic details only for excluded studies is acceptable.
Penelitian yang memenuhi keempat kriteria yaitu desain penelitian
tersebut (uji klinis acak terkontrol), populasi penelitian (anak-anak
diare akut yang berusia kurang dari 12 tahun), intervensi (loperamide
dibandingkan control), dan ketersediaan data tentang hasil intervensi
terhadap durasi diare atau keparahan penyakit.
Penelitian yang meneliti kombinasi loperamide dan obat lain,
misalnya antibiotika, tidak dimasukkan dalam kriteria inklusi.

Statement 1.6

The characteristics of the included studies are provided

What does this statement mean?

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When does this

statement apply?
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Score should be:

21/08/2014
Review date: None

In an aggregated form such as a table, data Always applies.

from the original studies should be provided
on the participants, interventions and
outcomes. The ranges of characteristics in all
the studies analyzed e.g., age, race, sex,
relevant socioeconomic data, disease status,
duration, severity, or other diseases should be
reported.

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Yes. Where data from the original studies is provided in sufficient

detail to allow assessment of the comparability of the study
populations. Note that a format other than a table is acceptable, as
long as the information noted here is provided.
Karakteristik subjek yang digunakan dalam penelitian adalah 1788
anak-anak dengan diare akut yang berusia kurang dari 12 tahun
dimana > 975 anak diberikan loperamide dan 813 anak diberikan
placebo. Kebanyakan anak hanya mengalami diare ringan.

21/08/2014
Review date: None

Statement 1.7

The methodological quality of the included studies is assessed and documented

What does this statement mean?

When does this

statement apply?

This is effectively asking whether the authors Always applies.

appraised the individual studies in a similar
way to how you are appraising the review.

Response:
Yes. Where the authors report the appraisal of individual studies, and
how this was done - eg through use of a tool such as the Jadad scale or
Cochrane risk of bias tool or sensitivity analysis etc, with a result for
EACH study (low or high is fine, as long as it is clear which
studies scored low and which scored high)
Didokumentasikan dalam QUOROM Checklist
Semua indicator dari methodological quality dijelaskan dalam table 3
dan table 4 pada jurnal.

Statement 1.8

The scientific quality of the included studies was assessed appropriately

What does this statement mean?

When does this

statement apply?

The methodological rigor and scientific Always applies

quality of the individual papers should be
considered in the analysis and the conclusions
of the review, and explicitly stated in
formulating recommendations.

Response:
Yes. Where the review includes information on individual study
quality along with outcome data and conclusions from each study. May
also say something like the results should be interpreted with caution
due to poor quality of included studies.. Note that this question cannot
score yes if the review scored no for item 7.
Hasil penelitian ini dapat menjawab pertanyaan penelitian , yakni
penggunaan loperamide berpengaruh terhadap durasi diare atau jumlah
tinja diare pada anak-anak dengan diare akut yang berusia kurang dari
12 tahun dan terdapat efek samping berat loperamide berupa letargi,
ileus, dan kematian.

Statement 1.9

Appropriate methods are used to combine the individual study findings

What does this statement mean?

File name : Notes on the use of Checklist 1 Systematic reviews

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When does this

statement apply?
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Response:

21/08/2014
Review date: None

For the pooled results, a test should be done to Always applies

ensure the studies were combinable, to assess
their homogeneity (eg -squared test). If
heterogeneity exists a random effects model
should be used and/or the clinical
appropriateness of combining should be taken
into consideration (ie is it sensible to
combine?). Indicate yes where the authors
mention or describe heterogeneity or
variability between results and discuss the
consequences (eg where authors declare they
cannot pool results because of heterogeneity).

Statement 1.10

No. Where heterogeneity is noted but not dealt with adequately in

discussing results.
None of the factors examined in the sub-analyses could account for
study heterogeneity in the studies of diarrhea duration or in the studies
of diarrhea frequency; the p-values of tests of homogeneity of these
subgroups remained ,0.01.
We were unable to test whether a consistent definition of diarrhea
resolution could account for study heterogeneity since no two of the
studies of diarrhea duration or diarrhea frequency defined diarrhea
resolution in the same way.
Third, we found evidence of heterogeneity for some outcomes. We
could not account for the observed heterogeneity in several subgroup
analyses. Despite this heterogeneity, both fixed-effects and randomeffects summaries were consistent with beneficial effects of
loperamide in the overall estimates; the heterogeneity suggests the size
of the benefit varies by some other factor that we were not able to
Identify.

The likelihood of publication bias is assessed

What does this statement mean?

When does this

statement apply?
It is always possible for publication bias to Always applies
exist, but it cannot be proved or disproved
absolutely. A good review should nevertheless
take account of the possibility that it may be
present. An assessment of publication bias
should include a combination of graphical aids
(eg funnel plot, other available tests) and/or
statistical tests (eg Egger regression test,
Hedges-Olken test).
Statement 1.11

Response:
No. Where assessment has not been carried out.

Conflicts of interest are declared.

File name : Notes on the use of Checklist 1 Systematic reviews

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21/08/2014
Review date: None

What does this statement mean?

When does this

statement apply?

Any financial or other relevant interests of the Always applies.

review authors should be reported, along with
any financial support provided for the conduct
of the review. Ideally, that authors should also
report on the funding of individual studies
included in the review.

Response:
No. Where there is no discussion of sources of support.

Section 2

This section is where you give your views on the review overall.

Item 2.1

Rate the overall methodological quality of the study, using the following as a guide:
+
Acceptable (+): Most criteria met. Some flaws in the study with an associated risk of bias.

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Produced by: Carolyn Sleith

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21/08/2014
Review date: None