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WORKSHEET CRITICAL APPRAISAL

CHECKLIST FOR case control study


Adapted from:
CASP This work is licensed under the Creative Commons Attribution - NonCommercial-ShareAlike 3.0 Unported License. To view a copy of this
license, visit http://creativecommons.org/licenses/by-nc-sa/3.0/ www.casp-uk.net

How to use this appraisal tool


Three broad issues need to be considered when appraising a case control study:
Are the results of the trial valid? (Section A)
What are the results?

(Section B)

Will the results help locally?

(Section C)

The 11 questions on the following pages are designed to help you think about these issues systematically. The
first two questions are screening questions and can be answered quickly. If the answer to both is yes, it is
worth proceeding with the remaining questions. There is some degree of overlap between the questions, you
are asked to record a yes, no or can tell to most of the questions. A number of italicised prompts are given
after each question. These are designed to remind you why the question is important. Record your reasons for
your answers in the spaces provided. These checklists were designed to be used as educational tools as part of
a workshop setting. There will not be time in the small groups to answer them all in detail!
Cara menggunakan alat penilaian ini
Tiga isu yang luas perlu dipertimbangkan ketika menilai sebuah studi kasus kontrol:
Apakah hasil dari sidang valid? (Bagian A)
Apa hasilnya? (Bagian B)
Akankah hasil membantu secara lokal? (Bagian C)
11 pertanyaan pada alat ini dirancang untuk membantu Anda berpikir tentang masalah secara sistematis. Dua
pertanyaan pertama yang screening pertanyaan dan dapat dijawab dengan cepat. Jika jawaban untuk kedua
adalah "Ya", perlu dilanjutkan dengan pertanyaan yang tersisa.Ada beberapa derajat tumpang tindih antara
pertanyaan, Anda akan diminta untuk menjawab "ya", "tidak" atau "dapat memberitahu "untuk sebagian besar
pertanyaan. Sejumlah petunjuk dimiringkan diberikan setelah setiap pertanyaan. Alat Ini dirancang untuk
mengingatkan Anda mengapa pertanyaannya adalah penting. Merekam alasan Anda untuk jawaban Anda di
tempat yang tersedia.Daftar-pembanding ini dirancang untuk digunakan sebagai alat pendidikan sebagai
bagian dari pengaturan lokakarya. Tidak akan ada waktu di kelompok-kelompok kecil untuk menjawab mereka
semua secara rinci!

Critical Appraisal Skills Programme (CASP) Case Control Study Checklist 31.05.13

Title / Judul

Hygiene practices and sexual activity associated with urinary tract infection in pregnant women

Author / Peneliti :
F.N. Amiri, M.H. Rooshan, M.H. Ahmady and M.J. Soliamani

Publication by / Publikasi oleh :


Eastern Mediterranean Health Journal, Vol. 15, No. 1, 2009

DOES THIS STUDY


ADDRESS A CLEAR
QUESTION? (PICO
Question)
1. Were the following
clearly stated:
Patients/ Pasien
Intervention/ Intervensi/
Eksposure
Comparison Intervention/
Pembanding Intervensi
Outcome(s) / Keluaran
atau hasil

Yes

No

Cant
Tell

Pregnant women
Sexual activity

No sexual activity

Urinary tract infection

No

Cant
Tell

VALIDITY
(A) Are the results of the
study valid?
(A) Apakah hasil penelitian
yang valid?

Yes

Screening Questions
1. Did the study address
a clearly focused issue?
HINT: A question can be
focused in terms of
The population
studied
The risk factors
studied
Whether the study
tried to detect a
beneficial or harmful
effect?
Pertanyaan skrining

Yes on page 1, title and firstline abstract


Hygiene practices and sexual activity associated with urinary

tract infection in pregnant women

1. Apakah penelitian
membahas masalah yang
jelas terfokus?
PETUNJUK: Sebuah
pertanyaan dapat
difokuskan dalam hal
Populasi yang diteliti
Faktor risiko yang diteliti
Apakah penelitian
mencoba untuk
mendeteksi
menguntungkan
atau efek berbahaya?
2. Did the authors use an
appropriate method to
answer their question?
HINT: Consider
Is a case control study
an appropriate way of
Answering the question
under the circumstances?
(Is the outcome rare or
harmful)
Did it address the study
question?

Yes on page 2, 1st line paragraph under Methods:


This casecontrol study was performed on 100 women with
positive urine culture (cases) and 150 healthy pregnant women
(controls), matched for age, gestational age, parity, occupation and
socioeconomic and education status.

2. Apakah penulis
menggunakan metode yang
tepat untuk menjawab
pertanyaan mereka?
PETUNJUK: Pertimbangkan
Apakah studi kasus kontrol
dengan cara yang tepat
Menjawab pertanyaan dalam
situasi?
(Apakah hasilnya jarang atau
berbahaya)
Apakah itu menjawab
pertanyaan penelitian

Is it worth continuing?
Detailed questions
3. Were the cases
recruited in an
acceptable way?
HINT: We are looking for
selection bias which

Yes on page 2, first and second paragraph under Methods:


This casecontrol study was performed on 100 women with
positive urine culture (cases) and 150 healthy regnant women
(controls), matched for age, gestational age, parity, occupation and
socioeconomic and education status. The women were selected

might
compromise
validity of the findings
Are the cases defined
precisely?

Were the cases


representative
of
a
defined
population?
(geographically and/or
temporally?)

Was there an
established
reliable
system for selecting all
the cases
Are they incident or
prevalent?
Is there something
special about the cases?
Is the time frame of the
study
relevant
to
disease/exposure?
Was there a sufficient
number
of
cases
selected?
Was there a power
calculation?

3. Apakah kasus direkrut


dengan cara yang dapat
diterima?
PETUNJUK: Kami mencari
bias seleksi yang mungkin
membahayakan validitas
temuan

Apakah
kasus
didefinisikan secara tegas?
Apakah kasus wakil dari
populasi tertentu? (secara
geografis dan / atau
temporal?)
Apakah ada sistem yang
handal yang dibuat untuk
memilih semua kasus?
Apakah mereka insidens
atau prevalens?
Apakah ada sesuatu
yang khusus tentang

consecutively from those attending 5 public clinics at Babol


University of Medical Sciences for prenatal care from 1 January
2002 to 20 February 2004. The exclusion criteria were a history of >
2 episodes of UTI per year, urinary stones or urinary tract anomaly,
chronic disease (diabetes mellitus, sickle-cell anaemia),
consumption of any antibiotic or immune system inhibitory drugs in
the previous 3 months, or the presence of any abnormal vaginal
discharge.

kasus?
Apakah kerangka waktu
studi yang relevan dengan
penyakit / eksposur?
Apakah ada cukup
banyak kasus dipilih?
Apakah ada perhitungan
power penelitian?

4. Were the controls


selected in an acceptable
way?
HINT: We are looking for
selection bias which
might compromise The
generalisibilty of the
findings

Were the controls


representative of defined
population
(geographically and/or
temporally)
Was there something
special
about
the
controls?
Was the non-response
high?
Could
nonrespondents be different
in any way?
Are they matched,
population based or
randomly selected?
Was there a sufficient
number of controls
selected?
4. Apakah kontrol dipilih
dalam cara yang dapat
diterima?
PETUNJUK: Kami mencari
bias seleksi yang mungkin
kompromi
Temuan Umum
Apakah kontrol mewakili
dari populasi tertentu

Yes on page 3, third paragraph under Methods:


The women were instructed how to give a clean-catch midstream
urine specimen. The samples were sent to Babol Razi laboratory
and the fresh urine was tested immediately. Urinalyses and urine
cultures were used for the detection of UTI. A UTI was defined as
the presence of significant bacteriuria > 100 000 colony-forming
units per mL of urine.

(secara geografis dan /


atau temporal)
Apakah ada sesuatu
yang khusus tentang
kontrol?
Apakah non-respon
tinggi?
Bisa
nonresponden
berbeda
dengan cara apapun?
Apakah mereka cocok,
populasi berdasarkan atau
dipilih secara acak?
Apakah ada jumlah yang
memadai kontrol dipilih?

5. Was the exposure


accurately measured to
minimise bias?
HINT: We are looking for
measurement, recall or
lassification bias
Was the exposure
clearly defined and
accurately measured?
Did the authors use
subjective or objective
measurements?
Do the measures truly
reflect what they are
supposed to measure?
(Have they been
validated?)
Were the measurement
methods similar in the
cases and controls?
Did the study
incorporate blinding
where feasible?
Is the temporal relation
correct? (Does the
exposure of interest
precede the outcome?)
5. Apakah paparan diukur
secara akurat untuk

Yes on page 2-3, second paragraph under Methods:


Data on the womens genital hygiene and sexual practices were
collected by questionnaire completed by the midwives in the clinics.
The questionnaire asked about demographic variables, frequency of
coitus (per week in the previous 30 days), genital hygiene practices,
e.g. whether they usually urinated after coitus (> 15 minutes/< 15
minutes after), washing of genitals pre coitus and postcoitus by the
woman and her husband (yes/no/sometimes) and other
health/hygiene practices, e.g. direction ofwashing genitals (front to
back/back to front), frequency of changing underwear (number of
times per week), frequency of baths (number of times per week),
drying after voiding urine (yes/no), voluntary delay in voiding urine
(yes/no), how much liquid (> 2/12/< 1 L) drunk per day. The
questionnaire also asked about urological symptoms from the
beginning of pregnancy until the interview; frequency was defined
as total number of daily voids > 8 [10].

meminimalkan bias?
PETUNJUK: Kami mencari
pengukuran, recall atau
bias pengelompokan
Apakah eksposur jelas
dan akurat diukur?
Apakah penulis
menggunakan pengukuran
subjektif atau objektif?
Apakah langkah-langkah
yang benar-benar
mencerminkan apa yang
seharusnya mereka untuk
mengukur? (Apakah
mereka telah divalidasi?)
Apakah metode
pengukuran yang sama
dalam kasus-kasus dan
kontrol?
Apakah penelitian
penyamaran penggabung
yg layak?
Apakah hubungan
temporal yang benar?
(Apakah paparan
mendahului hasilnya?)

6. (a) What confounding


factors have the List:
authors accounted for?
HINT: List the ones you
think might be important,
that The author missed.
Genetic
Environmental
Socio-economic
(b) Have the authors
taken account of the

Yes on page 2-3, first and second paragraph under Methods:


This casecontrol study was performed on 100 women with
positive urine culture (cases) and 150 healthy regnant women
(controls), matched for age, gestational age, parity, occupation and
socioeconomic and education status. The women were selected
consecutively from those attending 5 public clinics at Babol
University of Medical Sciences for prenatal care from 1 January
2002 to 20 February 2004. The exclusion criteria were a history of >
2 episodes of UTI per year, urinary stones or urinary tract anomaly,
chronic disease (diabetes mellitus, sickle-cell anaemia),
consumption of any antibiotic or immune system inhibitory drugs in

potential confounding
factors in the design
and/or in their analysis?
HINT: Look for
Restriction in design,
and techniques e.g.
modelling stratified-,
regression-, or
sensitivity analysis to
correct, control or adjust
for confounding factors

the previous 3 months, or the presence of any abnormal vaginal


discharge.

6. (a) Apa faktor perancu


dari penulis menyumbang
didaftar?
PETUNJUK: Daftar yang
Anda pikir mungkin
penting, yang penulis
melewatkannya.
Genetik
Lingkungan
Sosial-ekonomi
(b) Memiliki penulis
diperhitungkan potensi
faktor pembaur dalam
desain dan / atau dalam
analisis mereka?
PETUNJUK: Carilah
Pembatasan dalam
desain, dan teknik
misalnya pemodelan
stratified-, regression-,
atau analisis sensitivitas
untuk memperbaiki, kontrol
atau menyesuaikan faktor
perancu

7. What are the results of


this study?
HINT: Consider
What are the bottom line
results?
Is the analysis
appropriate to the design?
How strong is the
association between

Yes on page 2, paragraph under Statistical analysis


And Table 2 Association of health and sexual hygiene practices
with urinary tract infection forcases (n = 100) and matched controls
(n = 150) Table 3 Personal hygiene and sexual habits of women
suffering from urinary tract infection (n = 100) and matched controls
(n = 150)

Descriptive statistics and the chi-squared,Fisher exact and t-

exposure and outcome


(look at the odds ratio)?
Are the results adjusted
for confounding, and might
confounding still explain
the association?
Has adjustment made a
big difference to the OR?

tests were used to compare the 2 groups. P < 0.05 was


consideredas significant. A risk profile for UTI was expressed
in the form of odd ratios (OR)with 95% confidence intervals
(CI) for the 250 women.

7. Apa hasil dari penelitian


ini?
PETUNJUK:
Pertimbangkan
Apa hasil bottom line?
Apakah analisisnya tepat
untuk desain?
Seberapa kuat adalah
hubungan antara paparan
dan hasil (melihat rasio
odds)?
Apakah hasil disesuaikan
untuk perancu, dan
mungkin membingungkan
masih menjelaskan
asosiasi?
Apakah penyesuaian
membuat perbedaan besar
dengan OR?
IMPORTANT
(B) What are the results?
(B) Apa hasilnya?
8. How precise are the
results?
How precise is the
estimate of risk?
HINT: Consider
Size of the P-value
Size of the confidence
intervals
Have the authors
considered all the
important variables?
How was the effect of
subjects refusing to

participate evaluated?
8. Bagaimana tepat
hasilnya?
Bagaimana tepat
adalah estimasi risiko?
PETUNJUK:
Pertimbangkan
Ukuran P-nilai
Ukuran interval
kepercayaan
apakah penulis
mempertimbangkan
semua variabel penting?
Bagaimana pengaruh
mata pelajaran menolak
untuk ikut dievaluasi?

9. Do you believe the


results?
HINT: Consider
Big effect is hard to
ignore!
Can it be due to
chance, bias or
confounding?
Are the design and
methods of this study
sufficiently flawed to

1. NNH faktor Not washing genitals Precoitus adalah 7,


Artinya setiap 7 pasien yang Not washing genitals
Precoitus, akan muncul satu kasus ISK pada ibu hamil.
2. NNH faktor Husband not washing genitals precoitus
adalah 8, Artinya setiap 8 pasien yang Husband not
washing genitals precoitus, akan muncul satu kasus ISK
pada ibu hamil.
3. NNH faktor Husband not washing genitals precoitus
adalah 8, Artinya setiap 8 pasien yang Husband not
washing genitals precoitus, akan muncul satu kasus ISK
pada ibu hamil.
4. NNH faktor Not washing genitals postcoitus adalah 2,
Artinya setiap 2 pasien yang Not washing genitals
postcoitus, akan muncul satu kasus ISK pada ibu hamil.
5. NNH faktor Delay in voiding urine (voluntary) adalah 2,
Artinya setiap 3 pasien yang Washing genitals from back
to front, akan muncul satu kasus ISK pada ibu hamil.
6. NNH faktor Not voiding urine postcoitus adalah 2, Artinya
setiap 2 pasien yang Not voiding urine postcoitus, akan
muncul satu kasus ISK pada ibu hamil.
7. NNH faktor Delay in voiding urine (voluntary) adalah 22,
Artinya setiap 22 pasien yang Not voiding urine
postcoitus, akan muncul satu kasus ISK pada ibu hamil.
8. NNH faktor Not drinking plenty of liquids adalah 2, Artinya
setiap 2 pasien yang Not drinking plenty of liquids, akan
muncul satu kasus ISK pada ibu hamil.
Yes on page 4, third paragraph under discussion
Sexual intercourse 3 times per week was associated with greater
frequency of UTI. This association has been reported for sporadic
and recurrent cystitis [13,14,1619]. The mechanical action of
sexual intercourse may facilitate entry of E. coli strains into the
urethra and bladder, because sexual intercourse alters the normal
lactobacillusdominant vaginal flora and facilitate E. coli colonization
of the vagina [20,21]. Uropathogenic E. coli strains may in some
cases be acquired by sexual transmission [22]. These exposures, by
facilitating entry of E. coli into the bladder, may initiate events
leading to UTIs.

make the results


unreliable?
Consider Bradford
Hills criteria (e.g. time
sequence, doseresponse gradient,
strength, biological
plausibility)
9. Apakah Anda percaya
hasilnya?
PETUNJUK:
Pertimbangkan
efek besar sulit untuk
mengabaikan!
Apakah bisa karena
kebetulan, bias atau
membingungkan?
Apakah desain dan
metode penelitian ini
cukup cacat untuk
membuat hasil tidak dapat
diandalkan?
Pertimbangkan kriteria
Bradford Hills (misalnya
urutan waktu, dosisrespons gradien, kekuatan,
landasan biologis)
APPLICABLE
(C) Will the results help locally?
(C) akan hasil membantu secara lokal?
10. Can the results be
applied to the local
population?
HINT: Consider whether
The subjects covered
in the study could be
sufficiently different from
your population
to cause concern
Your local setting is
likely to differ much from
that of the study
Can you quantify the
local benefits and
harms?

Yes hasil penelitian ini bisa kita aplikasi kan pada pasien, faktor2
yang telah diteliti dan terbukti menyebabkan ISK perlu di
komunikasikan dan diedukasikan ke pasien kita terutama faktor
sexual activity.

10. Dapatkah hasil


diterapkan untuk penduduk
lokal?
PETUNJUK:
Pertimbangkan apakah
Subyek tercakup dalam
studi ini bisa menjadi
cukup berbeda dari
populasi Anda
menimbulkan
kekhawatiran
pengaturan lokal Anda
kemungkinan akan
berbeda jauh dari yang
studi
Dapatkah Anda
mengukur manfaat lokal
dan merugikan?
11. Do the results of this
study fit with other
available evidence?
HINT: Consider all the
available evidence from
RCTs, systematic
reviews, cohort studies
and case-control studies
as well for consistency.

Yes. on page 4, Fourth paragraph under discussion


A history of UTI, any and recent, has been a consistently
reported risk factor for subsequent cystitis in both young adult
and postmenopausal women [11,12,14,23,24]. Our study
confirmed that a previous UTI may predispose to subsequent
UTI through behavioural, microbiological or genetic factors.
These findings are consistent with other studies [4,5,25].

11. Apakah hasil penelitian


ini sesuai dengan buktibukti lain yang tersedia?
PETUNJUK:
Pertimbangkan semua
bukti yang tersedia dari
RCT ini, tinjauan
sistematis, penelitian
kohort dan studi kasuskontrol serta untuk
konsistensi.
CONCLUSIONS
VALIDITY
IMPORTANT
APPLICABLE

YES
YES
YES

Remember
One observational study rarely provides sufficiently robust evidence to recommend changes to clinical practice
or within health policy decision making. However, for certain questions observational studies provide the only
evidence. Recommendations from observational studies are always stronger when supported by other
evidence.

Ingat
Satu studi observasional jarang memberikan bukti cukup kuat untuk merekomendasikan perubahan praktek
klinis atau dalam pengambilan keputusan kebijakan kesehatan. Namun, untuk pertanyaan-pertanyaan tertentu
studi observasional memberikan satu-satunya bukti. Rekomendasi dari studi observasional selalu kuat bila
didukung oleh bukti-bukti lainnya.

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