CASP Randomised Controlled Trial Standard Checklist:

11 questions to help you make sense of a randomised controlled trial (RCT)

Main issues for consideration: Several aspects need to be considered when appraising a randomised
controlled trial:

Is the basic study design valid for a randomised

controlled trial? (Section A)
Was the study methodologically sound? (Section B)
What are the results? (Section C)
Will the results help locally? (Section D)

The 11 questions in the checklist are designed to help you think about these aspects
systematically.

How to use this appraisal tool: The first three questions (Section A) are screening questions about
the validity of the basic study design and can be answered quickly. If, in light of your responses to
Section A, you think the study design is valid, continue to Section B to assess whether the study
was methodologically sound and if it is worth continuing with the appraisal by answering the
remaining questions in Sections C and D.

Record ‘Yes’, ‘No’ or ‘Can’t tell’ in response to the questions. Prompts below all but one of the
questions highlight the issues it is important to consider. Record the reasons for your answers in
the space provided. As CASP checklists were designed to be used as educational/teaching tools in
a workshop setting, we do not recommend using a scoring system.

About CASP Checklists: The CASP RCT checklist was originally based on JAMA Users’ guides to the
medical literature 1994 (adapted from Guyatt GH, Sackett DL and Coaok DJ), nd piloted with
healthcare practitioners. This version has been updated taking into account the CONSORT 2010
guideline (http://www.consort-statement.org/consort-2010, accessed 16 September 2020).

Citation: CASP recommends using the Harvard style, i.e. Critical Appraisal Skills Programme (2020).
CASP (insert name of checklist i.e. Randomised Controlled Trial) Checklist. [online] Available at:
insert URL. Accessed: insert date accessed.

©CASP this work is licensed under the Creative Commons Attribution – Non-Commercial- Share A
like. To view a copy of this licence, visit https://creativecommons.org/licenses/by-sa/4.0/

Critical Appraisal Skills Programme (CASP) part of Oxford Centre for Triple Value Healthcare Ltd www.casp-uk.net

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 Study and citation: .............................................√...........................................................................

Section A: Is the basic study design valid for a randomised controlled trial?
1. Did the study address a clearly Yes No Can’t tell
focused research question?  
CONSIDER: 
Ya
 Was the study designed to assess
the outcomes of an
intervention?
Masalah sangat jelas terfokus, pada
pemberian intervensi Air Kelapa Hijau
(Cocos nucifera L.) untuk
Mengurangi Nyeri Dismenore

 Is the research question ‘focused’ in

terms of:
• Population studied
Dua puluh satu siswa perempuan
berusia 18-24
tahun yang pernah mengalami
dismenore primer dalam satu
siklus menstruasi berpartisipasi dari
Agustus hingga September
2016
• Intervention given
Kelompok eksperimen saya
menerima total 980 hijau
air kelapa di mana 330 ml harus
dikonsumsi setiap 4
jam dalam rentang 12 jam pada satu
hari dismenore
siklus. Kelompok eksperimen II
memperoleh total yang lebih kecil
dosis 490 ml di mana 165 ml harus
dikonsumsi setiap 4 jam
• Comparator chosen
Dua puluh satu siswa perempuan
berusia 18-24
tahun yang pernah mengalami
dismenore primer dalam satu
siklus menstruasi berpartisipasi dari
Agustus hingga September
2016.
• Outcomes measured?
subjek yang dipilih dibagi menjadi
tiga kelompok,
yaitu dosis percobaan I, dosis
percobaan II, dan
kelompok kontrol.
2. Was the assignment of Yes No Can’t tell
participants to interventions   
randomised? CONSIDER: Ya
• How was randomisation carried out?

2
 Dalam Uji Coba Kontrol Acak non-
farmakologis ini
(RCT), subjek yang dipilih dibagi
menjadi tiga kelompok,
yaitu dosis percobaan I, dosis
percobaan II, dan
kelompok kontrol. Dua puluh satu
siswa perempuan berusia 18-24
tahun
• Was randomisation sufficient to
eliminate systematic bias?
Dasar penentuan takaran air
kelapa adalah
miligram magnesium untuk
mengurangi intensitas rasa sakit
pada dismenore
primer. Sebanyak 300 mg
magnesium diperlukan untuk
mengobati dismenore di mana
setiap 100 mg diambil dalam
setiap 4 jam. Kemudian,
proporsi dosis diubah menjadi
ml kelapa
air berdasarkan kandungan
magnesium dan diberikan
kepada
kelompok
pengobatan. Perkebunan tunggal
di Batu, Malang,
Indonesia dipilih untuk
mengurangi kemungkinan bias
dari
variasi kandungan magnesium
tanaman kelapa
• Was the allocation sequence
concealed from investigators and
participants?

3. Were all participants who entered the Yes No Can’t tell

study accounted for at its conclusion?   
CONSIDER: Ya
 Were participants analysed in the 
study groups to which they were
randomised (intention-to-treat
analysis
Uji One Way ANOVA
dilanjutkan dengan uji Post Hoc
dan
dilanjutkan dengan uji
hubungan Pearson Correlation
(IBM®SPSS 20, IBM
Corporation) digunakan sebagai

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 statistik
analisis untuk hasil data Pretest-
Posttest. Pentingnya
tingkat untuk semua
variabel ditetapkan pada
p<0,05.
• Was the study stopped early? If so,
what was the reason?
Tidak

Section B: Was the study methodologically sound?

4. Yes No Can’t tell

 Were the participants ‘blind’ to
intervention they were given?   
Peserta memahami intervensi  
yang diberikan Ya
 Were the investigators ‘blind’ to the 
intervention they were giving to  
participants? TIDAK Ya
 Were the people assessing/analysing 
outcome/s ‘blinded’? TIDAK
5. Were the study groups similar at the start of Yes No Can’t tell
the randomised controlled trial?   
CONSIDER: Ya
 Were the baseline characteristics of each
study group (e.g. age, sex, socio-economic
group) clearly set out?
remaja putri rata-rata berusia 21
tahun
dengan keluhan dismenore
primer. Usia ini masuk
kisaran prevalensi dismenore

 Were there any differences between the

study groups that could affect the
outcome/s?
secara signifikan menunjukkan
pengaruh
air kelapa pada dismenore
pengurangan nyeri pada
kelompok intervensi dibandingkan
dengan kelompok kontrol
(p=0,000). Takaran 330 ml air kelapa
tercatat
nilai perbedaan nyeri terbesar
(VAS=4,14) dibandingkan dengan
kelompok lain

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6. Apart from the experimental intervention, did each Yes No Can’t tell
study group receive the same level of care (that   
is, were they treated equally)?

CONSIDER:
 Was there a clearly defined study protocol?
Dalam Uji Coba Kontrol Acak non-
farmakologis ini
(RCT), subjek yang dipilih dibagi
menjadi tiga kelompok,
yaitu dosis percobaan I, dosis percobaan
II, dan
kelompok kontrol. Dua puluh satu siswa
perempuan berusia 18-24
tahun yang pernah mengalami dismenore
primer dalam satu
siklus menstruasi berpartisipasi dari
Agustus hingga September
2016. Diagnosis dismenore primer
didasarkan pada
dengan kriteria sebagai berikut: a). onset
nyeri pertama subjek
dialami sesaat setelah menarche,
b). panggul bawah atau
sakit perut yang biasanya dikaitkan
dengan onset
aliran menstruasi dan berlangsung 8-72
jam, c). laporan kembali
dan nyeri paha, sakit kepala, diare, mual,
dan muntah
yang mungkin hadir. Penelitian ini tidak
menggunakan uji laboratorium
 If any additional interventions were given (e.g.
tests or treatments), were they similar between
the study groups?
 Were the follow-up intervals the same for
each study group?
330 ml harus dikonsumsi setiap 4
jam dalam rentang 12 jam pada satu hari
dismenore
siklus. Kelompok eksperimen II
memperoleh total yang lebih kecil
dosis 490 ml di mana 165 ml harus
dikonsumsi setiap 4
jam. Sedangkan kelompok kontrol
mendapat air mineral dengan
dosis dan aturan yang sama dengan
kelompok perlakuan 1

Section C: What are the results?

7. Were the effects of Yes No Can’t tell
intervention reported   
comprehensively? Ya
CONSIDER:
• Was a power calculation
undertaken?
Pengaruh air kelapa pada dismenore
pengurangan nyeri dinilai susah di
berikan dan sebelum
• What outcomes were measured, and
were they clearly specified?
• How were the results expressed?
For binary outcomes, were relative
and absolute effects reported?
Hasil uji ANOVA secara signifikan
menunjukkan pengaruh
air kelapa pada dismenore
pengurangan nyeri pada
kelompok intervensi dibandingkan
dengan kelompok kontrol
(p=0,000). Takaran 330 ml air kelapa
tercatat
nilai perbedaan nyeri terbesar
(VAS=4,14) dibandingkan dengan
kelompok lain (Tabel 1). Nilai tinggi
ini membuktikan bahwa
dosis adalah dosis yang paling efektif
untuk mengurangi
nyeri dismenore.

• Were the results reported for

each outcome in each study group at
each follow-up interval?
kelompok. Dosis 330 ml
menunjukkan penurunan yang nyata
dari
nyeri daripada kontrol (p=0,000)
dibandingkan dengan yang lain
Sedangkan saat diuji,
kelompok dosis efektif juga memiliki
perbedaan yang signifikan
antar kelompok dalam mengurangi
nyeri dismenore
(p=0,002).
Tabel 2. Uji Post Hoc
Selanjutnya, hubungan yang sangat
kuat antara
dosis efektif air kelapa hijau dan
dismenore
pengurangan rasa sakit dibuktikan
dengan nilai Pearson
korelasi (r=0,816) (Tabel 3). Ini
 berarti kelapa hijau
air adalah faktor 66,7% yang
menjelaskan pengurangan nyeri
pada
primer dismenore.

kelompok dosis (p=0,124)

table 2 ,
• Was there any missing or incomplete
data? lengkap
• Was there differential drop-out between the
study groups that could affect the
results?YA
• Were potential sources of bias identified? YA
• Which statistical tests were used? YA
• Were p values reported? YA
8. Was the precision of the estimate of the Yes No Can’t te
intervention or treatment effect reported?   
Ya
CONSIDER:
• Were confidence intervals (CIs) reported? YA
Dalam analisis data retrospektif
menggunakan perangkat lunak setelah
pengumpulan data daya dihitung sebagai
100%untuk masing masing kelompok
9. Do the benefits of the experimental Yes No Can’t tel
intervention outweigh the harms and costs?   
Ya
CONSIDER:
 What was the size of the intervention or
treatment effect?
 Were harms or unintended effects
reported for each study group?
 Was a cost-effectiveness analysis
undertaken? (Cost-effectiveness analysis
allows a comparison to be made between
different interventions used in the care of the
same condition or problem.)
Pemberian magnesium dan kalsium
pada usia muda
wanita yang menderita dismenore
terbukti memiliki
efek pengurangan rasa sakit yang
lebih kuat daripada kalsium saja (-1,9
95% CI -2.2 hingga -1.7, p<0.001 vs.
-0.9 95% CI -1.2 hingga -0.6,
p<0,001) (29). Perkiraan total
magnesium (Mg) dari
dosis efektif adalah sekitar 297 mg
dihitung dari satu hari
administrasi. Meskipun jumlah ini
sedikit lebih sedikit
dari jumlah yang disarankan (300
mg) untuk dikurangi
nyeri dismenore (300 mg) (33), tetapi
dosis dalam
penelitian telah terbukti memiliki
efek yang sama.
Magnesium tidak dapat secara
langsung mengurangi jumlah
prostaglandin yang diproduksi dalam
jumlah besar selama
dismenore. 
 Section D: Will the results help locally?

10. Can the results be applied to your local Yes N Can’t

population/in your context?  o tell
ya  
CONSIDER:
• Are the study participants similar to the
people in your care?
• Would any differences between your
population and the study participants alter the
outcomes reported in the study?
Pesertas study serupa dengan remaja yang
mengalami nyeri pada saat halangan
sehingga hasilnya dapat kami terapkan
dan kontek kesehatan reproduksi remaja di
fasilitas pelayanan pertama
Are the outcomes important to your population?
remaja putri rata-rata berusia 21 tahun
dengan keluhan dismenore primer.
• Are there any outcomes you would have
wanted information on that have not been
studied or reported?
Manfaat mengurangi diminore pada
remaja
• Are there any limitations of the study that
would affect your decision? tidak
11. Would the experimental intervention provide Yes No Can’t
greater value to the people in your care than any   tell
of the existing interventions? Ya 
CONSIDER:
 What resources are needed to introduce this
intervention taking into account time, finances,
and skills development or training needs?
Air kelapa hijausumber alam yang
mudah di dapatkan , non investasi hemat
biaya dan aman
 Are you able to disinvest resources in one or
more existing interventions in order to be
able to re-invest in the new intervention?
Keberhasilan penerapan intervensi di
populasi lokal harus di dukung oleh lintas
sektor yang terkait

APPRAISAL SUMMARY: Record key points from your critical appraisal in this box. What is your
conclusion about the paper? Would you use it to change your practice or to recommend changes
to care/interventions used by your organisation? Could you judiciously implement this intervention
without delay?
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