CASP Checklist: 11 questions to help you make sense of a Randomised Controlled Trial

How to use this appraisal tool: Three broad issues need to be considered when appraising a
trial:

Are the results of the study 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 three 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’t 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.

About: These checklists were designed to be used as educational pedagogic tools, as part of a
workshop setting, therefore we do not suggest a scoring system. The core CASP checklists
(randomised controlled trial & systematic review) were based on JAMA 'Users’ guides to the
medical literature 1994 (adapted from Guyatt GH, Sackett DL, and Cook DJ), and piloted with
health care practitioners.
For each new checklist, a group of experts were assembled to develop and pilot the checklist
and the workshop format with which it would be used. Over the years overall adjustments
have been made to the format, but a recent survey of checklist users reiterated that the basic
format continues to be useful and appropriate.
Referencing: we recommend using the Harvard style citation, i.e.: Critical Appraisal Skills
Programme (2018). CASP (insert name of checklist i.e. Randomised Controlled Trial) Checklist.
[online] Available at: URL. Accessed: Date Accessed.

©CASP this work is licensed under the Creative Commons Attribution – Non-Commercial-
Share A like. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-
sa/3.0/ www.casp-uk.net

Critical Appraisal Skills Programme (CASP) part of Oxford Centre for Triple Value Healthcare Ltd www.casp-uk.net
Paper for appraisal and reference:............................................................................................................
Section A: Are the results of the trial valid?

1. Did the trial address a clearly Yes HINT: An issue can be ‘focused’ In terms of
focused issue?
俵 • the population studied
Can’t Tell • the intervention given
• the comparator given
No
• the outcomes considered

Comments:
Penelitian dilakukan pada pasien yang didiagnosis kanker prostat yang telah menjalani prostatektomi
dan diklasifikasikan menurut tumor classification dan Gleason score post-surgery.

intervensi yang di berikan telah sesuai standar menurut parameter masing-masing variabel.

2. Was the assignment of Yes HINT: Consider

patients to treatments
俵 • how this was carried out
randomised? Can’t Tell • was the allocation sequence concealed
from researchers and patients
No

Comments:
Penelitian ini menggunakan randomize control trial, dimana pasien diminta untuk memilih nomer
tertentu secara random yang mewakili intervensi apa yang akan mereka jalani. penelitian ini juga
dilakukan secara real-life time

3. Were all of the patients Yes HINT: Consider

who entered the trial
俵 • was the trial stopped early
properly accounted for at Can’t Tell • were patients analysed in the groups to
its conclusion? which they were randomised
No

Comments:
Seluruh pasien mengikuti prosedur penelitian dan dievaluasi sejak awal hingga akhir. Semua
karakteristik dan parameter masing-masing variabel di nilai sesuai dengan standar.

Is it worth continuing?

2
4. Were patients, health Yes
workers and study personnel
俵
‘blind’ to treatment? Can’t Tell

No

Comments:
pasien dan investigators tidak mengetahui hingga analisis statistic dilakukan (hal.673)

5. Were the groups similar at Yes HINT: Consider

the start of the trial • other factors that might affect the
Can’t Tell outcome, such as; age, sex, social class

No
俵

Comments:

Subyek penelitian ini bervariasi dengan rata-rata usia kelompok yaitu 62 dan 64 tahun serta tidak
membedakan jenis kelamin.

6. Aside from the experimental Yes

intervention, were the groups 俵
treated equally?
Can’t Tell

No

Comments:
seluruh pasien mendapatkan intervensi yang sama sesuai dengan subgrubnya dan seluruh grup
mendapatkan perlakuan yang sama dalam pengukuran variabel yang dinilai.

Section B: What are the results?

3
7. How large was the treatment effect? HINT: Consider
• what outcomes were
measured
• Is the primary outcome clearly
specified
• what results were found for
each outcome

Comments: Pada kelompok yang mendapat intervensi dengan tomat dibanding dengan kontrol grup dengan
resiko sedang menurut tumor classification dan Gleason score post-surgery didapatkan adanya penurunan kadar
PSA yang signifikan (-2.9% dan +6.5% , p =0.016). Selain itu, nilai tengah kadar PSA pasien menurun 1% seiring
dengan peningkatan tertinngi kadar lycopene,selenium dan C20:5 n-3 fattyacid dalam plasma dengan nilai p=0.003.
Penurunan kadar PSA juga terjadi pada pasien yang memiliki peningkatan tertinggi kadar lycopene saja dalam
plasmanya.

8. How precise was the estimate of the treatment HINT: Consider

effect? • what are the confidence limits

Comments:
Hasil penelitian memiliki nilai yang signifikan dengan p<0.05

Section C: Will the results help locally?

9. Can the results be applied to Yes HINT: Consider whether

the local population, or in
俵 • the patients covered by the trial are
your context? Can’t Tell similar enough to the patients to whom
you will apply this
No • how they differ

Comments:
hasil penelitian mungkin dapat diaplikasikan di negara lain. harus dilakukan standarisasi kandungan tomat di
negara atau populasi lain untuk menerapkan hasil penelitian ini dikarenakan standarisasi dari kadar lycopene
dalam tomat yang diterapkan di pasaran norwegia berbeda dengan negara lain. (hal.677)

10. Were all clinically important Yes HINT: Consider whether

outcomes considered?
俵 • there is other information you would
Can’t Tell like to have seen
• if not, does this affect the decision
No

Comments:
pada penelitian ini menggunakan kadar lycopene 30mg. mungkinkah dilakukan dengan perbandingan kadar
lycopene yang berbeda dalam beberapa kelompok untuk melihat efek penurunannya apakah lebih baik atau tidak.

4
11. Are the benefits worth the Yes HINT: Consider
harms and costs? 俵 • even if this is not addressed by the
Can’t Tell trial, what do you think?

No

Comments:
pada penelitian ini tidak menyebutkan efek samping yang timbul. penelitian ini menyebutkan efek penurunan kadar
PSA pada pasien yang mengkonsumsi tomat yang mengandung lycopene 30mg/hari dapat menurunkan resiko
kanker prostat dan hal ini mudah diaplikasikan dalam diet untuk pasien kanker prostat