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-
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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? • the population studied
Can’t Tell • the intervention given
• the comparator given
No
• the outcomes considered

Comments: Kompleks FCM terdiri dari besi polynuclear (III) hidroksida yang dikomplekskan menjadi
carboxymaltose. Tujuan dari penelitian ini adalah untuk membandingkan efikasi dan keamanan
injeksi FCM dibandingkan dengan zat besi oral dalam pengobatan PPIDA. 425 wanita antara hari
ke-1 sampai hari ke-10 dari persalinan normal dengan anemia sedang (Hb 7-10 g / dl) menjalani tes
skrining di JMMCRI, Thrissur, Kerala. (Abstraks, hal.59)

2. Was the assignment of Yes ✔

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

Comments:
- Berdasarkan pemeriksaan apusan darah perifer dan indeks RBC, 140
subjek dengan anemia defisiensi besi diacak dalam rasio 1: 1 menjadi dua
kelompok. (Bahan dan Metode, hal. 60)

3. Were all of the patients Yes HINT: Consider

✔
who entered the trial • 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: Semua subjek diikuti pada minggu ke-3 dan 6. Pengulangan estimasi Hb dilakukan
pada minggu ke-3 dan 6. Indeks RBC dan parameter serum zat besi diulang pada
minggu ke-6. 97% subyek pada kelompok parenteral dan 76% subyek dalam kelompok
oral telah menyelesaikan penelitian. Data dianalisis sesuai tujuan dari pengobatan.

Is it worth continuing?

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

No

Comments:
Berdasarkan pemeriksaan apusan darah perifer dan indeks RBC, 140
subjek dengan anemia defisiensi besi diacak dalam rasio 1: 1 menjadi dua
kelompok.

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

Comments: Setelah informed consent tertulis, semua subjek menjalani sejarah rinci,
pemeriksaan fisik dan sistemik umum. Subjek kelompok I (n = 70)
menerima subjek FCM intravena dan Kelompok II (n = 70) menerima sulfat
ferous oral.

6. Aside from the experimental Yes

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

No

Comments: Penelitian ini merupakan penelitian prospektif randomisasi terkontrol . - Berdasarkan

pemeriksaan apusan darah perifer dan indeks RBC, 140 subjek dengan anemia defisiensi
besi diacak dalam rasio 1: 1 menjadi dua kelompok. (Bahan dan Metode, hal. 60)

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: Secara signifikan lebih tinggi jumlah wanita dalam kelompok parenteral yaitu mencapai peningkatan Hb> 3
gm / dl (75,7% vs 15,7%, p value <0,001) setelah 6 minggu terapi tetapi perbedaan ini tidak signifikan
secara statistik pada 3 minggu (10,0% vs 2,9%, nilai p 0,085). FCM lebih baik ditoleransi daripada sulfat
besi dengan insiden rendah efek samping gastrointestinal, normalisasi cepat dari tempat penyimpanan zat
besi, kepatuhan yang lebih baik dan masa pengobatan yang lebih singkat. (Abstraks, hal 59)

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

effect? • what are the confidence limits

Comments: Secara signifikan jumlah wanita lebih tinggi pada kelompok parenteral dengan mencapai peningkatan
Hb> 3 gm / dl (75,7% vs 15,7%, p value <0,001) setelah 6 minggu, namn perbedaan ini tidak signifikan
secara statistik pada 3 minggu (10,0% vs 2,9%, nilai p 0,085). (Observasi dan Hasil, hal.60)

Section C: Will the results help locally?

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

✔
the local population, or in • 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: Subjek pasien pasca persalinan dengan anemia sedang (Hb 7-10 g / dl) yang telah
menjalani tes skrining tidak memiliki perbedaan yang signifikan dengan populasi lokal.
Akan tetapi, sediaan infus karboksimaltosa masih terbatas ketersediaanya di Indonesia.

10. Were all clinically important Yes HINT: Consider whether

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

Comments: Subyek dalam kelompok oral memiliki insidensi mual yang secara signifikan lebih tinggi
(20% vs 1,4%; p = 0,001) dan konstipasi (20% vs 1,4%; p = 0,001) dibandingkan kelompok
parenteral. Muntah dan diare hanya terlihat pada kelompok oral. Urtikaria, kram otot dan
disguesia hanya terjadi pada kelompok parenteral.

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

No

Comments: FCM tampaknya menjanjikan untuk PPIDA. FCM lebih baik ditoleransi
daripada sulfat ferrous dengan insiden rendah efek samping
gastrointestinal, normalisasi cepat dari simpanan besi, kepatuhan yang
lebih baik dan masa pengobatan yang lebih singkat.