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 Cook DJ), and 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.

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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 focused Yes No Can’t tell

research question? o
✔ o
CONSIDER:
P : The participants were 12 years of age or older and had newly diagnosed pulmonary tuberculosis that was confirmed on
culture to be susceptible to isoniazid, rifampin, and fluoroquinolones
I : The rifapentine regimen involved 8 weeks of once-daily rifapentine, isoniazid, pyrazinamide, and ethambutol followed

Was the study designed to assess the outcomes by 9 weeks of once-daily rifapentine and isoniazid.
The rifapentine–moxifloxacin regimen involved 8 weeks of once-daily rifapentine, isoniazid, pyrazinamide, and

of an intervention? moxifloxacin followed by 9 weeks of once-daily rifapentine, isoniazid, and moxifloxacin

C : . The control regimen involved 8 weeks of once-daily rifampin, isoniazid, pyrazinamide, and ethambutol followed by 18

Is the research question ‘focused’ in terms of:

weeks of once-daily rifampin and isoniazid
O : The primary efficacy outcome was survival free of tuberculosis at 12 months after randomization (see the
Supplementary Appendix). The primary safety outcome was an adverse event of grade 3 or higher with an onset during

• Population studied
the on-treatment period (defined as the period during which the trial medications were administered and up to 14 days
after the last dose

• Intervention given
• Comparator chosen
• Outcomes measured?

2. Was the assignment of participants to Yes No Can’t tell

interventions randomised? o
✔ o o
CONSIDER: The participants were randomly assigned in a
• How was randomisation carried out? Was 1:1:1 ratio to one of three regimens with the use
the method appropriate? of a central Web-based system and the “big
• Was randomisation sufficient to eliminate stick”design by Soares and Wu,26 with a
systematic bias? maximum allowable imbalance of two (Fig. S1 in
• Was the allocation sequence concealed the Supplementary Appendix)
from investigators and participants?

3. Were all participants who entered the study Yes No Can’t tell
accounted for at its conclusion? o✔ o o
CONSIDER: - adanya pasien yyang lost to follow up,
• Were losses to follow-up and exclusions adanya perbedaan jumlah antara yang
after randomisation accounted for?
• Were participants analysed in the study dirandom dengn yg dianalisis/populasi
groups to which they were randomised - menggunakan metode intention to
(intention-to-treat analysis)? treat analysis maka semua partisipasi
• Was the study stopped early? If so, what ikut hingga akhir
was the reason? - studi tidak dihentikan lebih awal

Section B: Was the study methodologically sound?

4. Yes No Can’t tell

• Were the participants ‘blind’ to
intervention they were given?
• Were the investigators ‘blind’ to the
intervention they were giving to
participants?
• Were the people assessing/analysing
outcome/s ‘blinded’?
o o
✔ o
o
✔ o
o
✔ o o

5. Were the study groups similar at the start of Yes No Can’t tell
the randomised controlled trial? o✔ o o
CONSIDER: karena ". The baseline demographic
• Were the baseline characteristics of each and clinical characteristics of the
study group (e.g. age, sex, socio-economic
group) clearly set out? participants were similar in the three
• Were there any differences between the treatment groups (Table 1)." dilihat dari
study groups that could affect the angka baseline hampir sama jadi bisa
outcome/s? dikatakan ke-2 kelompok mirip

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6. Apart from the experimental intervention, did
each study group receive the same level of
care (that is, were they treated equally)?
CONSIDER:
• Was there a clearly defined study protocol?
• 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?
Section C: What are the results?
7. Were the effects of intervention reported
comprehensively?
CONSIDER:
• Was a power calculation undertaken?
• What outcomes were measured, and were
they clearly specified?
• How were the results expressed? For
binary outcomes, were relative and
absolute effects reported?
• Were the results reported for each
outcome in each study group at each
follow-up interval?
• Was there any missing or incomplete data?
• Was there differential drop-out between the
study groups that could affect the results?
• Were potential sources of bias identified?
• Which statistical tests were used?
• Were p values reported?
8. Was the precision of the estimate of the
intervention or treatment effect reported?
CONSIDER:
• Were confidence intervals (CIs) reported?
9. Do the benefits of the experimental
intervention outweigh the harms and costs?
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.)
Yes No Can’t tell
o o o
✔
Rifapentine was administered at a daily dose of 1200
mg, and moxifloxacin at a daily dose of 400 mg.Other
drugs were administered at standard doses adjusted
for body weight (Table S1). Because food affects the
absorption of rifapentine and rifampin differently,
rifapentine was administered within 1 hour after in
gesting food, and rifampin was administered on an
empty stomach
Follow up intervals the sam for each study group "The
total duration of follow-up was 18 months."
Yes No Can’t tell
o o o
outcome pada tabel 2 dan 3
follow up interval 12 bulan
los to follow up pada tabel 1
Yes No Can’t tell
o o o✔
karena Cls reported hanya pada
unfavorbale outcome, tidak ada
penjelasn Cl pada masing-masing
outcome di tabel 2
Yes No Can’t tell
o o
✔ o
-Between the rifapentine-moxifloxacin group and the control group, non inferiority
was confirmed in both analysis populations. The rifapentine regimen was not
shown to be noninferior to the control regimen in either analysis population.
- No evidence was found of a difference in the percentage of participants who
had an adverse event of grade 3 or higher (the primary safety outcome) during
the on-treatment period between the rifapentine–moxifloxacin group and the con
trol group (18.8% [159 participants] vs. 19.3% [159]; adjusted difference, −0.6
percentage points; 95% CI, −4.3 to 3.2) (Table 3 and Table S7). The percentage
of participants who had an adverse event of grade 3 or higher during the on-treat
ment period was lower in the rifapentine group (14.3% [119 participants]) than in
the control group (adjusted difference, −5.1 percentage points; 95% CI, −8.7 to
−1.5). All-cause mortality during the on-treatment period was similar across the
treatment regimens (7 participants [0.8%] in the control group, 3 [0.4%] in the
rifapentine–moxifloxacin group, and 4 [0.5%] in the rifapentine group) (Tables 3,
Tables S8 through S10, and Fig. S8).
-Finally, drug costs may be higher for the rifapentine–moxifloxacin regimen than
for the current standard 6-month regimen, at least in the short term
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 Section D: Will the results help locally?

10. Can the results be applied to your local Yes No Can’t tell
population/in your context? o o o
✔

"Between January 25, 2016, and October 30,

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?
• Are the outcomes important to your
population?
• Are there any outcomes you would have
wanted information on that have not been
studied or reported?
• Are there any limitations of the study that
would affect your decision?
2018, a total of 5124 patients underwent
screening at 34 trial sites in Brazil, China
(Hong Kong), Haiti, India, Kenya, Malawi,
Peru, South Africa, Thailand, Uganda, the
United States, Vietnam, and Zimbabwe, and
2516 were randomly assigned to a treatment
group." = tidak ada penjelasaan apakah
perbedaan pastisipasi ini mempengaruhi
outcome.

11. Would the experimental intervention provide Yes No Can’t tell

greater value to the people in your care than o
✔ o o
any of the existing interventions? hasil penelitian ini, regimen 4 bulan
Rifapentine-Moxifloxcacin non inferior
CONSIDER: terhadap kontrol dengan efek samping yang
• What resources are needed to introduce hampir sama dengan kontrol sehingga
this intervention taking into account time, memberikan greater value daripada standar
finances, and skills development or training regimen 6 bulan karena bisa mempersingkat
needs? terapi. Namun cost yang dikelurgan lebih
• Are you able to disinvest resources in one banyak sehingga untuk di Indonesia belum
or more existing interventions in order to ada CEA
be able to re-invest in the new
intervention?

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?