CRITICAL APPRAISAL FOR THERAPY ARTICLE

Judul studi : Azithromycin versus standard care in patients with mild-to-moderate COVID-19 (ATOMIC2): an open-label, randomised trial
Jenis studi : RCT

Kelompok yang melakukan appraisalpertama (A) :1

Kelompok yang melakukan appraisal kedua (B) :2

Checklist:
Item Kel. A Kel. B
Did the study address a clearly focused research question? (PICO) Yes (Abstract & the last paragraph of
“Introduction”).
P = Adults patients with mild-to-
moderate COVID-19
I = Azithromycin + standard care
C = Standard care
O = death or hospital admission
from any cause over the 28 days
from randomisation
Internal validity
Was the assignment of participants to interventions randomised? Yes (“Randomisation & masking”).
Web-based automated service, with a
minimisation algorithm to ensure
balanced allocation across treatment
groups, stratified by centre, sex, and
presence of hypertension and diabetes.
Were measures objective or were the patients/investigators/people No (first sentence in “Study design” and
analyzing the outcome kept “blind” to which treatment was being last sentence in “Randomisation &
received? masking”).
The study is open-label (not blinded),
but the primary outcome is objective.
Were the study groups similar at the start of RCT? Yes.
Table 1 and in”Results” paragraph 2.
Were all participants who entered the study accounted for at its Yes (last paragraph in “Statistical
conclusion? Were they analysed in the groups to which they were analysis & protocol changes” and
randomized/“intention-to-treat” analysis? Figure 1).
ITT analysis is used.
Drop out rate is 0.01% in azithromycin
group and 0.01% in standard care group.
The drop out rate is similar in the two
groups.
Apart from the experimental intervention, did each study group Yes.
receive the same level of care? (“Procedures”, paragraph 2.
Importance
What outcomes were measured, and were they clearly specified? Yes. (“Outcomes”)
(Tuliskan Primary outcome saja) The primary outcome was the
proportion of participants with hospital
admission or death from any cause
within 28 days from randomisation.
Yes, they are clearly specified.
How were the results expressed? (hanya untuk primary outcome) OR, RD, dan HR (Table 2)
What was the size of the intervention or treatment effect? (hanya (Table 2)
untuk primary outcome dan jelaskan interpretasinya.) Untuk primary outcome Hospitalization
or death from any cause in 28 days:
OR = 0,91 (95%CI 0,42-1,97), p = 0,82.
RD = -1,2% (95%CI -8,2-5,7)
HR = 0,99 (95%CI 0,49-2,00), p = 0,99.

Based on the OR and HR values,

azithromycin plus standard care does
not significantly reduce the risk of
hospitalization or death from any-cause
in 28 days compared to standard care
alone in adult patients with mild-to-
moderate COVID19.
Based on the RD value, azithromycin
plus standard care does not significantly
reduce the proportion of hospitalization
or death from any-cause in 28 days
 compared to standard care alone in adult
patients with mild-to-moderate
COVID19.

NNT is not counted, since the RD value

is not significantly different.
Were potential sources of bias identified? Yes (Table 2).
Adjusting factors are centre,
hypertension, diabetes, sex, age 65 years
and older, presence of chronic lung
disease, and treatment for cancer.
Were harms or unintended effects reported for each study group? Yes. (“Results”, last paragraph).
Relevance
Are the study participants similar to the people in my care? Yes. (“Participants”)
Is the treatment feasible in my setting? Is the comparator used in my Yes. (“Procedures, paragraph 2)
setting?
Are the outcomes important to my population? Yes. (“Outcomes”)
Are there any outcomes I would have wanted information on that No.
have not been studied or reported?
Will the potential benefits of treatment outweigh the potential harms Yes.
of treatment for my patient?
Are there any limitations of the study that would affect my decision? No. (“Discussion, paragraph 6)
Would the experimental intervention provide greater value (cost- Unknown.
effectiveness) to the people in my care than any of the existing
interventions?

Conclusion:
The study has a clearly focused question, has internal validity, the results are important, and relevant to my practice..
Results of the study showed that azithromycin plus standard care does not significantly reduce the risk and proportion of hospitalization or death from any-
cause in 28 days compared to standard care alone in adult patients with mild-to-moderate COVID19.