CRITICAL APPRAISAL FOR THERAPY ARTICLE

Judul studi : Effects of dapagliflozin on mortality in patients with chronic kidney disease: a pre-specified analysis from the DAPA-CKD
randomized controlled trial
Jenis studi : RCT

Kelompok yang melakukan appraisalpertama (A) : 10

Kelompok yang melakukan appraisal kedua (B) :-

Checklist:
Item Kel. 10 Kel. B
Did the study address a clearly focused research question? (PICO) Yes.
P (patient): patients with chronic kidney
disease
I (intervention) = dapagliflozin
C (comparison) = placebo
O = mortality caused of
cardiovascular, non-cardiovascular,
and undeterminate cause of death
Internal validity
Was the assignment of participants to interventions randomised? Yes.
Participants were randomized in a 1:1
ratio to dapagliflozin 10 mg/day
or matched placebo and followed for a
median of 2.4 years (25th–75th
percentile, 2.0–2.7 years)
Were measures objective or were the patients/investigators/people Yes.
analyzing the outcome kept “blind” to which treatment was being DAPA-CKD was a multicentre, double-
received? blind, placebo-controlled,
randomized trial conducted at 386 study
sites in 21 countries.
Study personnel (except the Independent
Data
Monitoring Committee) and participants
 were blinded to treatment allocation
Were the study groups similar at the start of RCT? Yes.
Results section in patient-characteristics
subsection paragraph 1.
Were all participants who entered the study accounted for at its Yes.
conclusion? Were they analysed in the groups to which they were Pada penelitian didapatkan drop out rate
randomized/“intention-to-treat” analysis? 0,01% dari dua kelompok
Apart from the experimental intervention, did each study group Yes.
receive the same level of care? Methode section in trial design and study
participants subsection paragraph 2.
Importance
What outcomes were measured, and were they clearly specified? The primary composite endpoint was the
(Tuliskan Primary outcome saja) time to first occurrence of a
sustained decline in eGFR of at least
50%, onset of end-stage kidney dis ease,
or death from kidney or cardiovascular
causes
Yes, they are clearly specified.
How were the results expressed? (hanya untuk primary outcome) HR
What was the size of the intervention or treatment effect? (hanya Untuk primary outcome mortality
untuk primary outcome dan jelaskan interpretasinya.) caused of cardiovascular, non-
cardiovascular, and undeterminate
cause of death
HR = 0,69 (95%CI 0,53-0,88), p =
0,003.

Berdasarkan nilai HR, dapagliflozin

secara signifikan menurunkan tingkat
mortalitas yang disebabkan karena
penyakit cardiovascular, non-
cardiovascular, maupun penyebab lain
yang tidak diketahui,

NNT: 1/0,69= 1,449

Were potential sources of bias identified? Yes.
The
comparison of cardiovascular and non-
cardiovascular deaths in
patients with or without dialysis may be
biased and should be carefully
interpreted as patients with
cardiovascular instability due to under
lying cardiovascular disease might not
be expected to start dialysis
Were harms or unintended effects reported for each study group? Yes.
Discussion section, fifth paragraph.
Relevance
Are the study participants similar to the people in my care? Yes
Is the treatment feasible in my setting? Is the comparator used in my No
setting?
Are the outcomes important to my population? Yes.
Are there any outcomes I would have wanted information on that have Yes.
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? Yes.
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 probably relevant to my practice..
Results of the study showed that in patients with CKD, dapagliflozin prolonged survival irrespective of baseline patient characteristics. The
benefits were driven largely by reductions in non-cardiovascular death.

Kelompok 10:
1. 51_Muhammad Fajrurrahman_1910911210039
2. 79_Binta Nur A'isyah_1910911220031
3. 80_Noradzkia Humairah_1910911220032
4. 88_Salsabila Qothrunnada_1910911220045
5. 97 _Yowan Maulidi_1910911310008
6. 124_Syafina Dwiayu Ardelia Rudiansyah_1910911320011
7. 128_Viren Lolita Aranda_1910911320020
8. 133_Gusti Marethasanda Syifa Ananda_1910911320028