SKENARIO 1: Critical Appraisal Penelitian Kuantitatif

(RCT, CROSS-SECTIONAL, CASE CONTROL, PRE-POST TEST)

Tujuan Umum :
Mahasiswa memiliki kemampuan untuk menilai secara kritis kesahihan dan kemampu-
terapan informasi kedokteran berbasis bukti (Evidence-Based Medicine) dan menjelaskan
serta memecahkan masalah yang berhubungan dengan masalah konfirmasi tes penyaringan
atau diagnosis penyakit pasien.
Tujuan Khusus :
1. Mahasiswa mampu memahami tahapan telaah kritis dengan menggunakan panduan yang
sesuai, dalam hal ini penelitian kuantitatif
1. Mahasiswa mampu memahami metodologi yang digunakan.
a. bagaimana menentukan populasi dan sample
b. bagaimana menentukan kelompok perlakuan (intervention) atau pembanding (control)
c. memahami cara interpretasi hasil dan pembahasan
d. memahami apa yang dimaksud randomisasi
3. mahasiswa mampu memahami perbedaan diantara ke empat jenis penelitian tersebut
4. Mahasiswa mampu menerapkan kepada rencana penelitiannya.

Sumber: (https://srs-mcmaster.ca/wp-content/uploads/2015/04/Critical-Review-Form-
Quantitative-Studies-English.pdf)
NO CITATION Jara, A., Undurraga, E. A., González, C., Paredes, F.,
SITASI Fontecilla, T., Jara, G., . . . Araos, R. (2021).
Effectiveness of an Inactivated SARS-CoV-2
Vaccine in Chile. New England Journal of Medicine,
385(10), 875–884.

1 STUDY PURPOSE Outline the purpose of the study. How does the
TUJUAN PENELITIAN study apply to your research question?

Was the purpose stated clearly? To identify the effectiveness of an inactivated

SARS-CoV-2 Vaccine in Chile.
Yes
No

2 LITERATURE Describe the justification of the need for this

study.
Was relevant background
literature reviewed? Mass vaccination campaigns to prevent coronavirus
disease 2019 (Covid-19) are occurring in many
Yes countries; estimates of vaccine effectiveness are
No urgently needed to support decision making. A
countrywide mass vaccination campaign with the
use of an inactivated severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) vaccine
(CoronaVac) was conducted in Chile starting on
February 2, 2021.

3 DESIGN Describe the study design. Was the design

appropriate for the study question? (e.g. for
Randomized (RCT) knowledge level about this issue, outcomes,
Cohort ethical issues, etc)
Single case design
Before and after Observational cohort at the national level. The study
Case-control cohort included participants 16 years of age or older
Cross-sectional who were affiliated with Fondo Nacional de Salud
Case study (FONASA), the national public health insurance
program, which includes approximately 80% of the
Chilean population.

Specify any biases that may have been operating

and the direction of their influence on the results

Age, sex, region of residence, income, nationality,

and whether the patient had underlying conditions
that have been associated with severe Covid-19.
These conditions included chronic kidney disease,
 diabetes, cardiovascular disease, stroke, chronic
obstructive pulmonary disease, hematologic disease,
autoimmune disease, human immunodeficiency
virus infection, and Alzheimer’s disease and other
dementias

4 SAMPLE Sampling (who; characteristics; how many; how

was sampling done?). If more than one group,
N = 11,820,292 was there similarity between the group?
Was the sample described in
detail? Participants were at least 16 years of age, were
affiliated with Fondo Nacional de Salud (FONASA;
Yes the national public health care system in Chile), and
No either had received at least one dose of the
CoronaVac vaccine between February 2 and May 1,
Was sample size justified? 2021, or had not received any vaccination. We
excluded persons who had probable or confirmed
Yes coronavirus disease 2019 (Covid-19) according to
No reverse-transcriptase–polymerase-chain-reaction
assay for severe acute respiratory syndrome
coronavirus 2 and all persons who had been
immunized with the BNT162b2 vaccine.

10,187,720 Were included in the final study

population

1. 5,471,728 Were not vaccinated

2. 542,418 Received one dose of vaccine
3. 4,173,574 Received two doses of vaccine

Describe ethics procedures. Was informed

consent obtained?

No

The research protocol was approved by the Comité

Ético Científico Clínica Alemana Universidad del
Desarrollo. The study was considered exempt from
informed consent; no human health risks were
identified.

The study team was entirely responsible for the

design of the study and for the collection and
analysis of the data. The authors vouch for the
accuracy and completeness of the data. The first,
second, and last authors wrote the first draft of the
 manuscript.

5 OUTCOMES Specify the frequency of the outcome

measurement (i.e., pre, post, follow-up)
Were the outcome measures
reliable?
Outcome areas: List measures used:
Yes
No All suspected cases of - Laboratory-confirmed
N/A Covid-19 in Chile are Covid-19.
notified to health - Hospitalization for
authorities by means of Covid-19.
an online platform and - Admission to the ICU
are confirmed by for Covid-19.
laboratory testing. Cases - Covid-19–related death.
of Covid-19 and related
deaths were those in
persons with laboratory-
confirmed infection,
which corresponds to
code U07.1 in the
International
Classification of
Diseases, 10th Revision.

6 INTERVENTION Provide a short description of the intervention

(focus, who delivered it, how often, setting).
Intervention was described in Could the intervention be replicated in practice?
detail?

Yes
No
Not addressed
N/A

Contamination was avoided?

Yes
No
Not addressed
N/A (tidak dilakukan)

Cointervention was avoided?

 Yes
No
Not addressed
N/A

7 RESULTS What were the results? Were they statistically

Hasil significant (i.e., p < 0.05)? If not statistically
significant, was study big enough to show an
Results were reported in terms of important difference if it should occur? If there
statistical significance? were multiple outcomes, was that taken into
account for the statistical analysis?
Yes
No Vaccine effectiveness among partially immunized
Not addressed persons (14 to 28 days after receipt of the first dose)
N/A (tidak dilakukan) was 15.5% (95% CI, 14.2 to 16.8) for the prevention
of Covid-19 and 37.4% (95% CI, 34.9 to 39.9) for
Clinical importance was the prevention of hospitalization, 44.7% (95% CI,
reported? 40.8 to 48.3) for the prevention of admission to the
Apakah kemaknaan klinis ICU, and 45.7% (95% CI, 40.9 to 50.2) for the
dilaporkan? prevention of Covid-19–related death.

Yes In the fully immunized group, the estimated adjusted

No vaccine effectiveness was 65.9% (95% CI, 65.2 to
Not addressed (tidak 66.6) for the prevention of Covid-19 and 87.5%
dijelaskan) (95% CI, 86.7 to 88.2) for the prevention of
hospitalization, 90.3% (95% CI, 89.1 to 91.4) for the
prevention of ICU admission, and 86.3% (95% CI,
84.5 to 87.9) for the prevention of Covid-19–related
death.

8 Were the analysis method(s) What was the clinical importance of the results?
appropriate? Were differences between groups clinically
meaningful? (if applicable)
Yes
No The Results suggest that the CoronaVac vaccine had
Not addressed (tidak high effectiveness against severe disease,
dijelaskan) hospitalizations, and death, findings that underscore
the potential of this vaccine to save lives and
substantially reduce demands on the health care
system.

9 Drop-outs were reported? Did any participants drop out from the study?
Why? (Were reasons given and were drop-outs
Yes handled appropriately?)
No
1,632,572 Were excluded because of probable or
 confirmed Covid-19 before February 2, 2021, or
because they had received the BNT162b2 vaccine.
10 CONCLUSIONS AND What did the study conclude? What are the
IMPLICATIONS implications of these results for practice? What
Simpulan dan Dampaknya were the main limitations or biases in the study?

Conclusions were appropriate The study results suggest that the CoronaVac
given study methods and results vaccine was highly effective in protecting against
severe disease and death.
Yes
No 1. As an observational study, it is subject to
confounding. To account for known confounders, we
adjusted the analyses for relevant variables that
could affect vaccine effectiveness, such as age, sex,
underlying medical conditions, region of residence,
and nationality.

2. Owing to the relatively short follow-up in this

study, late outcomes may not have yet developed in
persons who were infected near the end of the study,
because the time from symptom onset to
hospitalization or death can vary substantially.

3. During the study period, ICUs in Chile were

operating at 93.5% of their capacity on average
(65.7% of the patients had Covid-19). If fewer
persons were hospitalized than would be under
regular ICU operation, the effectiveness estimates
for protection against ICU admission might be
biased downward, and the effectiveness estimates for
protection against death might be biased upward
(e.g., if patients received care at a level lower than
would usually be received during regular health
system operation).

4. Although the national genomic surveillance for

SARS-CoV-2 in Chile has reported the circulation of
at least two viral lineages considered to be variants
of concern, P.1 and B.1.1.7 (or the gamma and alpha
variants, respectively), the study lack representative
data to estimate their effect on vaccine effectiveness.