HARM WORKSHEET

Citation:
Barbara de BarrosID, Rachel Pierce , Cathryn Sprenger , Eugene Liat Hui Ong , Stephen L. Walker

Are the results of this harm study valid?

Were there clearly defined groups of Tidak.

patients, similar in all important ways other Kelompok pasien terpilih adalah
than exposure to the treatment or other pasien yang telah terdiagnosis Lepra
cause? dari tahun 2021 dan telah mendapat
vaksin SARS-Cov-2

Were treatments/exposures and clinical Tidak.

outcomes measured in the same ways in both Pasien didapatkan melalui rekam
groups (was the assessment of outcomes medis dan sudah terdiagnosis leprae
either objective or blinded to exposure)? serta sudah terkonfirmasi
mendapatkan vaksin SARS-CoV-2.

Was the follow-up of study patients

sufficiently long and complete? Data pasien didapatkan melalui
rekam medis elektronik dari tahun
2021.
 Do the results satisfy some “diagnostic tests for causation”?
Is it clear that the exposure preceded the
onset of the outcome?
Is there a dose-response gradient?
Is there positive evidence from a
“dechallenge-rechallenge” study?
Is the association consistent from study to
study?
Does the association make biological sense?
Are the valid results from this harm study important?
What is the magnitude of the association
between the exposure and outcome?
What is the precision of the estimate of the
Ya.
Pada pasien yang telah mendapat
vaksin SARS-CoV-2 terlihat
peningkatan dalam kasus lepra
sebesar 98%.
Ya.
Terdapat perbedaan hasil pada setiap
vaksin yang diberikan dan jumlah
dosis yang berbeda.
Tidak.
Pada penelitian ini tidak didapatkan
“dechallenge-rechallenge” study,
dikarenakan subjek mendapatkan
perlakuan yang sama, yaitu
pemberian vaksin SARS-CoV-2 di
dosis yang berbeda.
Tidak.
Penelitian ini merupakan penelitian
pertama yang berhubungan dengan
peningkatan reaksi lepra dan vaksin
COVID 19.
association between exposure and
outcome?

Adverse outcome
Present (case) Absent (control) Totals
Yes a b a+b
(cohort)
Exposed to
the treatment No c d c+d
(cohort)
Totals a+c b+d a+b+c+d

In a randomised trial or cohort study: relative risk = RR = {a/(a+b)}/{c/(c+d)}

In a case-control study: odds ratio (or relative odds) = OR = (a/b) / (c/d) = ad/bc

Should these valid, potentially important results change the treatment of your
patient?

Do the results apply to our patient?

Is our patient so different from those in Tidak.

the study that its results don’t apply?
What are our patient’s risks of the adverse
event?
To calculate the NNH (number of patients
we need to treat to harm one of them) for
any odds ratio (OR) and our patient’s
expected event rate for this adverse event
if they were not exposed to this treatment
(PEER):

What are our patient’s preferences,

concerns and expectations from this
treatment?
What alternative treatments are available?

Additional notes: