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Tugas Mata Kuliah Komunikasi dan Konseling

Program Profesi Apoteker, Fakultas Farmasi, Universitas Jember

Critical Review of A Pharmacoepidemiology Study

Angkatan VII Semester, TA Genap, 2017/2018

Anggota kelompok (NIM) 1. 2.
3. 4.
5. 6.
Judul artikel
Tautan (link URL)
Penulis Tahun
publikasi
Nama Jurnal
Kesimpulan

Reference (if any)

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This rubric is developed based on Blommel, ML, Abate, MA, 2007, A Rubric to Assess Critical Literature Evaluation Skills, American Journal of
Pharmaceutical Education, 71 (4) Article 63
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Page of article showing the quote or evidence of your answer
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RUBRIC§

PARTS OF ARTICLE QUOTES PAGE§§ COMMENTS

Authors/Introduction
If potential conflicts of interest exist, did “This trial was supported by a grant from the Brazilian National AIDS Program-
Ministry of Health. We thank Abbott Laboratories who donated lopinavir, ritonavir, 2892 Tidak, karena Abbott hanya memberikan bahan berupa
they appear to influence the study’s and internal standard for the pharmacokinetics assay”
(9) lopinovir, ritonavir, dan standar dari metode
objective, methods, or conclusions?
farmakokinetik
Was an appropriate scientific background “The number of women infected by the human immunodeficiency virus (HIV)
worldwide has gradually increased in recent years (1). The majority of these women 2884 Infeksi HIV pada wanita meningkat setiap tahun, dan
and rationale provided? are of reproductive age,which increases the risk of HIV mother-to-child transmission
(1) terdapat resiko penurunan penyakit terhadap janin.
(MTCT). The use of lopinavir coformulated with ritonavir (LPV/r) during pregnancy is
recommended in the majority of HIV treatment guidelines. ” Penggunaan lopinavril yang diformulasikan dengan
ritonavir direkomendasikan untuk terapi HIV selama
masa hamil.
Is the stated objective or hypothesis
consistent with the research question that
needed to be addressed?
Methods—Design
Is study design appropriate and optimal to
fulfill objective/hypothesis?
Was method used to assign patients to
treatment groups appropriate and clearly
described?
Were all involved with study appropriately
blinded? Was success of blinding
determined? Was unblinding unlikely?
Methods—Patients/Subjects
Were there any problems with how or from
where patients were enrolled?
Were the inclusion and exclusion criteria
appropriate and representative of the
population of interest? What additional
criteria, if any, would have strengthened the
study?
How was sample size determined? Was the
initial sample size adequate for each
primary outcome measure?
Methods—Treatment Regiments

§
This rubric is developed based on Blommel, ML, Abate, MA, 2007, A Rubric to Assess Critical Literature Evaluation Skills, American Journal of
Pharmaceutical Education, 71 (4) Article 63
§§
Page of article showing the quote or evidence of your answer
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PARTS OF ARTICLE QUOTES PAGE§§ COMMENTS

If an active control used, was it an
appropriate selection?
Were the study drug(s) and any active
control(s) dosed and administered
appropriately and in a comparable manner?
Were the drug(s) administered for a
sufficient duration?
Were the different groups handled similarly
except for treatments studied?
Methods—Outcome Measures
Were primary and secondary outcome
measures clearly defined? Were any
methods needed to enhance their quality
(e.g., training of investigators or patients,
standardization among multicenter sites,
etc.) and were these performed?
Were outcome measures appropriate and
optimal given the study objective?
Was timing of outcome measurements
appropriate and of adequate frequency and
duration?
Methods—Data Handling
Was it clear how many patients were in
each analysis? Did the data handling
method used significantly affect
interpretation of study findings?
Was the number of patients accounted for
at each step of the study? Could the reasons
for dropout affect the clinical usefulness of
therapy?
Methods—Statistics
Were appropriate statistical tests used for
all primary outcomes? Were secondary
outcomes analyzed appropriately?
Was the power appropriate for all primary
and secondary outcome analyses,
considering dropouts? If subgroup analyses
performed, was power sufficient?
§
This rubric is developed based on Blommel, ML, Abate, MA, 2007, A Rubric to Assess Critical Literature Evaluation Skills, American Journal of
Pharmaceutical Education, 71 (4) Article 63
§§
Page of article showing the quote or evidence of your answer
 4

PARTS OF ARTICLE QUOTES PAGE§§ COMMENTS

Results
Were any significant differences apparent
among groups at baseline that could
influence study results?
Were results reported for each measure
described in Methods section?
Were the measure(s) of variability used
appropriate and sufficient?
Were findings statistically and clinically
significant?
Was Type II error likely for non-statistically
significant findings?
Was compliance addressed and could this
have influenced study results?
Were there factors (e.g., study setting, diet,
other confounding variables) besides the
treatments used that could have affected
the results observed? If so, were they
accounted for or controlled for in the study?
Were differences in adverse effects among
groups statistically analyzed?
Discussion/Conclusion
Were results interpreted appropriately by
authors?
Did authors adequately explain key study
limitations and any discrepancies from other
similar studies?
Were authors’ conclusions consistent with
the results and study limitations and
extrapolated appropriately?
©2005, 2006 West Virginia University School of Pharmacy (Abate MZ, Blommel ML)

§
This rubric is developed based on Blommel, ML, Abate, MA, 2007, A Rubric to Assess Critical Literature Evaluation Skills, American Journal of
Pharmaceutical Education, 71 (4) Article 63
§§
Page of article showing the quote or evidence of your answer