4. Do the authors give sufficient background information for the study? Did they
demonstrate that the study was important and ethical?
(Ya, penulis menjelaskan latar belakang dan informasi yang penting dari
penelitian yaitu ototoksisitas dari aminoglikosida dapt terjadi pada
penggunaan 6 minggu. Ototoksisitas dapat terjadi secara perlahan dan dapat
menyebabkan permanen)
5. Are the purpose and the objectives clearly stated and free from bias? (Ya,
memiliki tujuann dan objek penelitian yang jelas yaitu pasien terapi intensif
dengan resisten tuberkulosis yang di injeksi aminoglikosida)
6. Was the study approved by an investigational review board? (Ya, pada komite
etik dari Sacred Heart Hospital)
7. Does the investigator state the null hypothesis? Is the alternative hypothesis
stated?
8. Is the sample size large enough? Is the sample representative of the population?
9. Are the inclusion and exclusion criteria clearly stated, and are they appropriate
?
(Peneliti, tidak menuliskan dalam jurnal menegenai kriteria inklusi dan eklusi,
tetapi peneliti menjelaskan parameter klinik dan demografi untuk menjelaskan
hubungan pasien dengan ototoksik
10. Was the study randomized correctly? Even if the study is adequately
randomized, are the groups (treatment and control) equivalent ?
(peneliti tidak menjelaskan studi random, tetapi peneliti menjelaskan hanya
menggunakan sampel pada pasien yang didiagnosa resisten TBC)
11. What is the study design? Is it appropriate? (Studi yang dilakukan adalah
analisis prosfektif pada pasin yang fase intensif terapi resisten obata TBC)
12. Was the study adequately controlled? Were the controls adequate and
appropriate ?
(ya, penelitian ini hanya dilakukan pada penderita TBC yang resisten obat)
14. Were appropriate doses and regimens used for the disease state under study?
(Ya, dosis dan regimen berdasarkan Guideline dari WHO)
15. Was the length of the study adequate to observe outcomes? (Ya, penelitian
dilakukan dari Januari hingga Desember 2015 sesuai dengan terapi intensif
yaitu 8 bulan)
16. If the study is a crossover study, was the washout period adequate ?
(Peneliti tidak menggunakan studi croos over)
18. Were appropriate statistical tests chosen to assess the data? Were the levels of
and error chosen before the data were gathered? Were multiple statistical
tests applied until a significant result was achieved?
Peneliti menggunakan SPSS versi 20 untuk analisis data, dan menggunakan
beberapa uji statistik untuk mendapatkan hasil seperti analisis univarian, t-
test, odd ratio, confidence interval)
19. Was patient compliance monitored? (Ya, Studi dan implikasi diperkenalkan
pada pasien dan mereka semua setuju untuk berpartisipasi.)
20. If multiple observers were collecting data, did the authors describe how
variations in measurements were avoided? (Peneliti menjelaskan variasi dengan
menggunakan analisis unvariated dengan regresi)
21. Did the authors justify the instrumentation used in the study? (Ya, )
22. Were measurements or assessments of effects made at the appropriate times
and frequency?
28. Are the conclusions supported by the data? Is some factor other than the study
treatment responsible for the outcomes? (Ya)
29. Are the results both statistically and clinically significant? (Ya, nilai dapat
dilihat pada p-value dari tabel)
31. Were appropriate references used? Are references timely and reputable? Have
any of the studies been disproven or updated? Do references cited represent a
complete background?