Critical Appraisal on Therapy
“Effect of Antenatal Corticosteroid and Antibiotics in Pregnancies Complicated by Premature Rupture of Membranes between 24 and 28 weeks of Gestation”
Clinical Question
l Components of foreground question (PICO):
¡ Patient and the problem: ketuban pecah dini kehamilan preterm 24 sampai 28 minggu dan luaran bayi
¡ Intervention: kortikosteroid dan antibiotika
¡ Comparison: tanpa terapi
¡ Outcome of interest: apgar skor dan respiratory distress syndrom
Pertanyaan:
Apakah kortikosteroid dan antibiotika memberikan luaran bayi yang lebih baik pada pasien dengan ketuban pecah dini kehamilan preterm 24 sampai 28 minggu?
Searching strategy
Dengan keyword: ketuban pecah dini, hamil preterm, antibiotika dan kortikosteroid maka didapatkan jurnal ini yaitu:
“Effect of Antenatal Corticosteroid and Antibiotics in Pregnancies Complicated by Premature Rupture of Membranes between 24 and 28 weeks of Gestation”
Downloaded from: J Korean Med Sci 2005
Critical Appraisal on Therapy
I. Are the results of this single preventive or therapeutic trial valid?
1. Was the assignment of patients to treatments randomised ? and was the randomisation list concealed?
Tidak. Karena subyek
Ya. Skema randomisasi menggunakan program komputer dan disembunyikan dari peneliti, klinisi dan pasien.
2. Were all patient who entered the trial accounted for its conclusion? –and were they analysed in the groups to which they were randomised?
Ya. Dari 50 subyek yang ikut penelitian, 10 dieksklusi karena tidak tepatnya inklusinya (40 pasien dianalisis)
Ya. Subyek dianalisa berdasar kelompoknya masing-masing.
3. Were patients and clinicians kept “blind” to which treatment was being received?
Ya. Jenis obat yang diberikan tidak diketahui oleh peneliti, klinisi, dan pasien.
4. Aside from the experimental treatment, were the groups treated equally?
Ya. Karena semua kelompok mendapat perlakuan yang sama di luar obat yang diteliti
5.Were the groups similar at the start of trial?
Ya.
Aspirin
Plasebo
SGA +
1
4
SGA -
15
13
Occurrence of clinical resolution
Relative Risk Reduction (RRR)
Absolute Risk Reduction (ARR)
Number Needed
To Treat (NNT)
Usual SGA on plasebo Control
Event Rate
CER
Aspirin Experimental Event Rate
EER
CER-EER
CER
CER-EER
1/ARR
23%
7%
(23%-7%) 23%
= 69%
(23%-7%)
= 16%
1 / 16% =
6
3. Can you apply this valid, important evidence about a treatment in caring for your patient?
Is our patient so different from those in the trial that its result can’t help you?
Tidak. Penelitian ini bisa diaplikasikan
How great would the potential benefit of therapy actually be for your individual patient?
Aspirin tidak memberikan pengaruh yang bermakna pada antenatal ataupun outcome neonatal.
Kesimpulan apraisal jurnal ini
l tidak valid
l important
l
…important aplicable
Sehingga jawaban dari pertanyaan klinis yang diajukan sebelumnya adalah, aspirin tidak mempengaruhi outcome kehamilan pada wanita hamil dengan sindroma antiphospholipid.
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