Worksheet Critical Appraisal Jurnal Terapi Citation:

Two-Day Regimen of Acyclovir for Treatment of Recurrent Genital Herpes Simplex Virus Type 2 Infection
Anna Wald, David Carrell, Michael Remington, Elizabeth Kexel, Judy Zeh, and Lawrence Corey Sumber : Clinical Infectious Diseases 2002;34:9448
Departments of Medicine, Epidemiology, Laboratory Medicine, and Statistics, University of Washington, and Program in Infectious Diseases, Fred Hutchinson Cancer Research Center, Seattle, Washington

Validitas 1a. Apakah alokasi pasien terhadap terapi / perlakuan dilakukan secara random?

Ya

Karena dalam penelitian menggunakan obat Acyclovir dan Plasebo untuk menilai hasil rata-rata dari kedua kekambuhan dapat digunakan sebagai unit analisis. The trial was randomized, double blind, and placebo controlled. Patients who met the entry criteria were randomized in a 1:1 ratio to receive either acyclovir (800 mg given by mouth [po] t.i.d.; the acyclovir group) or matching placebo (the placebo group) for 2 days. The same medication was dispensed for the first and second recurrence during the study. This study design was chosen so that the mean of the results from both recurrences could be used as a unit of analysis. This allowed us to recruit fewer patients than would have been required had each person been observed through only 1 recurrence.

1b. Apakah randomisasi dilakukan tersembunyi? 1c. Apakah antara subyek penelitian dan peneliti blind terhadap terapi / perlakuan yang akan diberikan? 2a. Apakah semua subjek yang ikut serta dalam penelitian diperhitungkan dalam hasil / kesimpulan? Apa follow-up pasien dilakukan cukup lengkap?

Tidak Tidak

Terdapat pada halaman 944 Tidak dijelaskan dalam penelitian ini Tidak dijelaskan dalam penelitian ini

Ya

Karena dari data hasil dengan total 131 orang diikutkan semua One hundred thirty-one persons (81 women and 50 men) were enrolled into the study. Of these 131 persons, 84 (51 women and 33 men) were observed for 1

recurrence, and 65 (40 women and 25 men) were observed for 2 recurrences. The median age of persons observed through a recurrence was 33.5 years (range, 2073 years), and 78 persons (93%) were white (table 1). None of the patients reported adverse events, including allergic reactions. 2b. Apakah pengamatan yang dilakukan cukup panjang? Tidak Terdapat pada result halaman 945 Karena hanya dilakukan selama 2 hari The standard course of antiviral therapy for recurrent genital herpes requires administration of multiple doses of medication for 5 days. To assess the efficacy of a shorter course of antiviral therapy, patients with recurrent genital herpes simplex virus type 2 (HSV-2) infection were enrolled in a randomized, double-blind, placebo controlled study of acyclovir (800 mg given by mouth 3 times per day [t.i.d.]) for 2 days. 2c. Apakah subjek dianalisis pada kelompok dimana subjek tersebut dikelompokkan dalam randomisasi? 3a. Selain perlakuan yang dieksperimenkan, apakah subjek diperlakukan sama? Tidak Terdapat pada halaman 944 Tidak dijelaskan dalam penelitian ini

Ya

Karena pasien semua diperlakukan sama sesuai anjuran peneliti For each episode, each participant was given 3 doses of study medication and a diary card. Subjects were asked to start use of the study medication as soon as possible, but not more than 12 h after the first signs or symptoms of a genital herpes re- currence, and to return to the clinic within 24 h. At that time, herpes recurrence was confirmed by means of a clinical ex- amination and viral culture, and the remaining 3 doses of med- ication were dispensed. Patients returned to the clinic for subsequent evaluations on days 2, 3, 5, and 7 after starting treatment, and then every other day thereafter until the lesions healed. Terdapat pada halaman 945

3b. Apakah kelompok dalam penelitian sama pada awal penelitian?

Ya

Kelompok dalam penelitian sama pada awal penelitian. One hundred thirty-one persons (81 women and 50 men) were enrolled into the study. Of these 131 persons, 84 (51 women and 33 men) were observed for 1

recurrence, and 65 (40 women and 25 men) were observed for 2 recurrences. The median age of persons observed through a recurrence was 33.5 years (range, 2073 years), and 78 persons (93%) were white (table 1). None of the patients reported adverse events, including allergic reactions. Terdapat pada result halaman 945

Applicable 1. Apakah pasien yang kita miliki sangat berbeda dengan pasien dalam penelitian ? 2. Apakah hasil yang baik dari penelitian dapat diterapkan dengan kondisi yang kita miliki ?

Ya

Pasien yang kita miliki berbeda dengan pasien yang ada di jurnal. Dilihat dari segi sosiobudaya dan angka pravelensinya lebih tinggi ketimbang di Indonesia

Ya

Dapat diterapkan, karena terbukti dari penelitian efektif untuk mengobati herpes simplex dan obat Acyclovir di jual indonesia Tidak dijelaskan dalam penelitian ini tentang efek samping obat yang diberikan

3. Apakah semua outcome klinis Tidak yang penting dipertimbangkan yang mungkin

(efek samping timbul)?

4. Apakah sudah memahami harapan dan pilihan pasien ?

Ya

Karena terbukti efektif untuk menyembuhkan penyakit Herpes Simplex yang berulang selama pemberian 2 hari