FormatLaporan Journal Reading

Judul Tulisan :

FLUVOXAMINE FOR THE TREATMENT OF ANXIETY DISORDERS IN CHILDREN AND ADOLESCENTS

Penulis : John T. Walkup, M.D., Michael J. Labellarte,M.D., and Mark A. Riddle, M.D., Johns Hopkins University; Daniel S. Pine, M.D., Laurence Greenhill, M.D., Rachel Klein, Ph.D., Mark Davies, M.P.H., and Michael Sweeney, Ph.D., Columbia University and New York State Psychiatric Institute; Howard Abikoff, Ph.D., Sabine Hack, M.D., and Brian Klee, M.D., New York University; James McCracken, M.D., Lindsey Bergman, Ph.D., and John Piacentini, Ph.D., University of California at Los Angeles; John March, M.D., M.P.H., and Scott Compton, Ph.D., Duke University; James Robinson, M.Ed., Thomas OHara, M.B.A., and Sherryl Baker, Ph.D., Nathan Kline Institute; and Benedetto Vitiello, M.D., Louise Ritz, M.B.A., and Margaret Roper, M.P.H Nama jurnal, volume, nomor dan tahun terbit :

FLUVOXAMINE FOR THE TREATMENT OF ANXIETY DISORDERS IN CHILDREN AND ADOLESCENTS N Engl J Med, Vol. 344, No. 17 April 26, 2001

Topik Judul dan abstrak

No 1

Keterangan 1. Indicate the studys material (ex plant) and subject (human or animal) 2. Provide in the abstract an informative and balanced summary of what was done and what was found 1. Menjelaskan subyek penelitian 2. Memberikan ringkasan yang informatif dan seimbang atas apa yang dilakukan dan apa yang 1.

Ditemukan di halaman berapa, jelaskan Subyek penelitian 128

dilakukan

terhadap

anak anak berusia antara 6 17 tahun dengan gejala kekhawatiran. (halaman1279, we studied 128 children who were 6 to 17 years age) 2.halaman 1279, Penjelasan mengenai metode yg

dilaksanakan di abstrak, the

ditemukan (hasil) dalam abstrak

childreen assigned

were to

randomly receive

fluvoxamine (at a maximum of 300 mg per day) Introduksi Latarbelakang 2 Explain the scientific background and rationale for the investigation being reported Menjelaskan latar belakang yang ilmiah dan rasional mengapa penelitian perlu dilakukan Halaman 1279, gangguan kecemasan adalah penyakit psikis yang paling sering diderita anak- anak, namun kebanyakan anak-anak tersebut tidak menerima pengobatan. banyak penelitian membahas masalah kegemukan pada anak anak tapi sangat sedikit penelitian tentang pengobatan untuk anak anak dengan penyakit gangguan kecemasan ini. (Anxiety disorders are the most common psychiatric

illness in childreen...) Tujuan 3 State specific objectives, including any prespecified hypotheses Menentukan tujuan spesifik, termasuk hipotesis yang diajukan. Hal. 1279 .Untuk mendapatkan data dari keselamatan dan kemanjuran dari serutonin reuptake inhibitors pada anak anak dengan gangguan kecemasan. (but limitede data are available on safety and efficacy of serotonin...) Bahan dan Cara

Bahan

Clearly defined how the material were collected and prepared Menjelaskan bagaimana data dikumpulkan dan disiapkan.

Awalnya ada 153 anak yang disiapkan serta dilakukan terapi psikoedukasi dan hasilnya ada 5 anak yang membaik dengan terapi tersebut, smentara ada 20 anak tidak hadir dalam terapi dan dinyatakan gagal ikut randomisasi, maka ada 128 anak yang ikut randomisasi Hal 1280 (We initially evaluated 153 children who presented, with their families, for treatment of anxiety at a participating center(We initially evaluated 153 children who presented, with their families, for treatment of anxiety at a participating center)

Participant Subyek penelitian

Eligibility criteria for participant / subject Kriteria subyek penelitian

Hal. 1279 -1280 Ada tiga kriteria subjek penelitian, 1) anak dengan gejala sindrom kecemasan harus melakukan pemeriksaan di klinik berdasarkan skala rata rata kecemasan anak anak 2)anak harus mendapatkan perawatan pelemahan berdasarkan skala global penaksiran anak anak (Childrens Global Assesment scale) 3) berdua antara anak dan

orang tua harus setuju untuk berkunjung ke klinik untuk pemeriksaan setiap minggunya. (First, the child had to have clinically important symptoms of anxiety according to the Pediatric Anxiethy rating Scale with this scale, the clinician assesses the childs degree of suffering and limitation in functioning associated with anxiety during the previous week. Second, the child had to have clinically important impairment according to the Childrens Global Assessment Scale (a score of less than 60) This scale assesses the degree to which psychiatric symptoms impede functioning. Third, both the child and a parent had to agree to attend the clinic weekly) Intervensi 6 Precise details of the intervention intended for each group and how and when they were actually administered Menjelaskan intervensi yang dilakukan pada tiap kelompok perlakuan dengan detail. Termasuk bagaimana dan kapan intervensi diberikan. pertama anak anak dan masing masing orang tua selama 3 minggu mendapatkan pendidikan terbuka mengenai psikologi.didapatkan 5 dari sampel mengalami kemajuan dengan cara pendidikan psikologi sehingga tidak memperlukan pengobatan medis, sisanya selama 8 minggu mendapatka pengobatan medis

menggunakan fluvoxamine atau placebo. Hal. 1280. (Paragraph 2, during this three week phase, we identified five childreen,,,,) Outcome 7 Clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements (e.g., multiple observations, training of assessors). Menjelaskan pengukuran outcome, baik utama maupun sekunder, Dua hasil pengukuran primer dimana perubahan skor nilai dalam rating skala Pediatric anxiety, yang ditinjau tiap minggunya, dan skor Clinical Global Impression-skala perkembangan pada akhir penelitan Hal.1280 (the two primary outcome measures were the change in the score on the pediatric anxiety rating scale...) Besar sampel 8 Subject number used in the study Jumlah subyek penelitian. Metode statistik 9 Statistical methods used to compare groups for primary outcome(s) and other outcome Metode statistik yang digunakan untuk membandingkan hasil kelompok satu dengan yang kelompok 128 children hal 1279 (We studied 128 children.) Efek dari tindakan pengobatan di analisis menggunakan analisis model campuran. Untuk Clinical Global Impressionimprovement scale digunakan metode analisis regresi logistik untuk keseluruhan 128 anak anak untuk mendapatkan taksiran efek dari perawatan selama 8 minggu.

Analisis dibentuk berdasarkan intensitas perawatan. Hal 1281. (...,we used Logistic regression analysis for all 128 children to asses the effect of treatment on the rattings at week 8,...) Hasil Alur penelitian 10 Defining the periods of study and follow-up Menjelaskan waktu penelitian dan follow-up 8 minggu hal 1279(the children were randomly assingned to receive fluvoxamine (at a maximum of 300mg per day) or placebo for eight weeks and were evaluated with rating scale designed to asses the degree of anxiety and impairment) Outcomedanestim asi 11 For each primary and secondary Hasil dengan terapi

outcome, a summary of results for fluvoxamine lebih efektif each group . Untuk tiap outcome utama dan sekunder, ringkasan atas hasil bagi tiap kelompok. disbanding placebo Hal 1282 (The children in the fluvoxamine group had greater reductions in symptoms of anxiety and higher rates of clinical response than the children in the placebo group )

Diskusi Interpretasi 12 Interpretation of the results, taking Bahaya yang ditimbulkan into account study hypotheses, sources of potential bias or dalam pengobatan menggunakan fluvoxamine

imprecision and the dangers associated with multiplicity of analyses and outcomes. Interpretasi hasil, memperhitungkan hipotesis penelitian, sumber bias atau ketidaktepatan dan bahaya yang berhubungan dengan keragaman analisis dan outcome. Generalizability 13 Generalizability (external validity) of the trial findings. Apakah hasil penelitian dapat digeneralisasikan di masyarakat.

adalah muculnya gejala gas troinstestinal.

Hal 1283 (,,,fluvoxamine was assocaited with significantly more gastrointestinak smptoms,...)

Sangat bisa diterapkan, kemanjuran pengobat menggunakan fluvoxamine dalam perawatan gangguan kecemasan pada anak anal dapat dibuktikan. Hal.1283 (Our report demonstrates the efficacy of fluvoxamine in the treatment of childreen with social phobia,separation anxiety disorder,or generalized anxiety disorders...)

Overall evidence

14

General interpretation of the results in the context of current evidence. Interpretasi umum terhadap hasil dalam konteks bukti terkini.

Penggunaan fluvoxamine hasilnya positif dan berguna kemanjurannya, ini sesuai dengan kalimat pada jurnal. Hal 1283 (Our report demonstrates the efficacy of fluvoxamine in the treatment of children with social phobia, separation anxiety disorder, or generalized anxiety disorder. Fluvoxamine treatment was generally well tolerated but was associated with significantly

more gastrointestinal symptoms, as found in other trials, and with greater increases in childrens levels of activity than was placebo. Effects on activity have been found in previous trials of selective serotonin-reuptake inhibitors in children, particularly in children younger than 13 years of age, but such effects typically have not been found in adults)