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RIZKA METYA 1102010250 Evidence Based Medicine KASUS Diare berada diperingkat ke-dua pada penyakit yang sering

dialami anak-anak. Maka dilakukan uji acak terkontrol atau disebut RCT (Randomized Controlled Trial) yang digunakan pada uji coba obat atau prosedur medis Dari uji yang didapat; Diidentifikasi138 RCT melaporkan 1 atau lebih hasil yang berhubungan dengan diare akut anak / penyakit. Termasuk percobaan digunakan 64 definisi yang unik dari diare, 69 definisi unik resolusi diare, dan 46 hasil utama yang unik. Mayoritas percobaan dievaluasi termasuk aktivitas penyakit klinis jangka pendek (insiden dan durasi diare), hasil laboratorium, atau gabungan dari titik akhir. 32 percobaan menggunakan instrumen (misalnya, tunggal dan multidomain sistem penilaian) untuk mendukung penilaian aktivitas penyakit. Dari jumlah tersebut, 3 percobaan menyatakan bahwa instrumen ini berlaku, namun, tidak ada catatan resmi melaporkan bukti validitas ini. Secara keseluruhan kualitas percobaan metodologis termasuk baik. Tetapi baik uji klinis, metodologis suara, definisi diare, hasil utama, dan instrumen yang digunakan dalam RCT diare akut pada anak menunjukkan hasil yang berbeda-beda. Kurangnya bukti validitas dan focus pada indeks yang mungkin tidak diperlukan bagi partisipan .

PICO Problem: Diare berada diperingkat ke-dua pada penyakit yang sering dialami anak-anak. Intervention: melakukan uji terkontrol atau RCT pada anak-anak penderita diare akut. Comparison: Mencari CENTRAL, Embase, Kesehatan Global, dan Medline dari awal kasus terjadi hingga Februari 2009. Dari jumlah keseluruhan, 3 percobaan menyatakan bahwa instrumen ini berlaku, namun, tidak ada catatan resmi melaporkan bukti validitas ini. Secara keseluruhan kualitas percobaan metodologis termasuk baik. Outcome: baik uji klinis, metodologis suara, definisi diare, hasil utama, dan instrumen yang digunakan dalam RCT diare akut pada anak menunjukkan hasil yang berbeda-beda. Kurangnya bukti validitas dan focus pada indeks yang mungkin tidak diperlukan bagi

partisipan .

Kata kunci: Pediatric Diarrhea Pemilihan situs: http://pediatrics.aappublications.org/ Hasil pencarian: 12 data Artikel yang dipilih: Measurement Issues in Trials of Pediatric Acute Diarrheal Diseases: A Systematic Review

Measurement Issues in Trials of Pediatric Acute Diarrheal Diseases: A Systematic Review


Abstract
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AUTHORS: Bradley C. Johnston, PhD,a Larissa Shamseer, MSc,b Bruno R. da Costa, MSc,c Ross T. Tsuyuki, PharmD, MSc,d,e and Sunita Vohra, MD, MScb,e
Department of Clinical Epidemiology and Biostatistics, McMaster University, Health Sciences Centre, Hamilton, Ontario, Canada; bCARE Program, Department of Pediatrics, and dEPICORE Centre, Department of Medicine, Edmonton General Hospital, University of Alberta, Edmonton, Alberta, Canada; cInstitute of Social and Preventive Medicine, University of Bern, Bern, Switzerland; and eSchool of Public Health, University of Alberta, Edmonton, Alberta, Canada KEY WORDS randomized trials, pediatrics, acute diarrhea, definitions, outcomes ABBREVIATIONS PADpediatric acute diarrhea RCTrandomized, controlled trial CENTRALCochrane Central Register of Controlled Trials WHOWorld Health Organization Dr Johnston participated in screening, data extraction, and quality assessment of articles, completed the analysis, interpreted the results, and drafted the manuscript; Ms Shamseer participated in screening, data extraction, and quality assessment; Mr daCosta participated in screening articles for eligibility and data analysis; Drs Tsuyuki and Vohra participated in the design of study and interpretation of the results; and all authors critically revised the article and approved the version to be published. www.pediatrics.org/cgi/doi/10.1542/peds.2009-3667 doi:10.1542/peds.2009-3667 Accepted for publication Mar 9, 2010 Address correspondence to Bradley C. Johnston, PhD, Department of Clinical Epidemiology and Biostatistics, McMaster University, Health Sciences Centre 2C12, 1200 Main St W, Hamilton, Ontario, Canada L8N 3Z5. E-mail: bjohnst@mcmaster. caAccepted for publication Mar 9, 2010 PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275). Copyright 2010 by the American Academy of Pediatrics FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.
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BACKGROUND: Worldwide, diarrheal diseases rank second among conditions that afflict children. Despite the disease burden, there is limited consensus on how to define and measure pediatric acute diar- rhea in trials. OBJECTIVES: In RCTs of children involving acute diarrhea as the pri- mary outcome, we documented (1) how acute diarrhea and its resolu- tion were defined, (2) all primary outcomes, (3) the psychometric prop- erties of instruments used to measure acute diarrhea and (4) the methodologic quality of included trials, as reported. METHODS: We searched CENTRAL, Embase, Global Health, and Medline from inception to February 2009. English-language RCTs of children younger than 19 years that measured acute diarrhea as a primary outcome were chosen. RESULTS: We identified 138 RCTs reporting on 1 or more primary out- comes related to pediatric acute diarrhea/diseases. Included trials used 64 unique definitions of diarrhea, 69 unique definitions of diar- rhea resolution, and 46 unique primary outcomes. The

majority of included trials evaluated short-term clinical disease activity (incidence and duration of diarrhea), laboratory outcomes, or a composite of these end points. Thirty-two trials used instruments (eg, single and multidomain scoring systems) to support assessment of disease ac- tivity. Of these, 3 trials stated that their instrument was valid; however, none of the trials (or their citations) reported evidence of this validity. The overall methodologic quality of included trials was good. CONCLUSIONS: Even in what would be considered methodologically sound clinical trials, definitions of diarrhea, primary outcomes, and instruments employed in RCTs of pediatric acute diarrhea are hetero- geneous, lack evidence of validity, and focus on indices that may not be important to participants. Pediatrics 2010;126:e222e231