Critical Appraisal of Observational Study in Epidemiology dr. YUDHI WIBOWO, M.PH
OUTLINE • PENDAHULUAN • SIKLUS EBM & KOMPONEN TELAAH jURNAL • MEMAHAMI LAPORAN JURNAL OBSERVATIONAL STUDY in EPIDEMIOLOGY STROBE • CA JURNAL OBSERVATIONAL STUDY IN EPIDEMIOLOGY • KESIMPULAN
PENDAHULUAN
Bailey et al. (2005) Introduction to Epidemiology. London:McGraw-Hill
PENDAHULUAN • Much biomedical research (9 of 10) is observational. • The reporting of such research is often inadequate, • Which hampers the assessment of its strengths and weaknesses and of a study’s generalizability. • However, in published observational research important information is often missing or unclear. (Erik et al., 2007)
• An analysis of epidemiological studies published in general medical and specialist journals found that the rationale behind the choice of potential confounding variables was often not reported (Pockok et al., 2004). • Only few reports of case-control studies in psychiatry explained the methods used to identify cases and controls (Lee et al., 2007). • In a survey of longitudinal studies in stroke research, 17 of 49 articles (35%) did not specify the eligibility criteria (Tooth et al., 2005).
SIKLUS EBM Menemukan Kasus
Menjawab Pertanyaan
Telaah Jurnal
Mengembangkan Pertanyaan
Mencari Rujukan
MEMAHAMI LAPORAN JURNAL OBSERVATIONAL STUDY in EPIDEMIOLOGY STROBE
• The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). • What should be included in an accurate and complete report of an observational study. • Covered three main study designs: cohort, case-control and cross-sectional studies
• A checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results and discussion sections of articles. • Eighteen items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. • To improve the quality of reporting of observational studies
Introduction 1. Background/rationale: •
• •
besar masalah: prevalensi/insidensi/jumlah, dibandingkan dengan sebelumnya, di tempat lain, target program & dampak Elaborasi: substansi & metodologis Kesenjangan: substansi, metodologis, konfirmasi penelitian sebelumnya
2. Tujuan Utama penelitian (primary outcome): paling diminati peneliti, desain dirancang utk menjawab pertanyaan, sbg dasar perhitungan besar sampel
KOMPONEN TELAAH JURNAL (VIA) V Interna non-kausal V V Interna kausal
V Eksternal
•V Seleksi •V informaasi •V perancu •V analisis
•Temporality •Degree of association •Dose response •Consistency •Coherency •Specivicity •Biological plausibility
• V eksterna 1 • V eksterna 2
Kepeentingan hasil penelitian secara klinis
I
•Transportability •Kodisi pasien •Kemampuan pelayanan •Ekonomi •Sosial budaya •Agama
A
CA OBSERVATIONAL STUDY IN EPIDEMIOLOGY
1. DESKRIPSI UMUM • Desain • Populasi target, populasi terjangkau, sampel • Teknik sampling • Variabel bebas, tergantung • Hasil utama (primary outcome)
2. Validitas interna, hubungan non-kausal • Pengaruh bias • Pengaruh perancu • Pengaruh peluang
3. Validitas interna, hubungan kausal • • • • • • •
Temporabilitas Asosiasi kuat Dosis respon Konsistensi Spesifik Koherensi Biologically plausible
4. Validitas eksterna • • •
Apakah hasil dapat diterapkan pada subyek terpilih Apakah hasil dapat diterapkan pada populasi terjangkau Apakah hasil dapat diterapkan pada populasi luas
Kriteria Kausasi
Machin, D. & Campbell, M.J. (2005) The Design of Studies for Medical Research. England: John Wiley & Sons Ltd.
CA MASIH DIPERLUKAN KOMPONEN: 1. IMPORTANCY : kepentingan hasil penelitian secara klinis (effect size) 2. APPLICABILITY : transportability, kondisi pasien, kemampuan pelayanan, ekonomi, sosial budaya, agama.
Kesimpulan • Dokter harus mampu melakukan telaah jurnal dengan baik. • Observational Study in Epidemiology STROBE • CA ada 3 komponen (VIA): – Validitasvaliditas interna non-kausal, validitas interna kausal (eksternaBradfold-Hill criteria), validitas. – Importancy – Applicability
Reference • Erik von Elm,a Douglas G Altman,b Matthias Egger,a,c Stuart J Pocock,d Peter C Gøtzsche e & Jan P Vandenbrouckef for the STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Bulletin of the World Health Organization 2007;85:867–872. • Pocock SJ, Collier TJ, Dandreo KJ, de Stavola BL, Goldman MB, Kalish LA, et al. Issues in the reporting of epidemiological studies: a survey of recent practice. BMJ 2004;329:883 • Lee W, Bindman J, Ford T, Glozier N, Moran P, Stewart R, et al. Bias in psychiatric case-control studies: literature survey. Br J Psychiatry 2007;190:204-9. • Tooth L, Ware R, Bain C, Purdie DM, Dobson A. Quality of reporting of observational longitudinal research. Am J Epidemiol 2005;161:280-8. • Bonita, R., Beaglehole, R. & Kjellstrom, T. (2006) Basic pidemiology Ed.2.WHO.
• Dahlan, M.S. (2010) Membaca dan menelaah jurnal uji klinis. Jakarta:Salemba Medika. • Sastroasmoro, S. & Ismael, S. (2010) Dasardasar Meodologi Penelitian Klinis Ed.3.Jakarta:Sagung Seto. • Machin, D. & Campbell, M.J. (2005) The Design of Studies for Medical Research. England: John Wiley & Sons Ltd
