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Öz

The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for Reporting Observational Studies Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in email discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, , introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available on the Web sites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies.

Anahtar Kelimeler

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STROBE BİLDİRİMİ: EPİDEMİYOLOJİDE GÖZLEMSEL ARAŞTIRMA RAPORU YAZIMININ GÜÇLENDİRİLMESİ İÇİN BİR REHBER

Öz

Biyomedikal araştırmaların çoğu gözlemsel niteliktedir. Bu tür araştırma raporlarının yazımı sıklıkla yetersizdir. Bu durum gözlemsel araştırmaların güçlü ve zayıf yönlerinin ve genellenebilirliğinin değerlendirilmesini zorlaştırmaktadır. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) girişimi, tam ve doğru bir gözlemsel araştırma raporunun neleri içermesi gerektiği konusunda öneriler geliştirmiştir. Bu önerilerin kapsamı kohort, vaka-kontrol ve kesitsel çalışmalar olmak üzere üç ana çalışma tasarımını kapsayacak şekilde tanımlanmıştır. Eylül 2004’te, taslak kontrol listesinin maddelerini oluşturmak için araştırmacı, metodolog ve dergi editörlerinden oluşan iki günlük bir workshop yapılmıştır. Bu liste, deneysel kanıtları ve metodolojik varsayımları dikkate alan geniş bir STROBE katılımcı grubu ile birlikte e-mail tartışmasında ve koordinasyon grubunun yaptığı bir dizi toplantıda revize edilmiştir. Workshop ve arka arkaya tekrarlayan danışma ve revizyon süreci sonucunda makalenin başlık, özet, giriş, metot, bulgular ve tartışma bölümleri ile ilgili 22 maddeden oluşan bir kontrol listesi (STROBE Bildirimi) hazırlanmıştır. 18 madde her üç araştırma desenine de genel ve dört madde ise kohort, vaka-kontrol ve kesitsel çalışmalara özeldir. Ayrıca, buna ek olarak ayrıntılı bir Açıklama ve İşleme dokümanı yayınlanmıştır ve bu yayına PLoS Medicine, Annals of Internal Medicine ve Epidemiology’nin Web sitesinden ücretsiz olarak erişilebilir. STROBE Bildirimi’nin gözlemsel araştırma raporlarının yazım kalitesinin geliştirilmesine katkı sağlaması ümit edilmektedir.

Kaynakça

1. Anonymous. Guidelines for Documentation of Epidemiologic Studies. Epidemiology Work Group of the Interagency Regulatory Liaison Group. Am J Epidemiol 1981; 114(5): 609–13.
2. Bartlett C, Sterne J, Egger M. What is Newsworthy? Longitudinal Study of the Reporting of Medical Research in two British Newspapers. BMJ 2002; 325(7355): 81–4.
3. Black N. Why We Need Observational Studies to Evaluate The Effectiveness of Health Care. BMJ 1996; 312(7040): 1215–8.
4. Bogardus ST Jr, Concato J, Feinstein AR. Clinical Epidemiological Quality in Molecular Genetic Research: The Need For Methodological Standards. JAMA 1999; 281(20): 1919–26.
5. Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, et al. Towards Complete and Accurate Reporting of Studies of Diagnostic Accuracy: The STARD Initiative. Ann Intern Med 2003; 138(1): 40–4.
6. Campbell MK, Elbourne DR, Altman DG; CONSORT Group. CONSORT Statement: Extension to Cluster Randomised Trials. BMJ 2004; 328(7441): 702–8.
7. Egger M, Jüni P, Bartlett C. Value of Flow Diagrams in Reports of Randomized Controlled Trials. JAMA 2001; 285(15): 1996–9.
8. Egger M, Schneider M, Davey Smith G. Spurious Precision? Metaanalysis of Observational Studies. BMJ 1998; 316(7125): 140–4.

9. Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C; CONSORT Group. Reporting Randomized, Controlled Trials of Herbal Interventions: An Elaborated CONSORT Statement. Ann Intern Med 2006; 144(5): 364–7.
10. Glasziou P, Vandenbroucke JP, Chalmers I. Assessing the Quality of Research. BMJ 2004; 328(7430): 39–41.
11. Ioannidis JP, Evans SJ, Gİtzsche PC, O’Neill RT, Altman DG, Schulz K, Moher D; CONSORT Group. Better Reporting of Harms in Randomized Trials: An Extension of The CONSORT Statement. Ann Intern Med 2004; 141(10): 781–8.
12. Ioannidis JP, Gwinn M, Little J, Higgins JP, Bernstein JL, Boffetta P, et al. A Road Map for Efficient and Reliable Human Genome Epidemiology. Nat Genet 2006; 38(1): 3–5.
13. Jüni P, Altman DG, Egger M. Systematic Reviews in Health Care: Assessing the Quality of Controlled Clinical Trials. BMJ 2001; 323(7343): 42–6.
14. Lee W, Bindman J, Ford T, Glozier N, Moran P, Stewart R, Hotopf M. Bias in Psychiatric CaseControl Studies: Literature Survey. Br J Psychiatry 2007; 190(3): 204–9.
15. Moher D, Altman DG, Schulz KF, Elbourne DR. Opportunities and Challenges for Iimproving the Quality of Reporting Clinical Research: CONSORT and Beyond. CMAJ 2004; 171(4): 349–50.
16. Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF. Improving the Quality of Reports of Meta-Analyses of Randomised Controlled Trials: The QUOROM Statement. Quality of Reporting of MetaAnalyses. Lancet 1999; 354(9193): 1896–900.
17. Moher D, Schulz KF, Altman DG. The CONSORT Statement: Revised Recommendations for Improving The Quality of Reports of Parallel-Group Randomised Trials. Lancet 2001; 357(9263): 1191–4.
18. Ormerod AD CONSORT Your Submissions: An Update for Authors. Br J Dermatol 2001; 145(3): 378–
19. Papanikolaou PN, Christidi GD, Ioannidis JP. Comparison of Evidence on Harms of Medical Iinterventions in Randomized and Nonrandomized Studies. CMAJ 2006; 174(5): 635–41.
20. Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ. Reporting of Noninferiority and Equivalence Randomized Trials: An Extension of The CONSORT Statement. JAMA 2006; 295(10): 1152–
21. Plint AC, Moher D, Morrison A, Schulz K, Altman DG, Hill C, Gaboury I. Does the CONSORT Checklist Improve The Quality of Reports of Randomised Controlled Trials? A Systematic Review. Med J Aust 2006; 185(5): 263–7.
22. 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(7471): 883.
23. Rennie D. CONSORT Revised—Improving the Reporting of Randomized Trials. JAMA 2001; 285(15): 2006–7.
24. Sanderson S, Tatt ID, Higgins JP. Tools For Assessing Quality and Susceptibility to Bias in Observational Studies in Epidemiology: A Systematic Review and Annotated Bibliography. Int J Epidemiol 2007; 36(3): 666–76.
25. Schriger DL. Suggestions for Improving The Reporting of Clinical Research: The Role of Narrative. Ann Emerg Med 2005; 45(4): 437–43.
26. Tooth L, Ware R, Bain C, Purdie DM, Dobson A. Quality Of Reporting Of Observational Longitudinal Research. Am J Epidemiol 2005; 161(3): 280–8.
27. Vandenbroucke JP, von Elm E, Altman DG, Gİtzsche PC, Mulrow CD, Pocock SJ, et al. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration. PLoS Med 2007a; 16(4): e297.
28. Vandenbroucke JP, von Elm E, Altman DG, Gİtzsche PC, Mulrow CD, Pocock SJ, et al. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration. Ann Intern Med 2007b; 147(8): 163-94.
29. Vandenbroucke JP, von Elm E, Altman DG, Gİtzsche PC, Mulrow CD, Pocock SJ, et al. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration. Epidemiology 2007c; 18(6): 805-35.