News_GoodClinical_egger_gcp.ppt

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News_GoodClinical_egger_gcp.ppt

  1. 1. STROBE Strengthening the Reporting of Observational Studies in Epidemiology …und andere Reporting guidelines Matthias Egger Institut für Sozial- und Präventivmedizin Universität Bern www.ispm.ch
  2. 2. Menu <ul><li>Warum brauchen wir „reporting guidelines“? </li></ul><ul><li>Lehren aus CONSORT </li></ul><ul><li>Beobachtende Studien </li></ul><ul><li>Die STROBE Initiative </li></ul>
  3. 3. Transparenz im Publizieren von Forschungresultaten <ul><li>Wissenschaftliche Artikel sollten so geschrieben werden, dass der Leser die Qualität der Studie und die Bedeutung der Resultate wirklich evaluieren kann </li></ul><ul><li>Die Beurteilung der Qualität publizierter Studien ist oft schwierig weil wichtige Aspekte fehlen oder unklar bleiben. </li></ul><ul><li>Autoren und Journals haben eine Verpflichtung dafür zu sorgen, dass Studien transparent und vollständing berichtet werden. </li></ul>
  4. 4. Lancet 1996
  5. 5. <ul><li>“The patients were randomly assigned to receive either ...[treatment] ... or a similar number of placebo pills for three weeks. ... </li></ul><ul><li>The patients served as their own controls: in the next three weeks ... they received the other agent.“ </li></ul>Ein Beispiel: publiziert
  6. 6. <ul><li>“ One part-time research assistant was assigned the task of randomly picking whether the patient was to have active treatment then placebo; or vice versa. </li></ul><ul><li>She was responsible for packaging and delivering the medications in sequence of her choice to the patients and kept her records at home. </li></ul><ul><li>This was a crude method ... it worked for us.“ </li></ul>Was wirklich geschah
  7. 7. Unterlaufen der Randomisierung: Beispiel Briefumschläge <ul><li>Lichtundurchlässig </li></ul><ul><li>Verschlossen </li></ul><ul><li>Fortlaufend nummeriert </li></ul><ul><li>Log Buch </li></ul>Schulz Lancet 1995
  8. 9. CONSORT Consolidated Standards of Reporting Trials www.consort-statement.org
  9. 10. CONSORT flow chart
  10. 11. <ul><li>Academic Emergency Medicine </li></ul><ul><li>Acta Neurologica Scandinavia </li></ul><ul><li>Advances in Neonatal Care </li></ul><ul><li>African Journal of Medicine </li></ul><ul><li>AIDS </li></ul><ul><li>Alcohol and Alcoholism </li></ul><ul><li>Alternative Therapies in Health and Medicine </li></ul><ul><li>American Journal of Occupational Therapy </li></ul><ul><li>Amyotrophic Lateral Sclerosis and Other Motor Neuron Disorders </li></ul><ul><li>Anesthesiology </li></ul><ul><li>Annals of Behavioral Medicine </li></ul><ul><li>Annals of Clinical Microbiology and Antimicrobials </li></ul><ul><li>Annals of Emergency Medicine </li></ul><ul><li>Annals of Family Medicine </li></ul><ul><li>Annals of General Hospital Psychiatry </li></ul><ul><li>Annals of Internal Medicine </li></ul><ul><li>Annals of Neurology </li></ul><ul><li>Annals of Oncology </li></ul><ul><li>Annals of Rheumatic Diseases </li></ul><ul><li>Archives of Dermatology </li></ul><ul><li>Archives of Disease in Childhood </li></ul><ul><li>Archives of Family Medicine </li></ul><ul><li>Archives of General Psychiatry </li></ul><ul><li>Archives of Internal Medicine </li></ul><ul><li>Archives of Neurology </li></ul><ul><li>Archives of Ophthalmology </li></ul><ul><li>Archives of Otolaryngology </li></ul><ul><li>Archives of Pathology and Laboratory Medicine </li></ul><ul><li>Archives of Pediatrics & Adolescent Medicine </li></ul><ul><li>Archivesof Surgery </li></ul><ul><li>Armenian Medical Review Journal </li></ul><ul><li>Arthritis Research & Therapy </li></ul><ul><li>Atencion Primaria </li></ul><ul><li>Australian and New Zealand Journal of Surgery </li></ul><ul><li>BandolierBioMagnetic Research and Technology </li></ul><ul><li>Brazilian Journal of Cardiovascular Surgery< </li></ul><ul><li>British Dental Journal </li></ul><ul><li>British Journal of Dermatology </li></ul><ul><li>British Journal of Obstetrics & Gynaecology </li></ul><ul><li>British Journal of Ophthalmology </li></ul><ul><li>British Journal of Surgery </li></ul><ul><li>BMJ </li></ul><ul><li>Canadian Journal of Anesthesia </li></ul><ul><li>Canadian Journal of Emergency Medicine </li></ul><ul><li>Canadian Journal of Infectious Diseases </li></ul><ul><li>Canadian Journal of Neurological Sciences </li></ul><ul><li>Canadian Journal of Occupational Therapy </li></ul><ul><li>Canadian Journal of Respiratory Therapy </li></ul><ul><li>Canadian Medical Association Journal </li></ul><ul><li>Cancer </li></ul><ul><li>Cardiovascular Diabetology </li></ul><ul><li>Cardiovascular Ultrasound </li></ul><ul><li>Chinese Medical Journal </li></ul><ul><li>Climacteric </li></ul><ul><li>Clinical and Molecular Allergy </li></ul><ul><li>Clinical Chemistry </li></ul><ul><li>Clinical Oral Investigations </li></ul><ul><li>Comparative Hepatology </li></ul><ul><li>Cost Effectiveness and Resource Allocation </li></ul><ul><li>Croatian Medical Journal </li></ul><ul><li>Journal of the American College of Surgeons </li></ul><ul><li>Journal of the American Geriatrics Society </li></ul><ul><li>Journal of the American Medical Association </li></ul><ul><li>Journal of the American Podiatric Medical Association </li></ul><ul><li>Journal of the American Society of Nephrology </li></ul><ul><li>Journal of the Canadian Chiropractic Association </li></ul><ul><li>Journal of the Canadian Dental Association </li></ul><ul><li>Journal of the National Cancer Institute </li></ul><ul><li>Journal of the Society of Laparoendoscopic Surgeons </li></ul><ul><li>Kinetoplastid Biology and Disease </li></ul><ul><li>Kuwait Medical Journal </li></ul><ul><li>Lancet (The) </li></ul><ul><li>Lancet Oncology (The) </li></ul><ul><li>Malawi Medical Journal </li></ul><ul><li>Mayo Clinic Proceedings </li></ul><ul><li>Medical Acupuncture </li></ul><ul><li>Medical Immunology </li></ul><ul><li>Medical Journal of Australia </li></ul><ul><li>Molecular Pathology </li></ul><ul><li>Movement Disorders </li></ul><ul><li>National Medical Journal of India </li></ul><ul><li>Nederlands Tijdschrift voor Geneeskunde </li></ul><ul><li>Neurology </li></ul><ul><li>Neurology India </li></ul><ul><li>Neuropsychology </li></ul><ul><li>New England Journal of Medicine </li></ul><ul><li>New Zealand Journal of Medical Laboratory Science </li></ul><ul><li>Nutrition Journal </li></ul><ul><li>Obstetrics and Gynecology </li></ul><ul><li>Onkologie </li></ul><ul><li>Ophthalmic and Physilogical Optics </li></ul><ul><li>Ophthalmology </li></ul><ul><li>Palliative Medicine </li></ul><ul><li>Pediatric Pulmonology </li></ul><ul><li>Pediatrics </li></ul><ul><li>Physical Therapy Review </li></ul><ul><li>Phytomedicine </li></ul><ul><li>PLoS Medicine </li></ul><ul><li>Psychosomatic Medicine </li></ul><ul><li>Radiotherapy & Oncology </li></ul><ul><li>Reproductive Biology and Endocrinology </li></ul><ul><li>Resuscitation </li></ul><ul><li>Revista Brasileira de Cirurgia Cardiovascular </li></ul><ul><li>Revista Espanola de Alergol Immunol Clinica </li></ul><ul><li>Revista Espanola de Salud Publica </li></ul><ul><li>Revista Sanidad Militar de Mexico </li></ul><ul><li>Rheumatology </li></ul><ul><li>Rinsho Hyoka (Clinical Evaluation) </li></ul><ul><li>Sau Paulo Medical Journal </li></ul><ul><li>Scandinavian Journal of Gastroenterology </li></ul><ul><li>Der Schmerz </li></ul><ul><li>Sexually Transmitted Infections </li></ul><ul><li>Spine </li></ul><ul><li>Thrombosis Journal </li></ul><ul><li>Ugeskrift for Laeger </li></ul><ul><li>Veterinary Journal (The) </li></ul><ul><li>World Journal of Surgical Oncology </li></ul><ul><li>Zeitschrift für ärztliche Fortbildung und Qualitätssicherung </li></ul>Current Controlled Trials in Cardiovascular Medicine Diabetes Care Diseases of the Colon & Rectum Dynamic Medicine East African Medical JournaleHealth International Equine Veterinary Journal European Journal of Anaesthesiology European Journal of Cancer European Journal of Oral Sciences European Journal of Vascular and Endovascular Surgery Environmental Health: A Global Access Science Source Eye Foot (The) Gastroenterology Gujarat Medical Journal Gut Health Psychology Heart Hepatobiliary & Pancreatic Diseases International Huisarts & Wetenschap Human Reproduction Indian Journal of Dermatology Indian Journal of Pharmacology Indian Pediatrics Intensive Care Medicine International Endondontic Journal International Journal of Clinical Oncology International Journal of Endodontics International Journal of Surgery International Journal of Phytotherapy and Phytopharmacology International Urogynecology Journal and Pelvic Floor Dysfunction Japanese Journal of Clinical Oncology Journal of Alternative & Complementary Medicine Journal of Bone & Joint Surgery Journal of Clinical Pathology Journal of Endodontics Journal of Experimental & Clinical Cancer Research Joural of Family Planning & Reproductive Health Care Journal of General Internal Medicine Journal of Geriactric Care Journal of Health Services Research and Policy Journal of Hepatology Journal of Immune Based Therapies and Vaccines Journal of Manipulative & Physiological Therapeutics Journal of Medical Internet Research Journal of Neurological Science (Turkey) Journal of Neurology, Neurosurgery & Psychiatry Journal of Nuclear Medicine Journal of Nutrition Journal of Orthodontics Journal of Pediatric Orthopaedics Journal of Pediatrics Journal of Postgraduate Medicine Journal of Rural & Remote Health Journal of the American Academy of Child & Adolescent Psychiatry
  11. 12. Faktoren für den Erfolg von CONSORT <ul><li>Kollaborativer, offener Prozess </li></ul><ul><li>Breite Beteiligung in der Gruppe </li></ul><ul><ul><li>Methodologen </li></ul></ul><ul><ul><li>Klinische Forscher </li></ul></ul><ul><ul><li>Editors </li></ul></ul><ul><li>Fokus auf Berichterstattung, nicht Durchführung </li></ul><ul><li>‘ Evidence-based’ </li></ul><ul><li>Evaluationen </li></ul><ul><li>Publikationen in bekannten Journals </li></ul>
  12. 13. Beobachtende Studien <ul><li>Wichtig zur Erfassung unerwünschter Wirkungen </li></ul><ul><li>Fast alle diagnostischen und prognostischen Studien sind beobachtende Studien </li></ul><ul><li>Sehr wichtig in Epidemiologie und Public Health </li></ul>
  13. 14. Beobachtende Studien <ul><li>Beobachtende Studien anfällig für </li></ul><ul><ul><li>Bias und confounding </li></ul></ul><ul><ul><li>Berichterstattung oft intransparent / unvollständig </li></ul></ul><ul><ul><li>Resultate werden oft überinterpretiert </li></ul></ul><ul><ul><li>Resultate führen oft zu Verunsicherung (“ health scares”) </li></ul></ul>
  14. 15. ISBN: 0953910822 Health scares: Newspaper reports which make people feel unnecessarily worried
  15. 17. Smoking and suicide
  16. 18. Smoking and homicide <ul><li>Non-smoker 1.00 </li></ul><ul><li>1-2 packs/day 1.71 (1.29-2.28) </li></ul><ul><li>2+ packs/day 2.04 (1.32-3.15) </li></ul>
  17. 20. Geschichte von STROBE <ul><li>Mar 2001 Idee zum ersten Mal diskutiert </li></ul><ul><li>Nov 2001 Erstes Meeting in Bristol </li></ul><ul><li>Apr 2003 Planungsmeeting </li></ul><ul><li>Aug 2003 Präsentation am World Epidemiology Conference in Montréal </li></ul><ul><li>Mai 2003 Gesuch an European Science Foundation </li></ul><ul><li>Sep 2004 Workshop in Bristol </li></ul><ul><li>Mai 2005 Erste Version einer Checkliste auf Website </li></ul><ul><li>… . </li></ul><ul><li>Okt 2007 Publikation </li></ul>
  18. 21. STROBE collaborators <ul><li>Co-ordinating group </li></ul><ul><ul><li>Douglas Altman, Matthias Egger, Stuart Pocock, Peter C. Gøtzsche, Erik von Elm, Jan Vandenbroucke </li></ul></ul><ul><li>Methodologists and practitioners </li></ul><ul><ul><li>Maria Blettner, Geneviève Chêne, Gian Luca Di Tanna, Sander Greenland, Metin Gulmezoglu, Bruno Ledergerber, Richard Lilford, David Moher, Hal Morgenstern, Dietrich Rothenbacher, Caroline Sabin, Lale Say, James J. Schlesselman, Jonathan Sterne </li></ul></ul>
  19. 22. <ul><li>Journal editors </li></ul><ul><ul><li>George Davey Smith ( IJE ) Frank Davidoff ( Annals of Internal Medicine ) Ana Garcia ( JECH ) Phil Greenland ( Archives of Internal Medicine ) Astrid James ( The Lancet ) Giselle Jones ( BMJ ) Hooman Momen ( Bulletin WHO ) Margaret McCann ( Epidemiology ) Alfredo Morabia ( Int J Public Health ) Cynthia Mulrow ( Annals of Internal Medicine ) Drummond Rennie ( JAMA ) Kenneth Rothman ( Epidemiology ) Donna Stroup ( Journal of the American Statistical Association ) </li></ul></ul>
  20. 23. Ziele <ul><li>Entwicklung einer Checkliste für Kohorten, Fall-Kontroll und Querschnittsstudien </li></ul><ul><li>Kurzer Artikel mit Checkliste und einer Beschreibung des Entwicklungsprozesses </li></ul><ul><li>Langer Hintergrundartikel (“Explanation and elaboration”) </li></ul><ul><li>Open access als Bedingung für die Publikation </li></ul>
  21. 24. Iterationen … <ul><li>Unzählige Revisionen der Checkliste </li></ul><ul><ul><li>“ Many small improvements can lead to a big overall improvement” </li></ul></ul><ul><li>Unzählige Drafts des langen Explanation and Elaboration Artikles </li></ul><ul><ul><li>Mindestens 10 Treffen mit den Autoren </li></ul></ul>
  22. 27. Final STROBE checklist <ul><li>TITLE and ABSTRACT   </li></ul><ul><li>INTRODUCTION   </li></ul><ul><li>Background/rationale  </li></ul><ul><li>Objectives   </li></ul><ul><li>METHODS  </li></ul><ul><li>Study design  </li></ul><ul><li>Setting  </li></ul><ul><li>Participants </li></ul><ul><li>Variables  </li></ul><ul><li>Data sources/measurement  </li></ul><ul><li>Bias  </li></ul><ul><li>Study size  </li></ul><ul><li>Quantitative variables     </li></ul><ul><li>Statistical methods </li></ul><ul><li>RESULTS   </li></ul><ul><li>Participants </li></ul><ul><li>Descriptive data  </li></ul><ul><li>Outcome data </li></ul><ul><li>Main results </li></ul><ul><li>Other analyses  </li></ul><ul><li>DISCUSSION   </li></ul><ul><li>Key results  </li></ul><ul><li>Limitations  </li></ul><ul><li>Interpretation   </li></ul><ul><li>Generalisability   </li></ul><ul><li>OTHER INFORMATION  </li></ul><ul><li>Funding   </li></ul>22 (34) items
  23. 31. Einige ‘key items’ <ul><li>Item 7 Variables </li></ul><ul><li>Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable. </li></ul><ul><li>Item 9 Bias </li></ul><ul><li>Describe any efforts to address potential sources of bias. </li></ul>
  24. 32. <ul><li>Item 11 Quantitative variables     </li></ul><ul><li>Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen, and why. </li></ul>
  25. 33. <ul><li>Item 16 Main Results </li></ul><ul><li>(a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (eg, 95% confidence intervals). Make clear which confounders were adjusted for and why they were included. </li></ul><ul><li>(b) Report category boundaries when continuous variables were categorised. </li></ul><ul><li>(c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period. </li></ul>
  26. 34. www.strobe-statement.org
  27. 35. www.equator-network.org

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