(STROBE): One year on - EPI 2008
(STROBE): One year on - EPI 2008
(STROBE): One year on - EPI 2008
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Strengthening the Reporting of Observati<strong>on</strong>al<br />
Studies in Epidemiology (<str<strong>on</strong>g>STROBE</str<strong>on</strong>g>):<br />
<str<strong>on</strong>g>One</str<strong>on</strong>g> <str<strong>on</strong>g>year</str<strong>on</strong>g> <strong>on</strong><br />
Matthias Egger<br />
Institute of Social & Preventive Medicine (ISPM)<br />
University of Bern<br />
Switzerland<br />
www.ispm.ch
Outline<br />
• Rati<strong>on</strong>ale<br />
• Development<br />
• The checklist and E&E paper<br />
• Support and critique<br />
• Implementati<strong>on</strong> by journals<br />
• Your experiences and views
Background<br />
• Articles reporting studies should written such<br />
that the reader can evaluate the informati<strong>on</strong><br />
and reach his or her own c<strong>on</strong>clusi<strong>on</strong>s about<br />
results<br />
• Assessment of reliability of much published<br />
research is hampered by inadequate reporting<br />
• Authors and journals have an obligati<strong>on</strong> to<br />
ensure that research is reported adequately
„We recommend that editors improve the<br />
reporting of clinical trials by giving authors a<br />
list of the important items to be reported.“
Reporting guidelines<br />
1996 CONSORT RCTs<br />
1999 QUOROM Meta-analyses of RCTs<br />
new: PRISMA<br />
2001 CONSORT II RCTs<br />
2003 STARD Diagnostic studies<br />
2005 REMARK Tumour marker studies<br />
2007 <str<strong>on</strong>g>STROBE</str<strong>on</strong>g> Case-c<strong>on</strong>trol studies<br />
Cross-secti<strong>on</strong>al studies<br />
Cohort studies
• “Our readers would be amazed to learn<br />
how often we have to remind authors to<br />
simply menti<strong>on</strong> where and when their<br />
study was c<strong>on</strong>ducted.”<br />
Alfredo Morabia, Editor, Preventive Medicine
Cohort studies published in Antiviral<br />
Therapy 2005-2007 (n=33)<br />
• Loss to follow up defined: 9%<br />
• Descripti<strong>on</strong> of how loss to follow up was<br />
addressed in the analysis 59%<br />
• No. of patients lost to follow up reported 33%<br />
• Comparis<strong>on</strong> of patients lost with<br />
patients not lost to follow up 3%<br />
Antiviral Therapy, in press
Cohort studies published in STI or STD<br />
2004-2007 (n=60)<br />
• Inclusi<strong>on</strong> criteria described 93%<br />
• Outcomes and diagnostic criteria defined 65%<br />
• Censoring strategies described 47%<br />
• Baseline characteristics described 53%<br />
• Length of follow-up given 50%<br />
• No. of patients lost to follow up given 40%<br />
Sexually Transmitted Infecti<strong>on</strong>s, in press
History of <str<strong>on</strong>g>STROBE</str<strong>on</strong>g><br />
Mar 2001<br />
Nov 2001<br />
Apr 2003<br />
Aug 2003<br />
Sep 2004<br />
May 2005<br />
….<br />
Oct 2007<br />
Idea was first discussed<br />
Discussi<strong>on</strong> meeting<br />
Planning meeting<br />
Idea presented at World Epidemiology<br />
C<strong>on</strong>ference in M<strong>on</strong>treal<br />
Workshop in Bristol, Grant from<br />
European Science Foundati<strong>on</strong><br />
Posted 1 st draft checklist <strong>on</strong> website<br />
Publicati<strong>on</strong>
Over 40 c<strong>on</strong>tributors
Journal editors<br />
George Davey Smith (IJE)<br />
Phil Greenland (Archives of Internal Medicine)<br />
Astrid James (The Lancet)<br />
Giselle J<strong>on</strong>es (BMJ)<br />
Hooman Momen (Bulletin WHO)<br />
Alfredo Morabia (Preventive Medicine)<br />
Cynthia Mulrow (Annals of Internal Medicine)<br />
Drumm<strong>on</strong>d Rennie (JAMA)<br />
Kenneth Rothman (Former, Epidemiology)<br />
D<strong>on</strong>na Stroup (JASA)
Evoluti<strong>on</strong> of item <strong>on</strong> “Study size”<br />
First versi<strong>on</strong><br />
• “Describe how sample size was determined,<br />
including practical and statistical<br />
c<strong>on</strong>siderati<strong>on</strong>s.”<br />
Intermediate versi<strong>on</strong><br />
• “Describe rati<strong>on</strong>ale for study size, including<br />
practical and statistical c<strong>on</strong>siderati<strong>on</strong>s.”<br />
Final<br />
• “Explain how the study size was arrived at.”
www.strobe-statement.org
Translati<strong>on</strong>s
<str<strong>on</strong>g>STROBE</str<strong>on</strong>g> checklist<br />
TITLE and ABSTRACT<br />
INTRODUCTION<br />
Background/rati<strong>on</strong>ale<br />
Objectives<br />
METHODS<br />
Study design<br />
Setting<br />
Participants<br />
Variables<br />
Data sources/measurement<br />
Bias<br />
Study size<br />
Quantitative variables<br />
Statistical methods<br />
RESULTS<br />
Participants<br />
Descriptive data<br />
Outcome data<br />
Main results<br />
Other analyses<br />
DISCUSSION<br />
Key results<br />
Limitati<strong>on</strong>s<br />
Interpretati<strong>on</strong><br />
Generalisability<br />
OTHER INFORMATION<br />
Funding
Support and critique
Support<br />
• „An important and timely initiative“<br />
• „An excellent approach“<br />
• „A useful reference for those who wish to publish<br />
and critique“<br />
• „A major step forward“<br />
• „A most important step forward“<br />
• „...will likely make a str<strong>on</strong>g c<strong>on</strong>tributi<strong>on</strong> to<br />
improving the quality of reporting“<br />
• „A useful service for the epidemiological<br />
community“
Support<br />
• „...will c<strong>on</strong>tribute to widening the spectrum of<br />
what evidence the scientific c<strong>on</strong>sensus regards<br />
as acceptable“<br />
• „<str<strong>on</strong>g>STROBE</str<strong>on</strong>g> should provide clinical research with a<br />
new impetus toward valuing observati<strong>on</strong>al<br />
studies“
Critique and c<strong>on</strong>cerns<br />
• „This smacks of c<strong>on</strong>descensi<strong>on</strong>“<br />
• „...will be found in any text targeted at<br />
Masters students“
Journals that published the 100 most recent<br />
articles indexed as ‘cohort studies’<br />
• Acta Derm Venereol (1)<br />
• Acta Myol (1)<br />
• Am J Health Syst Pharm (1)<br />
• Am J Transplant (1)<br />
• Arch Br<strong>on</strong>c<strong>on</strong>eumol (2)<br />
• Arch Phys Med Rehabil (1)<br />
• Arch Surg (5)<br />
• Arterioscler Thromb Vasc Biol (4)<br />
• Asian J Surg (2)<br />
• BJOG (1)<br />
• BMC Genet (1)<br />
• Can J Gastroenterol (1)<br />
• Can Respir J (1)<br />
• Cancer Causes C<strong>on</strong>trol (3)<br />
• Circulati<strong>on</strong> (1)<br />
• Clin Implant Dent Relat Res (1)<br />
• Clin Nephrol (1)<br />
• Clin Ther (1)<br />
• Community Dent Health (3)<br />
• Curr Diab Rep (1)<br />
• Epidemiology (3)<br />
• Eur J Cardiothorac Surg (2)<br />
• Eur J Clin Pharmacol (1)<br />
• Eur J Nucl Med Mol Imaging (1)<br />
• Haematologica (1)<br />
• Heart Surg Forum (3)<br />
• Hypertensi<strong>on</strong> (9)<br />
• Int J Technol Assess Health Care (1)<br />
• J Am Coll Cardiol (6)<br />
• J Fam Pract (2)<br />
• J Hum Genet (1)<br />
• J Hypertens (3)<br />
• J Infect (1)<br />
• J Korean Med Sci (2)<br />
• J Neurosurg (1)<br />
• J Neurovirol (1)<br />
• J Nutr (1)<br />
• J Oral Sci (1)<br />
• J Prosthet Dent (1)<br />
• J Surg Oncol (2)<br />
• J Surg Res (1)<br />
• Lancet (1)<br />
• Lung Cancer (3)<br />
• Med J Aust (1)<br />
• Methods Mol Biol (1)<br />
• Mol Med (1)<br />
• Nephrol Dial Transplant (2)<br />
• Neurosurgery (1)<br />
• Nord J Psychiatry (2)<br />
• Otolaryngol Head Neck Surg (1)<br />
• Pediatr Infect Dis J (1)<br />
• Phys Med Biol (1)<br />
• Psychiatr Serv (1)<br />
• Respir Res (1)<br />
• Rev Invest Clin (1)<br />
• Rev Med Chir Soc Med Nat Iasi (1)<br />
• Spine (2)<br />
• Stat Med (1)<br />
• World J Urol (1)<br />
Egger et al. IJE 2007
Critique and c<strong>on</strong>cerns<br />
• „...will lead to losses in the ‚discovery<br />
potential‘“<br />
• „...a breach in the capacity for scientific<br />
creativity“<br />
• „...ventures into matters of study c<strong>on</strong>duct“<br />
• „...will evolve into a tool for judging study“<br />
• „...we try to avoid judging an apple by how<br />
well it is polished“
Implementati<strong>on</strong> by journals
• Acta Gastroenterológica Latinoamericana<br />
• African Journal of Paediatric Surgery<br />
• American Journal of Kidney Diseases<br />
• American Journal of Preventive Medicine<br />
• American Journal of Respiratory and Critical Care Medicine<br />
• Annals of Behavioral Medicine<br />
• Annals of Cardiac Anaesthesia<br />
• Annals of Clinical Biochemistry<br />
• Annals of Emergency Medicine<br />
• Annals of Internal Medicine<br />
• Annals of Pediatric Cardiology<br />
• Annals of Saudi Medicine<br />
• Annals of Thoracic Medicine<br />
• Annals of Tropical Medicine & Public Health<br />
• Arab Journal of Nephrology and Transplantati<strong>on</strong><br />
• Archives of Public Health<br />
• Australian Family Physician<br />
• British Journal of Dermatology<br />
• British Medical Journal<br />
• Bulletin of the World Health Organizati<strong>on</strong><br />
• Butlletí<br />
• Cardiovascular Therapeutics<br />
• Chest<br />
• Chiropractic Journal of Australia<br />
• Clinical Toxicology<br />
• CNS Neuroscience & Therapeutics<br />
• Community Dentistry and Oral Epidemiology<br />
• Croatian Medical Journal<br />
• Down Syndrome Research and Practice<br />
• Drug and Alcohol Dependence<br />
• East African Journal of Public Health<br />
• Epidemiology & Infecti<strong>on</strong><br />
• European Journal of Oral Implantology<br />
• European Respiratory Journal<br />
• Global Health Acti<strong>on</strong><br />
• Gut<br />
• Hepatitis M<strong>on</strong>thly<br />
• Indian Journal of Medical Sciences<br />
• Indian Journal of Ophthalmology<br />
• Indian Journal of Pathology and Microbiology<br />
• Indian Pediatrics<br />
• Injury Preventi<strong>on</strong><br />
• Internati<strong>on</strong>al Journal of Clinical Practice<br />
• Internati<strong>on</strong>al Journal of Green Pharmacy<br />
• Internati<strong>on</strong>al Journal of Nursing Studies<br />
• Journal of Athletic Training<br />
• Journal of B<strong>on</strong>e and Joint Surgery<br />
• Journal of Cutaneous and Aesthetic Surgery<br />
• Journal of Cytology<br />
• Journal of Emergencies, Trauma and Shock<br />
• Journal of Gynecological Endoscopy and Surgery<br />
• Journal of Investigati<strong>on</strong>al Allergology & Clinical Immunology<br />
• Journal of Medical Ethics<br />
• Journal of Medical Sciences Research<br />
• Journal of Orthopaedic & Sports Physical Therapy<br />
• Journal of Postgraduate Medicine<br />
• Lancet<br />
• Lancet Neurology<br />
• Lancet Oncology<br />
• Medical Decisi<strong>on</strong> Making<br />
• Medical Law Cases - For Doctors<br />
• Nature Clinical Practice Cardiovascular Medicine<br />
• Neuroepidemiology<br />
• Obstetrics & Gynecology<br />
• Open Medicine<br />
• Pediatría<br />
• Pflegezeitschrift<br />
• Philippine Journal of Otolaryngology Head and Neck Surgery<br />
• Physical Therapy<br />
• PLoS Computati<strong>on</strong>al Biology<br />
• PLoS Genetics<br />
• PLoS ONE<br />
• PLoS Medicine<br />
• PLoS Neglected Tropical Diseases<br />
• PLoS Pathogens<br />
• pt Zeitschrift für Physiotherapeuten<br />
• Revista de Saude Publica<br />
• Revista Brasileira de Cirurgia Cardiovascular<br />
• Revista Peruana de Epidemiología<br />
• Scandinavian Journal of Work, Envir<strong>on</strong>ment & Health<br />
• Sexually Transmitted Infecti<strong>on</strong>
INSTRUÇÕES AOS AUTORES<br />
• Artigos Originais<br />
– Recomenda-se ao autor que antes de<br />
submeter seu artigo utilize o "checklist"<br />
corresp<strong>on</strong>dente:<br />
• <str<strong>on</strong>g>STROBE</str<strong>on</strong>g> para estudos observaci<strong>on</strong>ais em<br />
epidemiologia
Extensión y presentación del<br />
manuscrito<br />
• Se ac<strong>on</strong>seja a los autores a fin de evitar<br />
omitir elementos importantes revisar las<br />
guias de reporte anexadas a c<strong>on</strong>tinuación.
Implementati<strong>on</strong> by journals<br />
• „Please follow the <str<strong>on</strong>g>STROBE</str<strong>on</strong>g> guidelines“<br />
• “Please report your data using the <str<strong>on</strong>g>STROBE</str<strong>on</strong>g><br />
guidelines which are designed to improve the<br />
value of such reports”<br />
• “Authors are encouraged to c<strong>on</strong>sult …”<br />
• „Authors should use / c<strong>on</strong>sider / follow ...“<br />
• “Authors are requested / required to follow …”<br />
• „Authors are str<strong>on</strong>gly advised to refer to ...“<br />
• „We urge authors to follow ...“<br />
• „Authors need to adhere to ...“<br />
• „Must be reported according to ...“
• “We encourage creativity and originality and<br />
recognize that not all papers can or should<br />
meet these guidelines.“
• “We suggest that authors complete the<br />
<str<strong>on</strong>g>STROBE</str<strong>on</strong>g> checklist for submissi<strong>on</strong> with<br />
their articles.<br />
• In your cover letter, be sure to indicate that<br />
you have followed the <str<strong>on</strong>g>STROBE</str<strong>on</strong>g><br />
guidelines.<br />
• It is up to the authors to decide which of<br />
the checklist items are applicable to their<br />
study“
• “Please note that we need the <str<strong>on</strong>g>STROBE</str<strong>on</strong>g><br />
checklist for an observati<strong>on</strong>al study (as a<br />
supplemental file)”
Suggesti<strong>on</strong>s for improvements<br />
• Many helpful suggesti<strong>on</strong>s received<br />
• More are welcome!<br />
• Please submit yours at<br />
www.strobe-statement.org/Forum.html<br />
• All will be c<strong>on</strong>sidered in next revisi<strong>on</strong>
Thank you<br />
• Jan Vandenbroucke, Doug Altman, Erik<br />
v<strong>on</strong> Elm, <str<strong>on</strong>g>STROBE</str<strong>on</strong>g> group<br />
• Editors<br />
• Funders (about 20,000 UK£)<br />
– European Science foundati<strong>on</strong><br />
– Medical Research Council R&D<br />
– Medical Research Council HSRC<br />
– Swiss Nati<strong>on</strong>al Science Foundati<strong>on</strong>
Over to you