STROBEStrengthening the Reporting of

Observational Studies in Epidemiology

…und andere Reporting guidelines

Matthias EggerInstitut für Sozial- und Präventivmedizin

Universität Bernwww.ispm.ch

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• Warum brauchen wir „reporting guidelines“?

• Lehren aus CONSORT

• Beobachtende Studien

• Die STROBE Initiative

Transparenz im Publizieren von Forschungresultaten

• Wissenschaftliche Artikel sollten so geschrieben werden, dass der Leser die Qualität der Studie und die Bedeutung der Resultate wirklich evaluieren kann

• Die Beurteilung der Qualität publizierter Studien ist oft schwierig weil wichtige Aspekte fehlen oder unklar bleiben.

• Autoren und Journals haben eine Verpflichtung dafür zu sorgen, dass Studien transparent und vollständing berichtet werden.

Lancet 1996

“The patients were randomly assigned to receive either ...[treatment] ... or a similar number of placebo pills for three weeks. ...

The patients served as their own controls: in the next three weeks ... they received the other agent.“

Ein Beispiel: publiziert

“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. She was responsible for packaging and delivering the medications in sequence of her choice to the patients and kept her records at home. This was a crude method ... it worked for us.“

Was wirklich geschah

Unterlaufen der Randomisierung: Beispiel

Briefumschläge

• Lichtundurchlässig

• Verschlossen

• Fortlaufend nummeriert

• Log Buch

Schulz Lancet 1995

CONSORT

Consolidated Standards of Reporting Trials

www.consort-statement.org

En

roll

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tT

rea

tme

nt

all

oc

ati

on

Fo

llo

w u

pA

na

lys

is

Assessed foreligibility (n = …)

Allocated to treatment(n = …)

Received treatment asallocated (n = …)

Did not receive treatmentas allocated(give reasons) (n = …)

Excluded (n = …)

Not meeting inclusion criteria (n = …)

Refused to participate (n = …)

Other reasons (n = …)

Randomised (n = …)

Lost to follow up (n = …)(give reasons)

Discontinued treatment(n = …) (give reasons)

Excluded from analysis(give reasons) (n = …)

Analysed (n = …)

Allocated to treatment(n = …)

Received treatment asallocated (n = …)

Did not receive treatmentas allocated(give reasons) (n = …)

Lost to follow up (n = …)(give reasons)

Discontinued treatment(n = …) (give reasons)

Excluded from analysis(give reasons) (n = …)

Analysed (n = …)

CONSORTflow chart

Academic Emergency MedicineActa Neurologica ScandinaviaAdvances in Neonatal CareAfrican Journal of MedicineAIDSAlcohol and AlcoholismAlternative Therapies in Health and MedicineAmerican Journal of Occupational TherapyAmyotrophic Lateral Sclerosis and Other Motor Neuron DisordersAnesthesiologyAnnals of Behavioral MedicineAnnals of Clinical Microbiology and AntimicrobialsAnnals of Emergency MedicineAnnals of Family MedicineAnnals of General Hospital PsychiatryAnnals of Internal MedicineAnnals of NeurologyAnnals of OncologyAnnals of Rheumatic DiseasesArchives of DermatologyArchives of Disease in ChildhoodArchives of Family MedicineArchives of General PsychiatryArchives of Internal MedicineArchives of NeurologyArchives of OphthalmologyArchives of OtolaryngologyArchives of Pathology and Laboratory MedicineArchives of Pediatrics & Adolescent MedicineArchivesof SurgeryArmenian Medical Review JournalArthritis Research & TherapyAtencion PrimariaAustralian and New Zealand Journal of SurgeryBandolierBioMagnetic Research and TechnologyBrazilian Journal of Cardiovascular Surgery<British Dental JournalBritish Journal of DermatologyBritish Journal of Obstetrics & GynaecologyBritish Journal of OphthalmologyBritish Journal of SurgeryBMJCanadian Journal of AnesthesiaCanadian Journal of Emergency MedicineCanadian Journal of Infectious DiseasesCanadian Journal of Neurological SciencesCanadian Journal of Occupational TherapyCanadian Journal of Respiratory TherapyCanadian Medical Association JournalCancerCardiovascular DiabetologyCardiovascular UltrasoundChinese Medical JournalClimactericClinical and Molecular AllergyClinical ChemistryClinical Oral InvestigationsComparative HepatologyCost Effectiveness and Resource AllocationCroatian Medical Journal

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

Journal of the American College of Surgeons Journal of the American Geriatrics SocietyJournal of the American Medical AssociationJournal of the American Podiatric Medical AssociationJournal of the American Society of NephrologyJournal of the Canadian Chiropractic AssociationJournal of the Canadian Dental AssociationJournal of the National Cancer Institute Journal of the Society of Laparoendoscopic SurgeonsKinetoplastid Biology and DiseaseKuwait Medical Journal Lancet (The)Lancet Oncology (The)Malawi Medical JournalMayo Clinic ProceedingsMedical AcupunctureMedical ImmunologyMedical Journal of AustraliaMolecular PathologyMovement DisordersNational Medical Journal of IndiaNederlands Tijdschrift voor GeneeskundeNeurologyNeurology IndiaNeuropsychologyNew England Journal of MedicineNew Zealand Journal of Medical Laboratory ScienceNutrition Journal Obstetrics and GynecologyOnkologieOphthalmic and Physilogical OpticsOphthalmologyPalliative Medicine Pediatric PulmonologyPediatricsPhysical Therapy ReviewPhytomedicinePLoS MedicinePsychosomatic Medicine Radiotherapy & Oncology Reproductive Biology and EndocrinologyResuscitationRevista Brasileira de Cirurgia CardiovascularRevista Espanola de Alergol Immunol ClinicaRevista Espanola de Salud PublicaRevista Sanidad Militar de MexicoRheumatologyRinsho Hyoka (Clinical Evaluation)Sau Paulo Medical JournalScandinavian Journal of GastroenterologyDer SchmerzSexually Transmitted InfectionsSpineThrombosis JournalUgeskrift for LaegerVeterinary Journal (The)World Journal of Surgical OncologyZeitschrift für ärztliche Fortbildung und Qualitätssicherung

Faktoren für den Erfolg von CONSORT

• Kollaborativer, offener Prozess• Breite Beteiligung in der Gruppe

– Methodologen

– Klinische Forscher

– Editors

• Fokus auf Berichterstattung, nicht Durchführung• ‘Evidence-based’• Evaluationen• Publikationen in bekannten Journals

Beobachtende Studien

• Wichtig zur Erfassung unerwünschter Wirkungen

• Fast alle diagnostischen und prognostischen Studien sind beobachtende Studien

• Sehr wichtig in Epidemiologie und Public Health

Beobachtende Studien

• Beobachtende Studien anfällig für– Bias und confounding– Berichterstattung oft intransparent /

unvollständig– Resultate werden oft überinterpretiert– Resultate führen oft zu Verunsicherung

(“ health scares”)

ISBN: 0953910822

Health scares:

Newspaper reports which make people feel unnecessarily worried

Smoking and suicide

0.2 1 2 5 10 25

No of cigarettes

MRFIT screenees

Whitehall I

North Karelia men

Kuopio men

1-1414-24 25+

1-1414-24 25+

1-1414-24 25+

1-1414-24 25+

1-1414-24 25+

Meta-analysis

Relative rate (95% CI)

Smoking and homicide

• Non-smoker 1.00

• 1-2 packs/day 1.71 (1.29-2.28)

• 2+ packs/day 2.04 (1.32-3.15)

Geschichte von STROBE

Mar 2001 Idee zum ersten Mal diskutiert

Nov 2001 Erstes Meeting in Bristol

Apr 2003 Planungsmeeting

Aug 2003 Präsentation am World Epidemiology Conference in Montréal

Mai 2003 Gesuch an European Science Foundation

Sep 2004 Workshop in Bristol

Mai 2005 Erste Version einer Checkliste auf Website ….

Okt 2007 Publikation

STROBE collaborators

• Co-ordinating group– Douglas Altman, Matthias Egger, Stuart Pocock, Peter

C. Gøtzsche, Erik von Elm, Jan Vandenbroucke

• Methodologists and practitioners– 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

• Journal editors – 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)

Ziele

• Entwicklung einer Checkliste für Kohorten, Fall-Kontroll und Querschnittsstudien

• Kurzer Artikel mit Checkliste und einer Beschreibung des Entwicklungsprozesses

• Langer Hintergrundartikel (“Explanation and elaboration”)

• Open access als Bedingung für die Publikation

Iterationen …

• Unzählige Revisionen der Checkliste – “Many small improvements can lead to a big

overall improvement”

• Unzählige Drafts des langen Explanation and Elaboration Artikles– Mindestens 10 Treffen mit den Autoren

Final STROBE checklist

TITLE and ABSTRACT INTRODUCTION  Background/rationale  Objectives  

METHODS  Study design  Setting  Participants Variables  Data sources/measurement  Bias  Study size  Quantitative variables     Statistical methods

RESULTS  Participants Descriptive data  Outcome data Main results Other analyses 

DISCUSSION  Key results  Limitations  Interpretation   Generalisability  

OTHER INFORMATION  Funding  

22 (34) items

Einige ‘key items’

Item 7 Variables

Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable.

Item 9 Bias

Describe any efforts to address potential sources of bias.

Item 11 Quantitative variables   

Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen, and why.

Item 16 Main Results

(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.

(b) Report category boundaries when continuous variables were categorised.

(c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period.

www.strobe-statement.org

www.equator-network.org