STROBE Statement

The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies
Erik von Elm, Douglas G Altman, Matthias Egger, Stuart J Pocock, Peter C Gtzsche, Jan P Vandenbroucke, for the STROBE initiative

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 studys 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 dened 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 e-mail 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, abstract, introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specic for cohort, case-control, or cross-sectional studies. A detailed explanation and elaboration document is published separately and is freely available on the websites 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.

Lancet 2007; 370: 145357 Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland (E von Elm MD, Prof M Egger MD); Centre for Statistics in Medicine, University of Oxford, Oxford, UK (Prof D G Altman DSc); Department of Social Medicine, University of Bristol, Bristol, UK (M Egger); London School of Hygiene and Tropical Medicine, University of London, London, UK (Prof S J Pocock PhD); Nordic Cochrane Centre, Copenhagen, Denmark (P C Gtzsche MD); and Department of Clinical Epidemiology, Leiden University Hospital, Leiden, Netherlands (Prof J P Vandenbroucke MD) Correspondence to: Dr Erik von Elm, Institute of Social and Preventive Medicine (ISPM), University of Bern, Finkenhubelweg 11, CH-3012 Bern, Switzerland [email protected]

Introduction
Many questions in medical research are investigated in observational studies.1 Much of the research into the cause of diseases relies on cohort, case-control, or cross-sectional studies. Observational studies also have a role in research into the benets and harms of medical interventions.2 Randomised trials cannot answer all important questions about a given intervention. For example, observational studies are more suitable to detect rare or late adverse eects of treatments, and are more likely to provide an indication of what is achieved in daily medical practice.3 Research should be reported transparently so that readers can follow what was planned, what was done, what was found, and what conclusions were drawn. The credibility of research depends on a critical assessment by others of the strengths and weaknesses in study design, conduct, and analysis. Transparent reporting is also needed to judge whether and how results can be included in systematic reviews.4,5 However, in published observational research important information is often missing or unclear. 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.6 Only a few reports of case-control studies in psychiatry explained the methods used to identify cases and controls.7 In a survey of longitudinal studies in stroke research, 17 of 49 articles (35%) did not specify the eligibility criteria.8 Others have argued that without sucient clarity of reporting, the benets of research might be achieved more slowly,9 and that there is a need for guidance in reporting observational studies.10,11 Recommendations on the reporting of research can improve reporting quality. The Consolidated Standards of Reporting Trials (CONSORT) statement was develwww.thelancet.com Vol 370 October 20, 2007

oped in 1996 and revised 5 years later.12 Many medical journals supported this initiative,13 which has helped to improve the quality of reports of randomised trials.14,15 Similar initiatives have followed for other research areaseg, for the reporting of meta-analyses of randomised trials16 or diagnostic studies.17 We established a network of methodologists, researchers, and journal editors to develop recommendations for the reporting of observational research: the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement.

Aims and use of the STROBE statement

The STROBE statement is a checklist of items that should be addressed in articles reporting on the three main study designs of analytical epidemiology: cohort, case-control, and cross-sectional studies. The intention is solely to provide guidance on how to report observational research well: these recommendations are not prescriptions for designing or conducting studies. Also, while clarity of reporting is a prerequisite to evaluation, the checklist is not an instrument to evaluate the quality of observational research. Here we present the STROBE statement and explain how it was developed. In a detailed companion paper, the explanation and elaboration article,1820 we justify the inclusion of the dierent checklist items and give methodological background and published examples of what we consider transparent reporting. We strongly recommend using the STROBE checklist in conjunction with the explanatory article, which is available freely on the websites of PLoS Medicine (www.plosmedicine.org), Annals of Internal Medicine (www.annals.org), and Epidemiology (www.epidem.com).
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STROBE Statement

Item Recommendation

Reported on manuscript page

Title and abstract 1 Introduction Background/rationale 2 Objectives Methods Study design Setting Participants 4 5 6 Present key elements of study design early in the paper Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection (a) Cohort studygive the eligibility criteria, and the sources and methods of selection of participants. Describe methods of follow-up Case-control studygive the eligibility criteria, and the sources and methods of case ascertainment and control selection. Give the rationale for the choice of cases and controls Cross-sectional studygive the eligibility criteria, and the sources and methods of selection of participants (b) Cohort studyfor matched studies, give matching criteria and number of exposed and unexposed Case-control studyfor matched studies, give matching criteria and the number of controls per case Variables Data sources/ measurement Bias Study size Statistical methods 7 8* 9 10 12 Clearly dene all outcomes, exposures, predictors, potential confounders, and eect modiers. Give diagnostic criteria, if applicable For each variable of interest give sources of data and details of methods of assessment (measurement). Describe comparability of assessment methods if there is more than one group Describe any eorts to address potential sources of bias Explain how the study size was arrived at Explain how quantitative variables were handled in the analyses. If applicable, describe which groupings were chosen, and why (a) Describe all statistical methods, including those used to control for confounding (b) Describe any methods used to examine subgroups and interactions (c) Explain how missing data were addressed (d) Cohort studyif applicable, explain how loss to follow-up was addressed Case-control studyif applicable, explain how matching of cases and controls was addressed Cross-sectional studyif applicable, describe analytical methods taking account of sampling strategy (e) Describe any sensitivity analyses Results Participants 13* (a) Report the numbers of individuals at each stage of the studyeg, numbers potentially eligible, examined for eligibility, conrmed eligible, included in the study, completing follow-up, and analysed (b) Give reasons for non-participation at each stage (c) Consider use of a ow diagram Descriptive data 14* (a) Give characteristics of study participants (eg, demographic, clinical, social) and information on exposures and potential confounders (b) Indicate the number of participants with missing data for each variable of interest (c) Cohort studysummarise follow-up time (eg, average and total amount) Outcome data 15* Cohort studyreport numbers of outcome events or summary measures over time Case-control studyreport numbers in each exposure category, or summary measures of exposure Cross-sectional studyreport numbers of outcome events or summary measures (a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (eg, 95% condence interval). 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 Other analyses Discussion Key results Limitations Interpretation Generalisability Other information Funding 22 Give the source of funding and the role of the funders for the present study and, if applicable, for the original study on which the present article is based 18 19 20 21 Summarise key results with reference to study objectives Discuss limitations of the study, taking into account sources of potential bias or imprecision. Discuss both direction and magnitude of any potential bias Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies, and other relevant evidence Discuss the generalisability (external validity) of the study results 17 Report other analyses doneeg, analyses of subgroups and interactions, and sensitivity analyses 3 Explain the scientic background and rationale for the investigation being reported State specic objectives, including any prespecied hypotheses (a) Indicate the studys design with a commonly used term in the title or the abstract (b) Provide in the abstract an informative and balanced summary of what was done and what was found

Quantitative variables 11

Main results

16

*Give such information separately for cases and controls in case-control studies, and, if applicable, for exposed and unexposed groups in cohort and cross-sectional studies. An explanation and elaboration article discusses each checklist item and gives methodological background and published examples of transparent reporting. The STROBE checklist is best used in conjunction with this article (freely available on the websites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology). Separate versions of the checklist for cohort, case-control, and cross-sectional studies are available on the STROBE website.

Table: The STROBE statementchecklist of items that should be addressed in reports of observational studies

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STROBE Statement

Development of the STROBE statement

We established the STROBE initiative in 2004, obtained funding for a workshop, and set up a website (www. strobe-statement.org). We searched textbooks, bibliographic databases, reference lists, and personal les for relevant material, including previous recommendations, empirical studies of reporting, and articles describing relevant methodological research. Because observational research makes use of many dierent study designs, we felt that the scope of STROBE had to be clearly dened early on. We decided to focus on the three study designs that are used most widely in analytical observational research: cohort, case-control, and cross-sectional studies. We organised a 2-day workshop in Bristol, UK, in September, 2004. 23 individuals attended this meeting, including editorial sta from Annals of Internal Medicine, BMJ, Bulletin of the World Health Organization, International Journal of Epidemiology, JAMA, Preventive Medicine, and The Lancet, as well as epidemiologists, methodologists, statisticians, and practitioners from Europe and North America. Written contributions were sought from ten other individuals who declared an interest in contributing to STROBE, but could not attend. Three working groups identied items deemed to be important to include in checklists for each type of study. A provisional list of items prepared in advance (available from our website) was used to facilitate discussions. The three draft checklists were then discussed by all participants and, where possible, items were revised to make them applicable to all three study designs. In a nal plenary session, the group decided on the strategy for nalising and disseminating the STROBE statement. After the workshop we drafted a combined checklist including all three designs and made it available on our website. We invited participants and additional scientists and editors to comment on this draft checklist. We subsequently published three revisions on the website, and two summaries of comments received and changes made. During this process the coordinating group (ie, the authors of the present paper) met on eight occasions for 1 or 2 days and held several telephone conferences to revise the checklist and to prepare the present paper and the explanation and elaboration paper.1820 The coordinating group invited three additional co-authors with methodological and editorial expertise to help write the explanation and elaboration paper, and sought feedback from more than 30 people, who are listed at the end of this paper. We allowed several weeks for comments on subsequent drafts of the paper and reminded collaborators about deadlines by e-mail.

methods (items 412), results (items 1317), and discussion sections (items 1821), and other information (item 22 on funding). 18 items are common to all three designs, while four (items 6, 12, 14, and 15) are design-specic, with dierent versions for all or part of the item. For some items (indicated by asterisks), information should be given separately for cases and controls in case-control studies, or exposed and unexposed groups in cohort and cross-sectional studies. Although presented here as a single checklist, separate checklists are available for each of the three study designs on the STROBE website.

For more on the STROBE initiative see www.strobe-statement.org

Implications and limitations

The STROBE statement was developed to assist authors when writing up analytical observational studies, to support editors and reviewers when considering such articles for publication, and to help readers when critically appraising published articles. We developed the checklist through an open process, taking into account the experience gained with previous initiatives, in particular CONSORT. We reviewed the relevant empirical evidence as well as methodological work, and subjected consecutive drafts to an extensive iterative process of consultation. The checklist presented here is thus based on input from a large number of individuals with diverse backgrounds and perspectives. The comprehensive explanatory article,1820 which is intended for use alongside the checklist, also beneted greatly from this consultation process. Observational studies serve a wide range of purposes, on a continuum from the discovery of new ndings to the conrmation or refutation of previous ndings.1820 Some studies are essentially exploratory and raise interesting hypotheses. Others pursue clearly dened hypotheses in available data. In yet another type of studies, the collection of new data is planned carefully on the basis of an existing hypothesis. We believe the present checklist can be useful for all these studies, since the readers always need to know what was planned (and what was not), what was done, what was found, and what the results mean. We acknowledge that STROBE is currently limited to three main observational study designs. We would welcome extensions that adapt the checklist to other designseg, case-crossover studies or ecological studiesand also to specic topic areas. Four extensions are now available for the CONSORT statement.2124 A rst extension to STROBE is underway for gene-disease association studies: the STROBE Extension to Genetic Association studies (STREGA) initiative.25 We ask those who aim to develop extensions of the STROBE statement to contact the coordinating group rst to avoid duplication of eort. The STROBE statement should not be interpreted as an attempt to prescribe the reporting of observational research in a rigid format. The checklist items should be addressed in sucient detail and with clarity somewhere in an article, but the order and format for presenting information
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STROBE components
The STROBE statement is a checklist of 22 items that we consider essential for good reporting of observational studies (table). These items relate to the articles title and abstract (item 1), the introduction (items 2 and 3),
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depends on author preferences, journal style, and the traditions of the research eld. For instance, we discuss the reporting of results under a number of separate items, while recognising that authors might address several items within a single section of text or in a table. Also, item 22, on the source of funding and the role of funders, could be addressed in an appendix or in the methods section of the article. We do not aim at standardising reporting. Authors of randomised clinical trials were asked by an editor of a specialist medical journal to CONSORT their manuscripts on submission.26 We believe that manuscripts should not be STROBEd, in the sense of regulating style or terminology. We encourage authors to use narrative elements, including the description of illustrative cases, to complement the essential information about their study, and to make their articles an interesting read.27 We emphasise that the STROBE statement was not developed as a tool for assessing the quality of published observational research. Such instruments have been developed by other groups and were the subject of a recent systematic review.28 In the explanation and elaboration paper, we used several examples of good reporting from studies whose results were not conrmed in further researchthe important feature was the good reporting, not whether the research was of good quality. However, if STROBE is adopted by authors and journals, issues such as confounding, bias, and generalisability could become more transparent, which might help temper the over-enthusiastic reporting of new ndings in the scientic community and popular media,29 and improve the methodology of studies in the long term. Better reporting may also help to have more informed decisions about when new studies are needed, and what they should address. We did not undertake a comprehensive systematic review for each of the checklist items and subitems, or do our own research to ll gaps in the evidence base. Further, although no one was excluded from the process, the composition of the group of contributors was inuenced by existing networks and was not representative in terms of geography (it was dominated by contributors from Europe and North America) and probably was not representative in terms of research interests and disciplines. We stress that STROBE and other recommendations on the reporting of research should be seen as evolving documents that require continual assessment, renement, and, if necessary, change. We welcome suggestions for the further dissemination of STROBEeg, by re-publication of the present article in specialist journals and in journals published in other languages. Groups or individuals who intend to translate the checklist to other languages should consult the coordinating group beforehand. We will revise the checklist in the future, taking into account comments, criticism, new evidence, and experience from its use. We invite readers to submit their comments via the STROBE website.
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Contributors The following individuals have contributed to the content and elaboration of the STROBE statement: Douglas G Altman, Maria Blettner, Paolo Boetta, Hermann Brenner, Genevive Chne, Cyrus Cooper, George Davey-Smith, Erik von Elm, Matthias Egger, France Gagnon, Peter C Gtzsche, Philip Greenland, Sander Greenland, Claire Infante-Rivard, John Ioannidis, Astrid James, Giselle Jones, Bruno Ledergerber, Julian Little, Margaret May, David Moher, Hooman Momen, Alfredo Morabia, Hal Morgenstern, Cynthia D Mulrow, Fred Paccaud, Stuart J Pocock, Charles Poole, Martin Rsli, Dietrich Rothenbacher, Kenneth Rothman, Caroline Sabin, Willi Sauerbrei, Lale Say, James J Schlesselman, Jonathan Sterne, Holly Syddall, Jan P Vandenbroucke, Ian White, Susan Wieland, Hywel Williams, Guang Yong Zou. Conict of interest statement We declare that we have no conict of interest. Acknowledgments The workshop was funded by the European Science Foundation (ESF). Additional funding was received from the Medical Research Council Health Services Research Collaboration, and the National Health Services Research and Development Methodology Programme. We are grateful to Gerd Antes, Kay Dickersin, Shah Ebrahim, and Richard Lilford for supporting the STROBE initiative. We are grateful to the following institutions that have hosted working meetings of the coordinating group: Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland; Department of Social Medicine, University of Bristol, Bristol, UK; London School of Hygiene and Tropical Medicine, London, UK; Nordic Cochrane Centre, Copenhagen, Denmark; and Centre for Statistics in Medicine, Oxford, UK. We are grateful to six reviewers who provided helpful comments on a previous draft of this paper. References 1 Glasziou P, Vandenbroucke JP, Chalmers I. Assessing the quality of research. BMJ 2004; 328: 3941. 2 Black N. Why we need observational studies to evaluate the eectiveness of health care. BMJ 1996; 312: 121518. 3 Papanikolaou PN, Christidi GD, Ioannidis JP. Comparison of evidence on harms of medical interventions in randomized and nonrandomized studies. CMAJ 2006; 174: 63541. 4 Jni P, Altman DG, Egger M. Systematic reviews in health care: assessing the quality of controlled clinical trials. BMJ 2001; 323: 4246. 5 Egger M, Schneider M, Davey Smith G. Spurious precision? Meta-analysis of observational studies. BMJ 1998; 316: 14044. 6 Pocock SJ, Collier TJ, Dandreo KJ, et al. Issues in the reporting of epidemiological studies: a survey of recent practice. BMJ 2004; 329: 883. 7 Lee W, Bindman J, Ford T, et al. Bias in psychiatric case-control studies: literature survey. Br J Psychiatry 2007; 190: 20409. 8 Tooth L, Ware R, Bain C, Purdie DM, Dobson A. Quality of reporting of observational longitudinal research. Am J Epidemiol 2005; 161: 28088. 9 Bogardus ST Jr, Concato J, Feinstein AR. Clinical epidemiological quality in molecular genetic research: the need for methodological standards. JAMA 1999; 281: 191926. 10 Anon. Guidelines for documentation of epidemiologic studies. Epidemiology Work Group of the Interagency Regulatory Liaison Group. Am J Epidemiol 1981; 114: 60913. 11 Rennie D. CONSORT revised improving the reporting of randomized trials. JAMA 2001; 285: 200607. 12 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: 119194. 13 Moher D, Altman DG, Schulz KF, Elbourne DR. Opportunities and challenges for improving the quality of reporting clinical research: CONSORT and beyond. CMAJ 2004; 171: 34950. 14 Plint AC, Moher D, Morrison A, et al. Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. Med J Aust 2006; 185: 26367. 15 Egger M, Jni P, Bartlett C. Value of ow diagrams in reports of randomized controlled trials. JAMA 2001; 285: 199699.

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Campbell MK, Elbourne DR, Altman DG. CONSORT statement: extension to cluster randomised trials. BMJ 2004; 328: 70208. 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: 115260. Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med 2006; 144: 36467. Ioannidis JP, Gwinn M, Little J, et al. A road map for ecient and reliable human genome epidemiology. Nat Genet 2006; 38: 35. Ormerod AD. CONSORT your submissions: an update for authors. Br J Dermatol 2001; 145: 37879. Schriger DL. Suggestions for improving the reporting of clinical research: the role of narrative. Ann Emerg Med 2005; 45: 43743. 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: 66676. Bartlett C, Sterne J, Egger M. What is newsworthy? Longitudinal study of the reporting of medical research in two British newspapers. BMJ 2002; 325: 8184. 2007 The Authors

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