The Strengthening the Reporting of Obrvational Studies in Epidemiology (STROBE) statement: guidelines for reporting obrvational studies
Erik von Elm, Douglas G Altman, Matthias Egger, Stuart J Pocock, Peter C Gøtzsche, Jan P Vandenbroucke, for the STROBE initiative
Much biomedical rearch is obrvational. The reporting of such rearch is often inadequate, which hampers the asssment of its strengths and weakness and of a study’s generalisability. The Strengthening the Reporting of Obrvational Studies in Epidemiology (STROBE) initiative developed recommendations on what should be included in an accurate and complete report of an obrvational study. We defi ned the scope of the recommendations to cover thre e main study de signs: cohort, ca-control, and cross- ctional studie s. We conve ne d a 2-day workshop in September, 2004, with methodologists, rearchers, and journal editors to draft a checklist of items. This list was subquently revid during veral meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account e mpirical e vide nce and me thodological conside rations. The workshop and the subquent 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 ctions of articles.
18 items are common to all three study designs and four are specifi c for cohort, ca-control, or cross-ctional studies.
A detailed explanation and elaboration document is published parately 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 obrvational studies.
Introduction
Many questions in medical rearch are investigated in obrvational studies.1Much of the rearch into the cau of dias relies on cohort, ca-control, or cross-ctional studies. Obrvational studies also have a role in rearch into the benefits and harms of medical interventions.2 Randomid trials cannot answer all important questions about a given intervention. For example, obrvational studies are more suitable to detect rare or late adver eff ects of treatments, and are more likely to provide an indication of what is achieved in daily medical practice.3 Rearch 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 rearch depends on a critical asssment by others of the strengths and weakness in study design, conduct, and analysis. Tran
sparent reporting is also needed to judge whether and how results can be included in systematic reviews.4,5 However, in published obrvational rearch 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 ca-control studies in psychiatry explained the methods ud to identify cas and controls.7 In a survey of longitudinal studies in stroke rearch, 17 of 49 articles (35%) did not specify the eligibility criteria.8 Others have argued that without sufficient clarity of reporting, the benefi ts of rearch might be achieved more slowly,9 and that there is a need for guidance in reporting obrvational studies.10,11 Recommendations on the reporting of rearch can improve reporting quality. The Consolidated Standards of Reporting Trials (CONSORT) statement was devel-oped in 1996 and revid 5 years later.12 Many medical
journals supported this initiative,13 which has helped to
improve the quality of reports of randomid trials.14,15
Similar initiatives have followed for other rearch
areas—eg, for the reporting of meta-analys of
randomid trials16 or diagnostic studies.17 We estab-
lished a network of methodologists, rearchers, and
journal editors to develop recommendations for the
reporting of obrvational rearch: the Strengthening
the Reporting of Obrvational Studies in Epidemiology
(STROBE) statement.
Aims and u of the STROBE statement
二苯胺试剂
The STROBE statement is a checklist of items that should
be addresd in articles reporting on the three main study
designs of analytical epidemiology: cohort, ca-control,
and cross-ctional studies. The intention is solely to
provide guidance on how to report obrvational rearch
well: the 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 obrvational
rearch.
Here we prent the STROBE statement and explain
how it was developed. In a detailed companion paper, the
explanation and elaboration article,18–20 we justify the
inclusion of the different checklist items and give
methodological background and published examples of
what we consider transparent reporting. We strongly
recommend using the STROBE checklist in conjunction
选股票with the explanatory article, which is available freely on the
websites of PLoS Medicine (www.plosmedicine), Annals
of Internal Medicine (www.annals), and Epidemiology
属马人().
Lancet 2007; 370: 1453–57
动物面具图片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 Gøtzsche 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,
bom成本Finkenhubelweg 11, CH-3012
Bern, Switzerland
strobe@ispm.unibe.ch
STROBE Statement
STROBE Statement
STROBE Statement
Development of the STROBE statement
We established the STROBE initiative in 2004, obtained funding for a workshop, and t up a website (www.strobe-statement). We arched textbooks,
bibliographic databas, reference lists, and personal fi les for relevant material, including previous recommendations, empirical studies of reporting, and articles describing relevant methodological rearch. Becau obrvational rearch makes u of many diff erent study designs, we felt that the scope of STROBE had to be clearly defi ned early on. We decided to focus on the three study designs that are ud most widely in analytical obrvational rearch: cohort, ca-control, and cross-ctional studies.We organid a 2-day workshop in Bristol, UK , in September, 2004. 23 individuals attended this meeting, including editorial staff from Annals of Internal Medicine , BMJ , Bulletin of the World Health Organization , Inter-national Journal of Epidemiology , JAMA , Prev e ntive 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 identifi ed 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 ud to facilitate discussions. The three draft checklists were then discusd by all participants and, where possible, items were revid to make them applicable to all three study designs. In a fi nal plenary ssion, the group decided on the strategy for fi nalising and disminating 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 subquently 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 prent paper) met on eight occasions for 1 or 2 days and held veral telephone conferences to revi the checklist and to prepare the prent paper and the explanation and elaboration paper.18–20 The coordinating group invited three additional co-authors with method o logical and editorial experti 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 veral weeks for comments on subquent drafts of the paper and reminded collaborators about deadlines by e-mail.STROBE components
The STROBE statement is a checklist of 22 items that we consider esntial for good reporting of obrvational studies (table). The items relate to the article’s title and abstract (item 1), the introduction (items 2 and 3), methods (items 4–12), results (items 13–17), and
discussion ctions (items 18–21), 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-specifi
c, with diff erent versions for all or part of the item. For some items (indicated by asterisks), information should be given parately for cas and controls in ca-control studies, or expod and unexpod groups in cohort and cross-ctional studies. Although prented here as a single checklist, parate checklists are available for each of the three study designs on the STROBE website.Implications and limitations
The STROBE statement was developed to assist authors when writing up analytical obrvational 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 conc-utive drafts to an extensive iterative process of consultation. The checklist prented here is thus bad on input from a large number of individuals with diver back-grounds and perspectives. The comprehensive explana t ory
article,18–20
which is intended for u alongside the check-list, also benefi ted greatly from this consultation process.Obrvational studies rve a wide range of purpos, on a continuum from the discovery of new fi ndings to the confi rmation or refutation of previous fi ndings.18–20 Some studies are esntially exploratory and rai interesting hypothes. Others pursue clearly defi ned hypothes 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 prent checklist can be uful for all the 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 obrvational study designs. We would welcome extensions that adapt the checklist to other designs—eg, ca-crossover studies or ecological
studies—and also to specifi
c topic areas. Four extensions are now available for the CONSORT statement.21–24 A fi rst extension to STROBE is underway for gene-dia association studies: the STROBE Extension to Genetic Association studies (STREGA) initiative.25 We ask tho who aim to develop extensions of the STROBE statement to contact the coordinating group fi rst to avoi
d duplication
of eff ort.
The STROBE statement should not be interpreted as an attempt to prescribe the reporting of obrvational rearch in a rigid format. The checklist items should be addresd
in suffi
cient detail and with clarity somewhere in an article, but the order and format for prenting information
好看连续剧
For more on the
STROBE initiative e www.strobe-statement
STROBE Statement
depends on author preferences, journal style, and the traditions of the rearch fi eld. For instance, we discuss the reporting of results under a number of parate items, while recognising that authors might address veral items within a single ction of text or in a table. Also, item 22, on the source of funding and the role of funders, could be addresd in an appendix or in the methods ction of the article. We do not aim at standardising reporting. Authors of randomid 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 n of regulating style or terminology. We encourage authors to u narrative elements, including the description of illustrative cas, to complement the esntial information about their study, and to make their articles an interesting read.27
居住证办理条件We emphasi that the STROBE statement was not developed as a tool for asssing the quality of published obrvational rearch. 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 ud veral examples of good reporting from studies who results were not confi rmed in further rearch—the important feature was the good reporting, not whether the rearch was of good qualit
y. 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 fi ndings in the scientific 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 rearch to fi ll gaps in the evidence ba. Further, although no one was excluded from the process, the composition of the group of contributors was infl uenced by existing networks and was not reprentative in terms of geography (it was dominated by contributors from Europe and North America) and probably was not reprentative in terms of rearch interests and disciplines. We stress that STROBE and other recommendations on the reporting of rearch should be en as evolving documents that require continual asssment, refinement, and, if necessary, change. We welcome suggestions for the further dismination of STROBE—eg, by re-publication of the prent 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 revi the checklist in the future, taking into account comments, criticism,
new evidence, and experience from its u. We invite readers to submit their comments via the STROBE website.Contributors
The following individuals have contributed to the content and elaboration of the STROBE statement: Douglas G Altman,
Maria Blettner, Paolo Boff etta, Hermann Brenner, Geneviève Chêne, Cyrus Cooper, George Davey-Smith, Erik von Elm, Matthias Egger, France Gagnon, Peter C Gøtzsche, Philip Greenland, Sander Greenland, Claire Infante-Rivard, John Ioannidis, Astrid James, Gille 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 Röösli, Dietrich Rothenbacher, Kenneth Rothman,
Caroline Sabin, Willi Sauerbrei, Lale Say, James J Schleslman, Jonathan Sterne, Holly Syddall, Jan P Vandenbroucke, Ian White, Susan Wieland, Hywel Williams, Guang Yong Zou.
Confl ict of interest statement
We declare that we have no confl ict of interest.
Acknowledgments
The workshop was funded by the European Science Foundation (ESF). Additional funding was received from the Medical Rearch Council Health Services Rearch Collaboration, and the National Health Services Rearch 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. Asssing the quality of
rearch. BMJ 2004; 328: 39–41.
2 Black N. Why we need obrvational studies to evaluate the
eff ectiveness of health care. BMJ 1996; 312: 1215–18.
3 Papanikolaou PN, Christidi GD, Ioannidis JP. Comparison of
evidence on harms of medical interventions in randomized and
nonrandomized studies. CMAJ 2006; 174: 635–41.
4 Jüni P, Altman DG, Egger M. Systematic reviews in health care:
asssing the quality of controlled clinical trials. BMJ 2001; 323:
42–46.
5 Egger M, Schneider M, Davey Smith G. Spurious precision?
Meta-analysis of obrvational studies. BMJ 1998; 316: 140–44.
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 ca-control
studies: literature survey. Br J Psychiatry 2007; 190: 204–09.
8 Tooth L, Ware R, Bain C, Purdie DM, Dobson A. Quality of
reporting of obrvational longitudinal rearch. Am J Epidemiol
2005; 161: 280–88.
9 Bogardus ST Jr, Concato J, Feinstein AR. Clinical epidemiological
quality in molecular genetic rearch: the need for methodological standards. JAMA 1999; 281: 1919–26.
10 Anon. Guidelines for documentation of epidemiologic studies.
Epidemiology Work Group of the Interagency Regulatory Liaison
Group. Am J Epidemiol 1981; 114: 609–13.
11 Rennie D. CONSORT revid – improving the reporting of
randomized trials. JAMA 2001; 285: 2006–07.
12 Moher D, Schulz KF, Altman DG. The CONSORT statement:
revid recommendations for improving the quality of reports of
parallel-group randomid trials. Lancet 2001; 357: 1191–94.
13 Moher D, Altman DG, Schulz KF, Elbourne DR. Opportunities and
challenges for improving the quality of reporting clinical rearch: CONSORT and beyond. CMAJ 2004; 171: 349–50.
14 Plint AC, Moher D, Morrison A, et al. Does the CONSORT checklist
improve the quality of reports of randomid controlled trials? A
systematic review. Med J Aust 2006; 185: 263–67.
15 Egger M, Jüni P, Bartlett C. Value of fl ow diagrams in reports of
randomized controlled trials. JAMA 2001; 285: 1996–99.
STROBE Statement
16 Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF.
Improving the quality of reports of meta-analys of randomid
controlled trials: the QUOROM statement. Quality of Reporting of Meta-analys. Lancet 1999; 354: 1896–900.
17 Bossuyt PM, Reitsma JB, Bruns DE, et al. Towards complete and
accurate reporting of studies of diagnostic accuracy: The STARD
Initiative. Ann Intern Med 2003; 138: 40–44.
18 Vandenbroucke JP, von Elm E, Altman DG, et al, for the STROBE
initiative. Strengthening the Reporting of Obrvational Studies in Epidemiology (STROBE): explanation and elaboration. PLoS Med
2007; 4: e297.
19 Vandenbroucke JP, von Elm E, Altman DG, et al, for the STROBE
initiative. Strengthening the Reporting of Obrvational Studies in Epidemiology (STROBE): explanation and elaboration. Ann Intern Med (in press).
20 Vandenbroucke JP von Elm E, Altman DG, et al, for the STROBE
initiative. Strengthening the Reporting of Obrvational Studies in Epidemiology (STROBE): explanation and elaboration. Epidemiology (in press).
21 Ioannidis JP, Evans SJ, Gotzsche PC, et al. Better reporting of
harms in randomized trials: an extension of the CONSORT
statement. Ann Intern Med 2004; 141: 781–88.22 Campbell MK, Elbourne DR, Altman DG. CONSORT statement:
extension to cluster randomid trials. BMJ 2004; 328: 702–08.
引咎辞职23 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: 1152–60. 24 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: 364–67.
25 Ioannidis JP, Gwinn M, Little J, et al. A road map for effi cient and
reliable human genome epidemiology. Nat Genet 2006; 38: 3–5.
26 Ormerod AD. CONSORT your submissions: an update for authors.
Br J Dermatol 2001; 145: 378–79.
27 Schriger DL. Suggestions for improving the reporting of clinical
rearch: the role of narrative. Ann Emerg Med 2005; 45: 437–43.
28 Sanderson S, Tatt ID, Higgins JP. Tools for asssing quality and
susceptibility to bias in obrvational studies in epidemiology: a
systematic review and annotated bibliography. Int J Epidemiol 2007;
36: 666–76.
29 Bartlett C, Sterne J, Egger M. What is newsworthy? Longitudinal
study of the reporting of medical rearch in two British
newspapers. BMJ 2002; 325: 81–84.
© 2007 The Authors
