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Special Reports |
1 From the Department of Clinical Epidemiology and Biostatistics, Academic Medical Center, University of Amsterdam, PO Box 22700, 1100 DE Amsterdam, the Netherlands (P.M.B., J.B.R. J.G.L.); Department of Clinical Chemistry, University of Virginia Health System, Charlottesville (D.E.B.); Center for Statistical Sciences, Brown University, Providence, RI (C.A.G.); Department of Social and Preventive Medicine, Mayne Medical School, Herston, Australia (P.P.G.); Department of Public Health and Community Medicine, University of Sydney, Australia (L.M.I.); Chalmers Research Group, Ottawa, Ontario, Canada (D.M.); Institute for Health Policy Studies, UCSF School of Medicine, San Francisco, Calif, and Journal of the American Medical Association, Chicago, Ill (D.R.); and Institute for Research in Extramural Medicine, Free University, Amsterdam, the Netherlands (H.C.W.d.V.). Received and accepted October 8, 2002. Financial support to convene the STARD Group was provided in part by Dutch Health Care Insurance Board, International Federation of Clinical Chemistry, Medical Research Council’s Health Services Research Collaboration, and Academic Medical Center in Amsterdam. Address correspondence to P.M.B. and J.B.R. (e-mail: stard@amc.uva.nl).
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONMETHODSRESULTSDISCUSSIONAPPENDIXREFERENCES |
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METHODS: The Standards for Reporting of Diagnostic Accuracy (STARD) steering group searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organisations shortened this list during a two-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy.
RESULTS: The search for published guidelines regarding diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. At the consensus meeting, participants shortened the list to a 25-item checklist, using evidence, whenever available. A prototypical flow diagram provides information about the method of patient recruitment, the order of test execution and the numbers of patients undergoing the test under evaluation, the reference standard or both.
CONCLUSIONS: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of the clinicians, researchers, reviewers, journals, and the public.
© RSNA, 2003
Index terms: Radiology and radiologists, research • Special Reports
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONAPPENDIXREFERENCES |
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The world of diagnostic tests is highly dynamic. New tests are developed at a fast rate and the technology of existing tests is continuously being improved. Exaggerated and biased results from poorly designed and reported diagnostic studies can trigger their premature dissemination and lead physicians into making incorrect treatment decisions. A rigorous evaluation process of diagnostic tests before introduction into clinical practice could not only reduce the number of unwanted clinical consequences related to misleading estimates of test accuracy, but also limit health care costs by preventing unnecessary testing. Studies to determine the diagnostic accuracy of a test are a vital part in this evaluation process (1–3).
In studies of diagnostic accuracy, the outcomes from one or more tests under evaluation are compared with outcomes from the reference standard, both measured in subjects who are suspected of having the condition of interest. The term test refers to any method for obtaining additional information on a patient’s health status. It includes information from history and physical examination, laboratory tests, imaging tests, function tests and histopathology. The condition of interest or target condition can refer to a particular disease or to any other identifiable condition that may prompt clinical actions, such asfurther diagnostic testing, or the initiation, modification or termination of treatment. In this framework, the reference standard is considered to be the best available method for establishing the presence or absence of the condition of interest. The reference standard can be a single method, or a combination of methods, to establish the presence of the target condition. It can include laboratory tests, imaging tests, pathology, but also dedicated clinical follow-up of subjects. The term accuracy refers to the amount of agreement between the information from the test under evaluation, referred to as the index test, and the reference standard. Diagnostic accuracy can be expressed in many ways, including sensitivity and specificity, likelihood ratios, diagnostic odds ratio, and the area under a receiver operator characteristic (ROC) curve (4–6).
There are several potential threats to the internal and external validity of a study of diagnostic accuracy. A survey of studies of diagnostic accuracy published in four major medical journals between 1978 and 1993 revealed that the methodological quality was mediocre at best (7). However, evaluations were hampered because many reports lacked information on key elements of design, conduct and analysis of diagnostic studies (7). The absence of critical information about the design and conduct of diagnostic studies has been confirmed by authors of meta-analyses (8,9). As in any other type of research, flaws in study design can lead to biased results. One report showed that diagnostic studies with specific design features are associated with biased, optimistic, estimates of diagnostic accuracy compared to studies without such deficiencies (10).
At the 1999 Cochrane Colloquium meeting in Rome, the Cochrane Diagnostic and Screening Test Methods Working Group discussed the low methodological quality and sub-standard reporting of diagnostic test evaluations. The Working Group felt that the first step to correct these problems was to improve the quality of reporting of diagnostic studies. Following the successful CONSORT initiative (11–13), the Working Group aimed at the development of a checklist of items that should be included in the report of a study of diagnostic accuracy.
The objective of the Standards for Reporting of Diagnostic Accuracy (STARD) initiative is to improve the quality of reporting of studies of diagnostic accuracy. Complete and accurate reporting allows the reader to detect the potential for bias in the study (internal validity) and to assess the generalisability and applicability of the results (external validity).
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METHODS |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONAPPENDIXREFERENCES |
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Subsequently, the STARD steering committee convened a two-day consensus meeting for invited experts from the following interest groups: researchers, editors, methodologists and professional organisations. The aim of the conference was to reduce the extended list of potential items, where appropriate, and to discuss the optimal format and phrasing of the checklist. The selection of items to retain was based on evidence whenever possible.
The meeting format consisted of a mixture of small group sessions and plenary sessions. Each small group focused on a group of related items of the list. The suggestions of the small groups were then discussed in plenary sessions. Overnight a first draft of the STARD checklist was assembled based on the suggestions from the small group and the additional remarks from the plenary sessions. All meeting attendees discussed this version the next day and made additional changes. The members of the STARD group could suggest further changes through a later round of comments by electronic mail.
Potential users field-tested the conference version of the checklist and flow diagram and additional comments were collected. This version was placed on the CONSORT Website with a call for comments. The STARD steering group discussed all comments and assembled the final checklist.
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RESULTS |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONAPPENDIXREFERENCES |
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The STARD group received valuable comments and remarks during the various stages of evaluation after the conference, which resulted in the version of the STARD checklist that appears in Figure 1.
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONAPPENDIXREFERENCES |
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We arranged the items under the usual headings of a medical research article but this is not intended to dictate the order in which they have to appear within an article.
The guiding principle in the development of the STARD checklist was to select items that would help readers to judge the potential for bias in the study and to appraise the applicability of the findings. Two other general considerations shaped the content and format of the checklist. First, the STARD group believes that one general checklist for studies of diagnostic accuracy, rather than different checklists for each field, is likely to be more widely disseminated and perhaps accepted by authors, peer reviewers, and journal editors. Although the evaluation of imaging tests differs from that of tests in the laboratory, we felt that these differences were more of degree than of kind. The second consideration was the development of a checklist specifically aimed at studies of diagnostic accuracy. We did not include general issues in the reporting of research findings, like the recommendations contained in the Uniform Requirements for Manuscripts submitted to Biomedical Journals (14).
Wherever possible, the STARD group based the decision to include an item on evidence linking the item to biased estimates (internal validity) or to variation in measures of diagnostic accuracy (external validity). The evidence varied from narrative articles explaining theoretical principles and papers presenting results from statistical modelling to empirical evidence derived from diagnostic studies. For several items, the evidence is rather limited.
A separate background document explains the meaning and rationale of each item and briefly summarises the type and amount of evidence (15). This background document should enhance the use, understanding and dissemination of the STARD checklist.
The STARD group put considerable effort into the development of a flow diagram for diagnostic studies. A flow diagram has the potential to communicate vital information about the design of a study and the flow of participants in a transparent manner (16). A comparable flow diagram has become an essential element in the CONSORT standards for reporting of randomized trials. The flow diagram could be even more essential in diagnostic studies, given the variety of designs employed in diagnostic research. Flow diagrams in the reports of diagnostic accuracy studies indicate the process of sampling and selecting participants (external validity), the flow of participants in relation to the timing and outcomes of tests, the number of subjects who fail to receive either the index test and/or the reference standard (potential for verification bias (17–19), and the number of patients at each stage of the study, thus providing the correct denominator for proportions (internal consistency).
The STARD group plans to measure the impact of the statement on the quality of published reports on diagnostic accuracy using a before-and-after evaluation (13). Updates of STARD will be provided when new evidence on sources of bias or variability becomes available. We welcome any comments, whether on content or form, to improve the current version.
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APPENDIX |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONAPPENDIXREFERENCES |
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Patrick Bossuyt, David Bruns, Constantine Gatsonis, Paul Glasziou, Les Irwig, Jeroen Lijmer, David Moher, Drummond Rennie, Riekie de Vet
Members of the STARD Group:
Doug Altman, Centre for Statistics in Medicine, Institute of Health Sciences, Oxford, United Kingdom; Stuart Barton, British Medical Journal, BMA House, London, United Kingdom; Colin Begg, Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY; William Black, Department of Radiology, Dartmouth Hitchcock Medical Center; Harry Büller, Department of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands; Gregory Campbell, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Rockville, Md; Frank Davidoff, Annals of Internal Medicine, Philadelphia, Pa; Jon Deeks, Centre for Statistics in Medicine, Institute of Health Sciences, Old Road, United Kingdom; Paul Dieppe, Department of Social Medicine, University of Bristol, United Kingdom; Kenneth Fleming, John Radcliffe Hospital, Oxford, United Kingdom; Rijk van Ginkel, Deptartment of Clinical Epidemiology and Biostatistics, Academic Medical Center, Amsterdam, the Netherlands; Afina Glas, Department of Clinical Epidemiology and Biostatistics, Academic Medical Center, Amsterdam, the Netherlands; Gordon Guyatt, Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada; James Hanley, Department of Epidemiology and Biostatistics, McGill University, Montreal, Quebec, Canada; Richard Horton, The Lancet, London, United Kingdom; Myriam Hunink, Department of Epidemiology and Biostatistics, Erasmus Medical Center, Rotterdam, the Netherlands; Jos Kleijnen, NHS Centre for Reviews and Dissemination, York, United Kingdom; Andre Knottnerus, Netherlands School of Primary Care Research, Maastricht University; Erik Magid, Department of Clinical Biochemistry, Amager Hospital, Copenhagen, Denmark; Barbara McNeil, Department of Health Care Policy, Harvard Medical School, Boston, Mass; Matthew McQueen, Department of Laboratory Medicine, Hamilton Civic Hospitals, Ontario, Canada; Andrew Onderdonk, Channing Laboratory, Boston, Mass; John Overbeke, Nederlands Tijdschrift voor Geneeskunde, Amsterdam; Christopher Price, St Bartholemew’s–Royal London School of Medicine and Dentistry, United Kingdom; Anthony V. Proto, Radiology Editorial Office, Richmond, Va; Hans Reitsma, Department of Clinical Epidemiology and Biostatistics, Academic Medical Center, Amsterdam, the Netherlands; David Sackett, Trout Centre, Ontario, Canada; Gerard Sanders, Department of Clinical Chemistry, Academic Medical Center, Amsterdam, the Netherlands; Harold Sox, Annals of Internal Medicine, Philadelphia, Pa; Sharon Straus, Mt Sinai Hospital, Toronto, Ontario, Canada; Stephan Walter, Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
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ACKNOWLEDGMENTS |
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FOOTNOTES |
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See also the From the Editor article in this issue.
Abbreviation: STARD = Standards for Reporting of Diagnostic Accuracy
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONAPPENDIXREFERENCES |
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