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STARD Initiative |
1 Department of Clinical Epidemiology and Biostatistics, Academic Medical Center—University of Amsterdam, 1100 DE Amsterdam, The Netherlands.
2 Department of Pathology, University of Virginia, Charlottesville, VA 22903.
3 Clinical Chemistry, Washington, DC 20037.
4 Centre for Statistical Sciences, Brown University, Providence, RI 02912.
5 Centre for General Practice, University of Queensland, Herston QLD 4006, Australia.
6 Department of Public Health & Community Medicine, University of Sydney, Sydney NSW 2006, Australia.
7 Chalmers Research Group, Ottowa, Ontario, K1N 6M4 Canada.
8 Institute for Health Policy Studies, University of California, San Francisco, San Francisco, CA 94118.
9 Journal of the American Medical Association, Chicago, IL 60610.
10 Institute for Research in Extramural Medicine, Free University, 1081 BT Amsterdam, The Netherlands.
aAddress correspondence to this author at: Department of Clinical Epidemiology and Biostatistics, Academic Medical Center—University of Amsterdam, PO Box 22700, 1100 DE Amsterdam, The Netherlands. Fax 31-20-6912683; e-mail Stard{at}amc.uva.nl.
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Abstract |
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 Top Abstract IntroductionMaterials and MethodsResultsDiscussionAppendix 1References |
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Objective: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy to allow readers to assess the potential for bias in the study and to evaluate its generalisability.
Methods: The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee 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 on diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. The consensus meeting shortened the list to 25 items, using evidence on bias 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 clinicians, researchers, reviewers, journals, and the public.
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Introduction |
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TopAbstractIntroductionMaterials and MethodsResultsDiscussionAppendix 1References |
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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 as further 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)(5)(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 metaanalyses (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 substandard 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)(12)(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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Materials and Methods |
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TopAbstractIntroductionMaterials and MethodsResultsDiscussionAppendix 1References |
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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 committee discussed all comments and assembled the final checklist.
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Results |
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TopAbstractIntroductionMaterials and MethodsResultsDiscussionAppendix 1References |
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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 Table 1
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The flow diagram provides information about the method of patient recruitment (e.g., based on a consecutive series of patients with specific symptoms, case-control), the order of test execution, and the number of patients undergoing the test under evaluation (index test) and the reference test (see Fig. 1
). We provide one prototypical flowchart that reflects the most commonly employed design in diagnostic research. Examples that reflect other designs are on the STARD Web site (seewww.consort-statement.org.htm)
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Discussion |
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TopAbstractIntroductionMaterials and MethodsResultsDiscussionAppendix 1References |
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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; Refs. (17)(18)(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 1 |
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TopAbstractIntroductionMaterials and MethodsResultsDiscussionAppendix 1References |
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Members of the STARD group
Doug Altman, Institute of Health Sciences, Centre for Statistics in Medicine (Oxford, United Kingdom); Stuart Barton, British Medical Journal, BMA House (London, United Kingdom); Colin Begg, Memorial Sloan-Kettering Cancer Center, Department Epidemiology & Biostatistics (New York, NY); William Black, Dartmouth Hitchcock Medical Center, Department of Radiology (Lebanon, NH); Harry Büller, Academic Medical Center, Department of Vascular Medicine (Amsterdam, The Netherlands); Gregory Campbell, US FDA, Center for Devices and Radiological Health (Rockville, MD); Frank Davidoff, Annals of Internal Medicine (Philadelphia, PA); Jon Deeks, Institute of Health Sciences, Centre for Statistics in Medicine (Old Road, United Kingdom); Paul Dieppe, Department Social Medicine, University of Bristol (Bristol, United Kingdom); Kenneth Fleming, John Radcliffe Hospital, (Oxford, United Kingdom); Rijk van Ginkel, Academic Medical Center, Department of Clinical Epidemiology (Amsterdam, The Netherlands); Afina Glas, Academic Medical Center, Department of Clinical Epidemiology (Amsterdam, The Netherlands); Gordon Guyatt, McMaster University, Clinical Epidemiology and Biostatistics (Hamilton, Canada); James Hanley, McGill University, Department Epidemiology & Biostatistics (Montreal, Canada); Richard Horton, The Lancet, (London, United Kingdom); Myriam Hunink, Erasmus Medical Center, Department of Epidemiology & Biostatistics (Rotterdam, The Netherlands); Jos Kleijnen, NHS Centre for Reviews and Dissemination (York, United Kingdom); Andre Knottnerus, Maastricht University, Netherlands School of Primary Care Research (Maastricht, The Netherlands); Erik Magid, Amager Hospital, Department of Clinical Biochemistry (Copenhagen, Denmark); Barbara McNeil, Harvard Medical School, Department of Health Care Policy (Boston, MA); Matthew McQueen, Hamilton Civic Hospitals, Department of Laboratory Medicine (Hamilton, Canada); Andrew Onderdonk, Channing Laboratory (Boston, MA); John Overbeke, Nederlands Tijdschrift voor Geneeskunde (Amsterdam, The Netherlands); Christopher Price, St Bartholomew’s - Royal London School of Medicine and Dentistry (London, United Kingdom); Anthony Proto, Radiology Editorial Office (Richmond, VA);Hans Reitsma, Academic Medical Center, Department of Clinical Epidemiology (Amsterdam, The Netherlands); David Sackett, Trout Centre (Ontario, Canada); Gerard Sanders, Academic Medical Center, Department of Clinical Chemistry (Amsterdam, The Netherlands); Harold Sox, Annals of Internal Medicine (Philadelphia, PA); Sharon Straus, Mt. Sinai Hospital (Toronto, Canada); Stephan Walter, McMaster University, Clinical Epidemiology and Biostatistics (Hamilton, Canada).
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Acknowledgments |
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References |
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A. Clerico and M. Emdin Diagnostic Accuracy and Prognostic Relevance of the Measurement of Cardiac Natriuretic Peptides: A Review Clin. Chem., January 1, 2004; 50(1): 33 - 50. [Abstract] [Full Text] [PDF]
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 M.-L. He, B. Zheng, Y. Peng, J. S. M. Peiris, L. L. M. Poon, K. Y. Yuen, M. C. M. Lin, H.-f. Kung, and Y. Guan Inhibition of SARS-Associated Coronavirus Infection and Replication by RNA Interference JAMA, November 26, 2003; 290(20): 2665 - 2666. [Full Text] [PDF]
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V. M. Montori and G. H. Guyatt Summarizing Studies of Diagnostic Test Performance Clin. Chem., November 1, 2003; 49(11): 1783 - 1784. [Full Text] [PDF]
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J. G. Elmore, C. Y. Nakano, T. D. Koepsell, L. M. Desnick, C. J. D'Orsi, and D. F. Ransohoff International Variation in Screening Mammography Interpretations in Community-Based Programs J Natl Cancer Inst, September 17, 2003; 95(18): 1384 - 1393. [Abstract] [Full Text] [PDF]
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D. A. Herold and R. L. Fitzgerald Immunoassays for Testosterone in Women: Better than a Guess? Clin. Chem., August 1, 2003; 49(8): 1250 - 1251. [Full Text] [PDF]
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A. Carroccio, G. Iacono, M. Cottone, L. Di Prima, F. Cartabellotta, F. Cavataio, C. Scalici, G. Montalto, G. Di Fede, G. Rini, et al. Diagnostic Accuracy of Fecal Calprotectin Assay in Distinguishing Organic Causes of Chronic Diarrhea from Irritable Bowel Syndrome: A Prospective Study in Adults and Children Clin. Chem., June 1, 2003; 49(6): 861 - 867. [Abstract] [Full Text] [PDF]
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D. Rennie Improving Reports of Studies of Diagnostic Tests: The STARD Initiative JAMA, January 1, 2003; 289(1): 89 - 90. [Full Text] [PDF]
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P. M. Bossuyt, J. B. Reitsma, D. E. Bruns, C. A. Gatsonis, P. P. Glasziou, L. M. Irwig, D. Moher, D. Rennie, H. C.W. de Vet, and J. G. Lijmer The STARD Statement for Reporting Studies of Diagnostic Accuracy: Explanation and Elaboration Clin. Chem., January 1, 2003; 49(1): 7 - 18. [Abstract] [Full Text] [PDF]
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D. E. Bruns The STARD Initiative and the Reporting of Studies of Diagnostic Accuracy Clin. Chem., January 1, 2003; 49(1): 19 - 20. [Full Text] [PDF]
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