Do we need a checklist for reporting the results of diagnostic test evaluations? The STARD proposal.

The STARD (Standards for Reporting of Diagnostic Accuracy) checklist and supporting document appeared earlier this year in a number of medical journals and is reprinted in this issue for the benefit of the readership of Academic Radiology. This is the first comprehensive effort of its kind in our field; it is international and multidisciplinary, encompassing researchers from several countries and from several scientific and clinical disciplines involved in the development, evaluation, and clinical use of diagnostic tests. Importantly, the initiative also includes editors of leading journals that publish studies of diagnostic tests. The STARD document describes the process by which the checklist was developed and summarizes the rationale for the inclusion of specific items in the list. These issues are discussed in detail in a longer technical document that also was published earlier this year (1). Like that of similar initiatives in other areas of medicine, the purpose of STARD is twofold. The short-term objective is to provide and disseminate a set of guidelines for use by authors, journal editors, and readers of studies evaluating the performance of diagnostic and screening tests. Broad dissemination and adoption of the checklist will make it possible for the STARD initiative to achieve its long-term objective, which is to enhance the accuracy and completeness of reporting and to help improve the overall quality of studies in diagnostic test evaluation. The STARD initiative is broad in the sense that it covers the evaluation of diagnostic tests in general, including diagnostic imaging and laboratory tests. However, the initiative is also focused in the sense that it addresses only the reporting of studies of the diagnostic accuracy of tests and not the reporting of studies of other aspects of test performance, such as effects on intermediate, processof-care outcomes or on long-term, patient-level outcomes (2,3). Other sets of guidelines, such as those developed by the Consolidated Standards of Reporting Trials (CONSORT) initiative for the reporting of results of randomized clinical trials, may be applied to studies of process-of-care and patient-level outcomes (4). The STARD checklist contains items that are relevant across the spectrum of diagnostic tests. It also places clear emphasis on the elements of a study that have the greatest bearing on the study’s validity and generalizability. In particular, the checklist emphasizes the importance of accurate description of the study context and the study participants— both the subjects and the interpreters. These are key data for any subsequent discussion of the applicability of study results. Additional factors may have to be considered in tailoring the checklist for particular classes of diagnostic tests. In the case of diagnostic imaging modalities, the relative weight and content of specific items on the checklist may differ according to the stage in the technology evaluation process at which a study was conducted. For example, the emphasis on the clinical context or on variability across interpreters will likely be different between stage I studies aiming at the establishment of technical parameters and diagnostic criteria for a new modality and stage III, multicenter studies aiming at the evaluation of mature diagnostic modalities. Acad Radiol 2003; 10:599–600