The STARD statement – STAndards for Reporting Diagnostic Accuracy
Diagnostic tests are continuously evolving with a rapid development in new tests as well as improvements in the existing ones. Studies on the evaluation of existing or novel diagnostic tests are critically important as they facilitate informed decision making on the utility of a test in medical practice to the microbiologists, clinicians and laboratory. However, a significant number of the submitted diagnostic tests’ manuscripts are rejected during the journal peer-review process either due to poor study quality (flaws in the design and process of the study) or poor study reporting (inadequate/incomplete reporting of study design, methodology, statistical analysis and results).
Poor reporting is a major concern for the diagnostic studies according to vast literature and reviews. The poorly reported diagnostic test studies may lead to incorrect treatment decisions among the physicians. Majority of the studies of diagnostic accuracy published in major medical journals have mediocre methodology adopted; however, assessments are hampered due to the lack of information on key elements of the study design, process and analysis, which may lead to biased results, and thus the accuracy and integrity of diagnostic test becomes questionable.
In order to reduce the unwanted clinical consequences and the healthcare cost burden of unnecessary tests due to misleading information in ill-reported diagnostic test manuscripts, a rigorous peer-review evaluation process to determine the diagnostic accuracy of a test is required prior to its introduction into clinical practice.
The low methodological quality and substandard reporting of diagnostic test evaluations were discussed by the Cochrane Diagnostic and Screening Test Methods Working Group at the 1999 Cochrane Colloquium meeting in Rome. According to the group, improvement in the quality of reporting of the diagnostic studies was considered as the first step to counter these problems. Hence, following the success of CONSORT (consolidated standards of reporting trials) initiative, a checklist of items was aimed to be developed for the report of diagnostic test studies by the Working Group. Complete and accurate reporting allows the reader to detect the potential for bias in the study (internal validity) and to assess the generalizability and applicability of the results (external validity)
To achieve the transparency and completeness of reporting of diagnostic accuracy studies, the STARD statement (Standards for Reporting Diagnostic Accuracy) was published in 2003. The STARD statement provides a 25-item checklist and a flow diagram that are required to be addressed when reporting diagnostic accuracy studies.
Many journals are encouraging the authors to follow the STARD guidelines, checklist and flow diagram in their submissions of diagnostic accuracy manuscripts. Following of these guidelines are likely to facilitate the manuscript peer review process, increased manuscript acceptance rates, and ultimately the improvement in the clinical impact of the articles.