The STARD Statement for Reporting Studies of Diagnostic Accuracy: Explanation and Elaboration

Abstract

The quality of reporting of studies of diagnostic accuracy is less than optimal. Complete and accurate reporting is necessary to enable readers to assess the potential for bias in the study and to evaluate the generalisability of the results.A group of scientists and editors has developed the STARD (Standards for Reporting of Diagnostic Accuracy) statement to improve the reporting the quality of reporting of studies of diagnostic accuracy. The statement consists of a checklist of 25 items and flow diagram that authors can use to ensure that all relevant information is present.This explanatory document aims to facilitate the use, understanding and dissemination of the checklist. The document contains a clarification of the meaning, rationale and optimal use of each item on the checklist, as well as a short summary of the available evidence on bias and applicability.The STARD statement, checklist, flowchart and this explanation and elaboration document should be useful resources to improve reporting of diagnostic accuracy studies. Complete and informative reporting can only lead to better decisions in healthcare.

Molecular Markers for Bladder Cancer Screening, Early Diagnosis, and Surveillance: The WHO/ICUD Consensus

“…As described by Glas et al [40], the quality of the literature is weak and we concur based on our evaluation using the STARD checklist [27]. No study met all 25 STARD items.…”

“…As for other markers discussed in this assessment, quality of reporting according to the STARD criteria is moderate to poor, in part due to the fact that the majority of trials were conducted earlier [26,27]. We conclude that the LoE of studies on NMP22 is LoE 3 and in some studies LoE 2b according to the Oxford classification [25].…”

“…In this assessment the different markers and trials were classified according to (1) the level of evidence (LoE) for diagnostic procedures (Oxford classification 2001/9) [25], (2) the accuracy of data reporting according to the STARD criteria [26,27], and (3) the status of the marker with regard to clinical implementation (IBCN classification) [8]. Finally, a consensus on four key questions was obtained prospectively: (1) ‘(How) can molecular markers support screening of patients at risk of having or developing bladder cancer?…”

“…Accuracy of reporting according to the STARD criteria [26,27] was mostly moderate or poor, with only a few papers displaying good reporting quality. Specifically, information on the training and experience of investigators - a parameter highly affecting uCyt™ results - was not provided, and information on the blinding of investigators towards clinical observations was rare.…”

“…These tools included a questionnaire for the quality of reporting (STARD), the definition of the LoE according to the Oxford criteria, and the classification of the marker status [8,25,26,27]. …”