Aim of STARD
The aim of the STARD initiative is 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 (internal validity) and to evaluate its generalisability (external validity).
The STARD statement consist of a
25 items and recommends the use of a
flow diagram which describe the design of
the study and the flow of patients.
The STARD statement (STARD initiative) is published several journals, including Radiology, Annals of Internal Medicine, BMJ, and Clinical Chemistry. A separate background document explaining the meaning and rationale of each item and briefly summarizing the available evidence is published in Annals of Internal Medicine and Clinical Chemistry.
History of STARD
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, 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 STARD steering committee started with an extensive search to identify publications on the conduct and reporting of diagnostic studies. This search included the MEDLINE, Embase, BIOSIS and the methodological database from the Cochrane Collaboration up to July 2000. In addition, the steering committee members examined reference lists of retrieved articles, search personal files, and contacted other experts in the field of diagnostic research. They reviewed all relevant publications and extracted an extended list of potential checklist items.
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 (STARD group). 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.
The search for published guidelines for diagnostic research yielded 33 checklists. Based on these published guidelines and on input of steering and STARD group members, the steering committee assembled a list of 75 items. During the consensus meeting on 16-17 September 2000, participants consolidated and eliminated items to form the 25-item checklist. Conference members made major revisions to the phrasing and format of the checklist.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