Reporting standards for studies of diagnostic test accuracy in dementia: The STARDdem Initiative.
Noel-Storr AH., McCleery JM., Richard E., Ritchie CW., Flicker L., Cullum SJ., Davis D., Quinn TJ., Hyde C., Rutjes AW., Smailagic N., Marcus S., Black S., Blennow K., Brayne C., Fiorivanti M., Johnson JK., Köpke S., Schneider LS., Simmons A., Mattsson N., Zetterberg H., Bossuyt PM., Wilcock G., McShane R.
OBJECTIVE: To provide guidance on standards for reporting studies of diagnostic test accuracy for dementia disorders. METHODS: An international consensus process on reporting standards in dementia and cognitive impairment (STARDdem) was established, focusing on studies presenting data from which sensitivity and specificity were reported or could be derived. A working group led the initiative through 4 rounds of consensus work, using a modified Delphi process and culminating in a face-to-face consensus meeting in October 2012. The aim of this process was to agree on how best to supplement the generic standards of the STARD statement to enhance their utility and encourage their use in dementia research. RESULTS: More than 200 comments were received during the wider consultation rounds. The areas at most risk of inadequate reporting were identified and a set of dementia-specific recommendations to supplement the STARD guidance were developed, including better reporting of patient selection, the reference standard used, avoidance of circularity, and reporting of test-retest reliability. CONCLUSION: STARDdem is an implementation of the STARD statement in which the original checklist is elaborated and supplemented with guidance pertinent to studies of cognitive disorders. Its adoption is expected to increase transparency, enable more effective evaluation of diagnostic tests in Alzheimer disease and dementia, contribute to greater adherence to methodologic standards, and advance the development of Alzheimer biomarkers.