STARD for registration: establishing guidance on where and how to register diagnostic accuracy studies prospectively

ID: 

117

Session: 

Poster session 1

Date: 

Monday 24 October 2016 - 10:30 to 11:00

Location: 

All authors in correct order:

Korevaar D1, Cohen J1, Askie L2, Faure H3, Gatsonis C4, Hunter K2, Kressel H5, McInnes M6, Moher D7, Rifai N8, Hooft L9, Bossuyt P1
1 Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, University of Amsterdam, The Netherlands
2 Australian New Zealand Clinical Trials Registry (ANZCTR), NHMRC Clinical Trials Centre, University of Sydney, Australia
3 ISRCTN registry, BioMed Central, London, UK
4 Department of Biostatistics, Brown University School of Public Health, Providence, USA
5 Professor of Radiology Harvard Medical school, Radiology Editorial Office, Boston, USA
6 Department of Radiology, University of Ottawa, Canada
7 Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada
8 Clinical Chemistry Editorial Office, Washington, USA
9 The Netherlands Trial Register and Cochrane The Netherlands, Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, University Utrecht, The Netherlands
Presenting author and contact person

Presenting author:

Daniël Korevaar

Contact person:

Abstract text
Background: The advantages of prospective registration are multiple, and include the identification of unpublished studies. Many diagnostic accuracy studies remain unpublished, but so far these studies are rarely registered. This could be caused by the existing guidance for registering trials, which mainly focuses on comparative trials of therapeutic interventions or systematic reviews.

Objectives: To develop guidance on where and how to register diagnostic accuracy studies, thereby facilitating and encouraging informative registration.

Methods: Two surveys were developed based on multiple-choice questions, each with the option for further clarification in an open comment box. In survey 1, a representative of each Primary Registry in the World Health Organization’s Registry Network (n = 15) and of ClinicalTrials.gov were invited to comment on their registry’s policy for registering diagnostic accuracy studies. In survey 2, the STARD group members (STAndards for Reporting Diagnostic accuracy; n = 85) were invited to indicate whether or not 20 proposed protocol elements that specifically apply to diagnostic accuracy studies should be included in the registry record. A majority vote was defined as ≥ 2/3 agreement.

Results: In survey 1, still open at the time of writing, 10/16 (63%) invitees replied; eight agreed that registration of diagnostic accuracy studies in existing trial registries is preferred over developing a registry specifically designed for these studies; five registries always accept registration of these studies, whereas five do so in some cases; one registry already provided guidance for registering these studies while eight would be willing to consider implementing a guidance document for registering these studies. In survey 2, 71/85 (84%) invitees responded. A majority vote was reached for 14 of the 20 proposed protocol elements but additional elements were also proposed.

Conclusions: Many trial registries accept registration of diagnostic accuracy studies. The collected responses will help the development of a guidance document for registering such studies.