Article type
Year
Abstract
Background: The advantages of prospective registration are multiple, and include the identification of unpublished studies. Many diagnostic accuracy studies remain unpublished, but so far these studies are rarely registered.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.
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.