Concept Clearance - First-Generation RDoC Standard Data Elements
NAMHC Concept Clearance:
Bruce Cuthbert, Ph.D.
Division of Adult Translational Research and Treatment Development
This initiative aims to develop and implement an operational template for including standard data elements in Research Domain Criteria (RDoC)-themed research, and produce an initial set of recommended, provisional standard data elements.
The RDoC Project is an implementation of Strategy 1.4 of the NIMH Strategic Plan: “Develop, for research purposes, new ways of classifying mental disorders based on dimensions of observable behavior and neurobiological measures.” The aim of RDoC is to support research grants that study patients in terms of fundamental behavioral-neural systems (for instance, fear or working memory) rather than traditional diagnostic categories; the long-term goal is to develop a research literature that can inform future neuroscience-based diagnostic systems for mental disorders. To generate a systematic RDoC database for this purpose, it is important to develop a procedure for determining common data standards across studies and to specify a set of paradigms and measures that are generally accepted by the field. However, if we prematurely establish standards for non-optimal affective/behavioral/cognitive tasks, we run the risk of hampering future revisions of constructs, leading to deleterious effects on the long-term development of RDoC. A reasonable compromise would be to establish general data formats, and to begin development of a program for standardized paradigms and measures. The latter would be explicitly intended to be revised every 3-4 years, in order to incorporate new developments and findings, while still offering the field some standardization that can foster building databases. Ideally, we would have 2-4 paradigms and/or measures that are available for each RDoC construct in order to provide researchers a choice among a group of vetted elements, while still maintaining a degree of standardization. Use of such paradigms/measures would be strongly encouraged and a component of review criteria, but not required. Studies to develop new/revised RDoC constructs would still be fully acceptable, and only the basic aspects of the common data elements (e.g., age, family history) would be stipulated. In addition, as an integral part of the RDoC scientific agenda, NIMH would encourage researchers to include additional new paradigms/measures that are intended to improve upon, and thus supersede, the current paradigms/measures.
This initiative would accomplish the following goals:
- Establish a working group of experts in various fields who can advise on tasks and measures in all RDoC domains. Such tasks would include paradigms both for children of various age ranges, and for adults; priority would be given to paradigms where the same basic task can be used (with appropriate parametric variations) across a range of children and adults.
- Survey the current status of paradigm and measurement development to determine recommended elements for all RDoC domains and constructs.
- Determine standards for databases (e.g., formatting), following current standards such as the National Institute of Neurological Disorders and Stroke (NINDS)-supported Common Data Elements platform.
- Evaluate the development of a platform for developing and distributing RDoC laboratory paradigms, using a standard experimental platform to be determined.
- Where available, implement well-validated tasks and measures into a common system.
- Identify where no or insufficient measures are available, either for developmental or adult populations.
- Devise a procedure for revising the data elements on a periodic basis (every two to three years), revising or replacing tasks and measures as appropriate on the basis of new findings in the literature.