The potential for genome-wide association studies to relate phenotypes to specific genetic variation is greatly increased when data can be combined or compared across multiple studies. To facilitate replication and validation across studies, RTI International (Research Triangle Park, North Carolina) and the National Human Genome Research Institute (Bethesda, Maryland) are collaborating on the consensus measures for Phenotypes and eXposures (PhenX) project. The goal of PhenX is to identify 15 high-priority, well-established, and broadly applicable measures for each of 21 research domains. PhenX measures are selected by working groups of domain experts using a consensus process that includes input from the scientific community. The selected measures are then made freely available to the scientific community via the PhenX Toolkit. Thus, the PhenX Toolkit provides the research community with a core set of high-quality, well-established, low-burden measures intended for use in large-scale genomic studies. PhenX measures will have the most impact when included at the experimental design stage. The PhenX Toolkit also includes links to standards and resources in an effort to facilitate data harmonization to legacy data. Broad acceptance and use of PhenX measures will promote cross-study comparisons to increase statistical power for identifying and replicating variants associated with complex diseases and with gene-gene and gene-environment interactions.

The need for comprehensive analysis to compare and combine data across multiple studies in order to validate and extend results is widely recognized. This paper aims to assess the extent of data compatibility in the substance abuse and addiction (SAA) sciences through an examination of measure commonality, defined as the use of similar measures, across grants funded by the National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA). Data were extracted from applications of funded, active grants involving human-subjects research in four scientific areas (epidemiology, prevention, services, and treatment) and six frequently assessed scientific domains. A total of 548 distinct measures were cited across 141 randomly sampled applications. Commonality, as assessed by density (range of 0–1) of shared measurement, was examined. Results showed that commonality was low and varied by domain/area. Commonality was most prominent for (1) diagnostic interviews (structured and semi-structured) for substance use disorders and psychopathology (density of 0.88), followed by (2) scales to assess dimensions of substance use problems and disorders (0.70), (3) scales to assess dimensions of affect and psychopathology (0.69), (4) measures of substance use quantity and frequency (0.62), (5) measures of personality traits (0.40), and (6) assessments of cognitive/neurologic ability (0.22). The areas of prevention (density of 0.41) and treatment (0.42) had greater commonality than epidemiology (0.36) and services (0.32). To address the lack of measure commonality, NIDA and its scientific partners recommend and provide common measures for SAA researchers within the PhenX Toolkit.

The PhenX (consensus measures for Phenotypes and eXposures) Toolkit offers well-established, broadly validated measures of phenotypes and exposures relevant to investigators in human genomics, epidemiology, and biomedical research. This methods report describes the infrastructure and processes used to develop the content and features of the Toolkit. The PhenX consensus process is robust, yet flexible, as evidenced by its application to a range of research domains. During the initial phase of PhenX, from March 2008 through April 2010, working groups of content experts addressed 21 research domains and selected 295 measures for the Toolkit. The PhenX Steering Committee prioritized and defined the scope of the domains and guided the consensus process with input from liaisons representing the National Institutes of Health. After the 21 domains were completed, another project to add breadth and depth to the Toolkit for substance abuse and addiction (SAA) research served to validate the consensus process. With the support of the SAA Scientific Panel to define the scope for one core and six specialty collections and SAA working groups to select measures, the PhenX project team added 44 measures to the Toolkit in 2012. Now being used by more than 1,000 researchers, the PhenX Toolkit offers a catalog of measures, supporting documentation, and tools for collaborative research. It used a consensus process that can serve as a template for investigators who are considering a similar approach. Contents

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Both biological and behavioral data will be obtained at baseline and 12 and 24 months post-baseline. Communities that receive the intervention will be compared with matched control communities on two primary outcomes: (i) a change in self-reported unprotected sexual acts with non-spousal, non-live-in partners; and (ii) the incidence of sexually transmitted disease (STD), defined as a composite index of viral and bacterial STD.