An initiative using informatics to facilitate clinical research planning and recruitment in the VA health care system.

BACKGROUND: Randomized clinical trials are the gold standard for evaluating healthcare interventions and, more generally, add to the medical knowledge related to the treatment, diagnosis and prevention of diseases and conditions. Recent literature continues to identify health informatics methods that can help improve study efficiency throughout the life cycle of a clinical trial. Electronic medical record (EMR) data provides a mechanism to facilitate clinical trial research during the study planning and execution phases, and ultimately, can be utilized to enhance recruitment. The Department of Veterans Affairs (VA) has a strong history of clinical and epidemiological research with over four decades of data collected from Veterans it has served nationwide. The VA Informatics and Computing Infrastructure (VINCI) provides VA research investigators with a nationwide view of high-value VA patient data. Within VA, the Cooperative Studies Program (CSP) Network of Dedicated Enrollment Sites (NODES) is a consortium of nine sites that are part of an embedded clinical research infrastructure intended to provide systematic site-level solutions to issues that arise during the conduct of VA CSP clinical research. This paper describes the collaboration initiated by the Salt Lake City (SLC) node site to bring informatics and clinical trials together to enhance study planning and recruitment within the VA. METHODS: The SLC VA Medical Center physically houses both VINCI and a node site and the co-location of these two groups prompted a natural collaboration on both a local and national level. One of the functions of the SLC NODES is to enhance recruitment and promote the success of CSP projects. VINCI supports these efforts by providing VA researchers access to potential population pools. VINCI can provide 1) feasibility data during study planning, and 2) active patient lists during recruitment. The process for CSP study teams to utilize these services involves regulatory documentation, development of queries, revisions to the initial data request, and ongoing communications with several key study personnel including the requesting research team, study statisticians, and VINCI data managers. RESULTS: The early efforts of SLC NODES and VINCI aimed to provide patient lists exclusively to the SLC CSP study teams for the following purposes: 1) increasing recruitment for trials that were struggling to meet their respective enrollment goals, and 2) decreasing the time required by study coordinators to complete chart review activities. This effort was expanded to include multiple CSP sites and studies. To date, SLC NODES has facilitated the delivery of these VINCI services to nine active CSP studies. CONCLUSION: The ability of clinical trial study teams to successfully plan and execute their respective trials is contingent upon their proficiency in obtaining data that will help them efficiently and effectively recruit and enroll eligible participants. This collaboration demonstrates that the utilization of a model that partners two distinct entities, with similar objectives, was effective in the provision of feasibility and patient lists to clinical trial study teams and facilitation of clinical trial research within a large, integrated healthcare system.

Relative Utility of Performance and Symptom Validity Tests.

This investigation adds to the burgeoning body of research concerned with discriminating performance and symptom validity tests (SVTs) through examination of their differential relationships with cognitive performance and symptom self-report measures. To the authors' current knowledge, prior studies have not assessed differences between participants who fail either a performance validity test (PVT) or an SVT but not both. As part of their neuropsychological evaluations at four Veterans Affairs medical centers across the United States, participants were administered a fixed, standardized battery that consisted of performance validity, symptom validity, cognitive performance, and symptom self-report measures. Compared with participants who failed a PVT and an SVT, participants who passed both and participants who only passed a PVT demonstrated better cognitive performance and self-reported fewer symptoms. Results support differential clinical utility of performance validity and SVTs when assessing cognitive performance and symptom self-report.

The dangers of failing one or more performance validity tests in individuals claiming mild traumatic brain injury-related postconcussive symptoms.

Evaluating performance validity is important in any neuropsychological assessment, and prior research recommends a threshold for invalid performance of two or more performance validity test (PVT) failures. However, extant findings also indicate that failing a single PVT is associated with significant changes in neuropsychological performance. The current study sought to determine if there is an appreciable difference in neuropsychological testing results between individuals failing different numbers of PVTs. In a sample of veterans with reported histories of mild traumatic brain injury (mTBI; N =178), analyses revealed that individuals failing only one PVT performed significantly worse than individuals failing no PVTs on measures of verbal learning and memory, processing speed, and cognitive flexibility. Additionally, individuals failing one versus two PVTs significantly differed only on delayed free recall scores. The current findings suggest that failure of even one PVT should elicit consideration of performance invalidity, particularly in individuals with histories of mTBI.

PTSD and cognitive functioning: importance of including performance validity testing.

Many studies have observed an association between post-traumatic stress disorder (PTSD) and cognitive deficits across several domains including memory, attention, and executive functioning. The inclusion of response bias measures in these studies, however, remains largely unaddressed. The purpose of this study was to identify possible cognitive impairments correlated with PTSD in returning OEF/OIF/OND veterans after excluding individuals failing a well-validated performance validity test. Participants included 126 men and 8 women with a history of mild traumatic brain injury (TBI) referred for a comprehensive neuropsychological evaluation as part of a consortium of five Veterans Affairs hospitals. The PTSD CheckList (PCL) and Word Memory Test (WMT) were used to establish symptoms of PTSD and invalid performance, respectively. Groups were categorized as follows: Control (PCL < 50, pass WMT), PTSD-pass (PCL ≥ 50, pass WMT), and PTSD-fail (PCL ≥ 50, fail WMT). As hypothesized, failure on the WMT was associated with significantly poorer performance on almost all cognitive tests administered; however, no significant differences were detected between individuals with and without PTSD symptoms after separating out veterans failing the WMT. These findings highlight the importance of assessing respondent validity in future research examining cognitive functioning in psychiatric illness and warrant further consideration of prior studies reporting PTSD-associated cognitive deficits.