Clinical research requires a competent workforce of clinical research professionals (CRPs) who are well-trained to perform varied and complex tasks within their roles. The Joint Task Force for Clinical Trial Competency (JTF) framework established essential domains for conducting high-quality clinical research that can guide professional development of CRPs. The Research Professionals Network (RPN) Workshops were established in 2017 to focus on developing ongoing inter-institutional, peer-led, JTF-centric continuing education for CRPs. Four institutions and their affiliates are part of the collaboration.

Workshop participant survey data and other metrics were collected over four academic years. Both quantitative and qualitative analyses were performed to assess participant experience and identify relevant themes.

Participants demonstrated overall high satisfaction with the workshops and significantly value the interpersonal, inter-institutional collaboration made possible through the workshops.

These inter-institutional RPN Workshops have evolved into a Community of Practice, which can be expanded into future opportunities.

Patients with temporal lobe epilepsy (TLE) commonly show memory deficits on neuropsychological tests. The BVMT-R is a widely used test of visual learning and memory that involves accurately reproducing an array of figures in the correct special location. The present study examined performance processes of visual memory in presurgical patients with TLE, including item (i.e., accuracy) and associative memory (i.e., location), which have been shown to be dissociable in studies of visual memory in other neurologic populations.

Participants included nine patients with left TLE (67% female; 67% left-handed; mean age = 46.15 years, range = 24-55; mean education = 14.8 years, range = 9-18) and six patients with right TLE (17% female; 33% left-handed; mean age = 57.64 years, range = 22-62; mean education = 15.52 years, range 11-18). Mean duration of epilepsy was 19 years. Participants had an average of two failed anti-seizure medications prior to surgery. TLE groups were compared to 22 healthy controls (36% female; 14% left-handed; mean age = 33.68 years, range = 2253; mean education = 17.66 years, range = 1620). All participants completed comprehensive neuropsychological testing at a large Northeastern medical center. The BVMT-R was scored using standard and novel scoring paradigms. All data were retrospectively reviewed from archival datasets.

MANCOVA results indicated a significant multivariate main effect for group membership and standard BVMT-R scoring after controlling for level of education, Wilks’ A = 0.59, F(4, 64) = 4.91, p = .002. The multivariate partial eta squared (np2) of .58 indicated a strong relationship between group membership and both immediate and delayed recall, with the control group performing better overall. The TLE groups did not perform significantly different from each other. A significant multivariate main effect for group and novel BVMT-R scoring was found (also controlling for education), Wilks’ A = 0.42, F(8, 58) = 3.97, p = .001. Overall, the control group demonstrated better item learning with no significant difference between TLE groups observed. Both the control (M = (16.5, SD = 2.04) and left TLE (M = 12.33, SD = 4.03) showed stronger associative learning compared to the right TLE group (M = 10.2, SD = 4.27). For item and location delayed recall, controls (M = 4.82, SD = 1.62) had more accurate recall compared to left TLE (M = 1.56, SD = 2.04) with a trend toward better performance compared to the right TLE patients (M = 2.6, SD = 1.82); the TLE groups performed similarly. No difference was observed for associative delayed recall between the three groups.

Patients with right TLE showed worse associative learning compared to left TLE, while performance was generally comparable to their right TLE counterparts on other novel BVMT-R scoring paradigms. Unsurprisingly, patients with TLE performed worse on BVMT-R using standard scoring procedures, though no lateralizing effect was observed. While these findings suggest that associative visual learning weakness may be characteristic of right TLE, findings should be interpreted cautiously the given small sample size and demographic considerations (i.e., uneven gender distribution, lack of data on ethnicity/race).

Anterior temporal lobectomy is a common surgical approach for medication-resistant temporal lobe epilepsy (TLE). Prior studies have shown inconsistent findings regarding the utility of presurgical intracarotid sodium amobarbital testing (IAT; also known as Wada test) and neuroimaging in predicting postoperative seizure control. In the present study, we evaluated the predictive utility of IAT, as well as structural magnetic resonance imaging (MRI) and positron emission tomography (PET), on long-term (3-years) seizure outcome following surgery for TLE.

Patients consisted of 107 adults (mean age=38.6, SD=12.2; mean education=13.3 years, SD=2.0; female=47.7%; White=100%) with TLE (mean epilepsy duration =23.0 years, SD=15.7; left TLE surgery=50.5%). We examined whether demographic, clinical (side of resection, resection type [selective vs. non-selective], hemisphere of language dominance, epilepsy duration), and presurgical studies (normal vs. abnormal MRI, normal vs. abnormal PET, correctly lateralizing vs. incorrectly lateralizing IAT) were associated with absolute (cross-sectional) seizure outcome (i.e., freedom vs. recurrence) with a series of chi-squared and t-tests. Additionally, we determined whether presurgical evaluations predicted time to seizure recurrence (longitudinal outcome) over a three-year period with univariate Cox regression models, and we compared survival curves with Mantel-Cox (log rank) tests.

Demographic and clinical variables (including type [selective vs. whole lobectomy] and side of resection) were not associated with seizure outcome. No associations were found among the presurgical variables. Presurgical MRI was not associated with cross-sectional (OR=1.5, p=.557, 95% CI=0.4-5.7) or longitudinal (HR=1.2, p=.641, 95% CI=0.4-3.9) seizure outcome. Normal PET scan (OR= 4.8, p=.045, 95% CI=1.0-24.3) and IAT incorrectly lateralizing to seizure focus (OR=3.9, p=.018, 95% CI=1.2-12.9) were associated with higher odds of seizure recurrence. Furthermore, normal PET scan (HR=3.6, p=.028, 95% CI =1.0-13.5) and incorrectly lateralized IAT (HR= 2.8, p=.012, 95% CI=1.2-7.0) were presurgical predictors of earlier seizure recurrence within three years of TLE surgery. Log rank tests indicated that survival functions were significantly different between patients with normal vs. abnormal PET and incorrectly vs. correctly lateralizing IAT such that these had seizure relapse five and seven months earlier on average (respectively).

Presurgical normal PET scan and incorrectly lateralizing IAT were associated with increased risk of post-surgical seizure recurrence and shorter time-to-seizure relapse.

Patients with Parkinson’s disease (PD) commonly show deficits on tests of visuospatial functioning. The Identi-Fi is a new measure of visual organization and recognition composed of two components. The Visual Recognition (VR) subtest asks persons to identify an object that has been broken its pieces and rearranged, akin to the Hooper Visual Organization Test, but using updated and colorful pictures. The Visual Matching (VM) subtest involves showing the same stimuli, but the examinee must select the correct response from among five choices (1 correct and 4 foils), placing greater demand on visuospatial discrimination. Together, the two subtests comprise the Visual Organization Index (VOI), reflecting overall visual processing and organization ability. The present study examined performance on the Identi-Fi in patients with PD and its association with other aspects of cognition.

Participants were 23 patients with PD (95% male; mean age = 69.7 years [SD = 7.8], range = 47-79) and 12 patients with cognitive concerns (CC) who were intact on neuropsychological testing (excluding consideration of Identi-Fi scores; 50% male, mean age = 71.08 [SD = 6.27], range = 60-78) seen for a neuropsychological evaluation at a large Northeastern medical center. As part of a larger battery, patients completed the Identi-Fi, Trail Making Test (TMT), Category Fluency, Test of Premorbid Functioning (TOPF), and Brief Visuospatial Memory Test, Revised (BVMT-R).

The PD group performed significantly worse than the CC group on VR and VM, as well as VOI, of the Identi-Fi (p < .001). Within the PD group, poorer VR, VM, and VOI performance was associated with lower scores on the TOPF (p < .05), BVMT-R learning (p < .05) and delayed recall (p < .05), as well as TMT Parts A and B (p < .05). VR was significantly correlated with Category Fluency (p < .05), while a trend was seen for the association between VOI and Category Fluency (p = .094).

Identi-Fi performance was worse in the PD group than the CC group, which is consistent with prior research indicating that visuospatial processing is often abnormal in patients with PD. Furthermore, findings indicate that poorer performance on the Identi-Fi in the PD group is associated with poorer cognitive functioning in other domains (i.e., visuospatial learning and memory, processing speed, cognitive flexibility, and semantic fluency), as well as lower premorbid intellectual functioning. While these findings suggest that the Identi-Fi is useful in identifying visuospatial dysfunction in PD, findings should be interpreted with caution given the small sample sizes and uneven gender distribution

Patients with Post-Acute COVID Syndrome (PACS) are reported to commonly experience a variety of cognitive, physical, and neuropsychiatric symptoms well beyond the acute phase of the illness. Notably, concerns involving mood, fatigue, and physical symptoms (e.g., pain, headaches) following COVID-19 appears to be especially prevalent. It is unclear, however, the extent to which such symptoms are associated with cognitive problems in patients with PACS. In the present study, we examined the prevalence of cognitive impairment in a sample of patients with PACS, as well as the relationship between cognitive functioning and several non-cognitive symptoms.

Participants were 38 patients with PACS [71.1% female; mean age = 48.03 years (SD = 11.60) and years of education = 15.26 years (SD = 2.60)] seen for a neuropsychological evaluation at a large Northeastern medical center at least three months from the time of COVID-19 diagnosis (per PCR test). As part of a larger battery, patients completed the Hopkins Verbal Learning Test- Revised (HVLT, learning and delayed recall), Trail Making Test (TMT; time to complete parts A and B), Controlled Oral Word Association Test (COWAT total correct), and Animals (total correct). They also were administered the Chalder Fatigue Scale-11 (CFS-11), Beck Depression Inventory-II (BDI-II), Beck Anxiety Inventory (BAI), and Patient Health Questionnaire (PHQ-15). The percentage of patients with scores in the impaired range (z < -1.5) on cognitive tests was determined. Correlations between cognitive and non-cognitive measures were also examined.

The most frequent impairment was seen for COWAT (21.2%), followed by TMT-A and TMT-B (both 13.9%), then category fluency (9.1%). No patients were impaired on HVLT-R Learning and only one (4%) for HVLT-R Delayed Recall. Overall, the sample endorsed considerable depression, anxiety, fatigue, as well as physical symptoms. Greater fatigue was associated with worse verbal learning, processing speed, cognitive flexibility, and verbal fluency (letter and category). Worse physical symptom severity was related to poorer verbal delayed recall and cognitive flexibility. Greater anxiety was also associated with worse cognitive flexibility, while more severe depression was related to poorer category fluency.

In our sample of patients with PACS, seen for evaluation several months since contracting COVID-19, phonemic fluency was the most common cognitive impairment, though less than a quarter were impaired on any given cognitive test. Importantly, several associations were observed between cognitive test performance and non-cognitive symptoms commonly endorsed by patients with PACS. These findings highlight the importance of assessing multiple factors potentially contributing to cognitive impairment in these patients. Interventions designed to address such symptoms may be helpful in ameliorating cognitive functioning in those with PACS.

Mild cognitive impairment (MCI) is characterized by subjective and objective memory concerns, though additional cognitive concerns are commonly reported, including changes in executive functions (EF). Rabin et al. (2006) showed that a sample of research participants with MCI endorsed problems with their EFs, especially working memory. Similarly, those with subjective cognitive dysfunction (SCD) also reported greater difficulty with aspects of their EF than a healthy comparison sample of older adults (HC). In the present study, we investigated subjective EF in clinical samples of older adults with MCI or SCD, which represents a more naturalistic sample relative to a research sample. Furthermore, we evaluated whether subjective EF varied in these groups depending on whether patients were "young-old" versus "old-old" given prior research indicating objective cognitive differences between these age groups.

Participants were 135 older adults (53 MCI, 52 SCD, and 30 HC) matched for age (p = .116) and education (p = .863). Dichotomous categorization of age used the sample median (72 years) as cutoff score with 72 participants in the young-old group (mean age = 65.8 ± 4.7 years) and 63 in the old-old group (mean age = 78.1 ± 3.7 years). Participants completed the Behavior Rating Inventory of Executive Function-Adult (BRIEF-A), assessing executive functions in everyday life over the past month. The BRIEF-A yields an overall score (Global Executive Composite [GEC]) composed of two index scores (Behavioral Regulation Index [BRI] and Metacognition Index [MI]) and nine clinical scales (Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials). A diagnosis by age-group multivariate analysis of variance (MANOVA) with post-hoc comparisons for diagnosis using a Tukey HSD correction was conducted using SPSS Version 24.

MCI and SCD groups endorsed worse EF on all three index scores (ps < .005) and all nine clinical scales (ps < .05) relative to the HC group, and the MCI group reported worse initiation relative to the SCD group. Additionally, worse executive functions on all three index scores (ps < .05) and four clinical scales (ps < .05; emotional control, self-monitoring, planning/organization, and task monitoring) were reported by the young-old group relative to the old-old group. No diagnosis by age-group interactions were observed.

Problems with aspects of EF were endorsed by older adults with MCI and SCD compared to HCs across all indices and clinical scales; however, only initiation was reported to be worse in MCI than those with SCD. Additionally, the young-old group endorsed having worse EF than the old-old group across BRIEF-A indices and several more specific aspects of EF, without a moderating effect of diagnosis. These findings highlight the importance of assessing subjective EF in older adults, as they may be early indicators of cognitive change, prior to objective evidence of cognitive decline. Furthermore, results also point to differences in how the young-old and old-old perceive their EF in everyday life.

Rapid antigen detection tests (Ag-RDT) for SARS-CoV-2 with emergency use authorization generally include a condition of authorization to evaluate the test’s performance in asymptomatic individuals when used serially. We aim to describe a novel study design that was used to generate regulatory-quality data to evaluate the serial use of Ag-RDT in detecting SARS-CoV-2 virus among asymptomatic individuals.

This prospective cohort study used a siteless, digital approach to assess longitudinal performance of Ag-RDT. Individuals over 2 years old from across the USA with no reported COVID-19 symptoms in the 14 days prior to study enrollment were eligible to enroll in this study. Participants throughout the mainland USA were enrolled through a digital platform between October 18, 2021 and February 15, 2022. Participants were asked to test using Ag-RDT and molecular comparators every 48 hours for 15 days. Enrollment demographics, geographic distribution, and SARS-CoV-2 infection rates are reported.

A total of 7361 participants enrolled in the study, and 492 participants tested positive for SARS-CoV-2, including 154 who were asymptomatic and tested negative to start the study. This exceeded the initial enrollment goals of 60 positive participants. We enrolled participants from 44 US states, and geographic distribution of participants shifted in accordance with the changing COVID-19 prevalence nationwide.

The digital site-less approach employed in the “Test Us At Home” study enabled rapid, efficient, and rigorous evaluation of rapid diagnostics for COVID-19 and can be adapted across research disciplines to optimize study enrollment and accessibility.