The Verbal Naming Test (VNT) is an auditory-based measure of naming or word finding. The current multisite study sought to evaluate the reliability and validity of the VNT in the detection of major and mild neurocognitive disorder (NCD).

This study analyzed clinical data from two outpatient neuropsychology clinics (N = 188 and N = 77) and a geriatric primary care clinic (N = 104). Cronbach’s alpha and Spearman correlations with other measures were calculated. ROC analyses were used to calculate sensitivity, specificity, positive predictive power, and negative predictive power for the detection of major and mild NCD per DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) criteria.

The VNT was found to have strong reliability (Cronbach’s alpha = .90) and high convergent validity with a commonly used picture-naming task (NAB Naming, Spearman’s rho = .65, p < .001). The VNT showed good sensitivity and specificity for the detection of NCDs, particularly major NCD, with an area under the curve of .85, sensitivity of .80, and specificity of .75. A possible discontinue rule is also suggested for clinicians to use.

These findings provide compelling evidence for the use of the VNT to detect neurocognitive impairment in a clinical setting. The VNT provides a reliable alternative to picture-naming tasks, which may be advantageous when working with visually impaired patients or conducting evaluations over telehealth.

The use of online platforms for pediatric healthcare research is timely, given the current pandemic. These platforms facilitate trial efficiency integration including electronic consent, randomization, collection of patient/family survey data, delivery of an intervention, and basic data analysis.

We created an online digital platform for a multicenter study that delivered an intervention for sleep disorders to parents of children with autism spectrum disorder (ASD). An advisory parent group provided input. Participants were randomized to receive either a sleep education pamphlet only or the sleep education pamphlet plus three quick-tips sheets and two videos that reinforced the material in the pamphlet (multimedia materials). Three measures – Family Inventory of Sleep Habits (FISH), Children’s Sleep Habits Questionnaire modified for ASD (CSHQ-ASD), and Parenting Sense of Competence (PSOC) – were completed before and after 12 weeks of sleep education.

Enrollment exceeded recruitment goals. Trial efficiency was improved, especially in data entry and automatic notification of participants related to survey completion. Most families commented favorably on the study. While study measures did not improve with treatment in either group (pamphlet or multimedia materials), parents reporting an improvement of ≥3 points in the FISH score showed a significantly improved change in the total CSHQ (P = 0.038).

Our study demonstrates the feasibility of using online research delivery platforms to support studies in ASD, and more broadly, pediatric clinical and translational research. Online platforms may increase participant inclusion in enrollment and increase convenience and safety for participants and study personnel.

Dialysis patients may not have access to conventional renal replacement therapy (RRT) following disasters. We hypothesized that improvised renal replacement therapy (ImpRRT) would be comparable to continuous renal replacement therapy (CRRT) in a porcine acute kidney injury model.

Following bilateral nephrectomies and 2 hours of caudal aortic occlusion, 12 pigs were randomized to 4 hours of ImpRRT or CRRT. In the ImpRRT group, blood was circulated through a dialysis filter using a rapid infuser to collect the ultrafiltrate. Improvised replacement fluid, made with stock solutions, was infused pre-pump. In the CRRT group, commercial replacement fluid was used. During RRT, animals received isotonic crystalloids and norepinephrine.

There were no differences in serum creatinine, calcium, magnesium, or phosphorus concentrations. While there was a difference between groups in serum potassium concentration over time (P < 0.001), significance was lost in pairwise comparison at specific time points. Replacement fluids or ultrafiltrate flows did not differ between groups. There were no differences in lactate concentration, isotonic crystalloid requirement, or norepinephrine doses. No difference was found in electrolyte concentrations between the commercial and improvised replacement solutions.

The ImpRRT system achieved similar performance to CRRT and may represent a potential option for temporary RRT following disasters.

Training for the clinical research workforce does not sufficiently prepare workers for today’s scientific complexity; deficiencies may be ameliorated with training. The Enhancing Clinical Research Professionals’ Training and Qualifications developed competency standards for principal investigators and clinical research coordinators.

Clinical and Translational Science Awards representatives refined competency statements. Working groups developed assessments, identified training, and highlighted gaps.

Forty-eight competency statements in 8 domains were developed.

Training is primarily investigator focused with few programs for clinical research coordinators. Lack of training is felt in new technologies and data management. There are no standardized assessments of competence.

The translation of discoveries to drugs, devices, and behavioral interventions requires well-prepared study teams. Execution of clinical trials remains suboptimal due to varied quality in design, execution, analysis, and reporting. A critical impediment is inconsistent, or even absent, competency-based training for clinical trial personnel.

In 2014, the National Center for Advancing Translational Science (NCATS) funded the project, Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ), aimed at addressing this deficit. The goal was to ensure all personnel are competent to execute clinical trials. A phased structure was utilized.

This paper focuses on training recommendations in Good Clinical Practice (GCP). Leveraging input from all Clinical and Translational Science Award hubs, the following was recommended to NCATS: all investigators and study coordinators executing a clinical trial should understand GCP principles and undergo training every 3 years, with the training method meeting the minimum criteria identified by the International Conference on Harmonisation GCP.

We anticipate that industry sponsors will acknowledge such training, eliminating redundant training requests. We proposed metrics to be tracked that required further study. A separate task force was composed to define recommendations for metrics to be reported to NCATS.

Depression and anxiety in Parkinson's disease are common and frequently co-morbid, with significant impact on health outcome. Nevertheless, management is complex and often suboptimal. The existence of clinical subtypes would support stratified approaches in both research and treatment.

Five hundred and thirteen patients with Parkinson's disease were assessed annually for up to 4 years. Latent transition analysis (LTA) was used to identify classes that may conform to clinically meaningful subgroups, transitions between those classes over time, and baseline clinical and demographic features that predict common trajectories.

In total, 64.1% of the sample remained in the study at year 4. LTA identified four classes, a ‘Psychologically healthy’ class (approximately 50%), and three classes associated with psychological distress: one with moderate anxiety alone (approximately 20%), and two with moderate levels of depression plus moderate or severe anxiety. Class membership tended to be stable across years, with only about 15% of individuals transitioning between the healthy class and one of the distress classes. Stable distress was predicted by higher baseline depression and psychiatric history and younger age of onset of Parkinson's disease. Those with younger age of onset were also more likely to become distressed over the course of the study.

Psychopathology was characterized by relatively stable anxiety or anxious-depression over the 4-year period. Anxiety, with or without depression, appears to be the prominent psychopathological phenotype in Parkinson's disease suggesting a pressing need to understanding its mechanisms and improve management.

Multimodal treatment options in head and neck squamous cell carcinoma have allowed for greater control of locoregional disease, but this has not translated into a significant overall survival advantage for patients. This is partially because these treatment modalities have no influence over the rate of development of distant metastases.

This article summarises the current methods of detecting circulating and disseminated tumour cells. It also discusses how these cells can offer prognostic value in head and neck squamous cell carcinoma, and considers questions posed by the identification of these cells.

A literature search of relevant journal articles was performed using ScienceDirect and PubMed databases, and a general article search was conducted using the online search engine Google.

The evidence presented in this article indicates that circulating tumour cells and disseminated tumour cells may be clinically useful as prognostic markers or in the assessment of response to treatment in head and neck squamous cell carcinoma.