In response to the COVID-19 pandemic, we rapidly implemented a plasma coordination center, within two months, to support transfusion for two outpatient randomized controlled trials. The center design was based on an investigational drug services model and a Food and Drug Administration-compliant database to manage blood product inventory and trial safety.

A core investigational team adapted a cloud-based platform to randomize patient assignments and track inventory distribution of control plasma and high-titer COVID-19 convalescent plasma of different blood groups from 29 donor collection centers directly to blood banks serving 26 transfusion sites.

We performed 1,351 transfusions in 16 months. The transparency of the digital inventory at each site was critical to facilitate qualification, randomization, and overnight shipments of blood group-compatible plasma for transfusions into trial participants. While inventory challenges were heightened with COVID-19 convalescent plasma, the cloud-based system, and the flexible approach of the plasma coordination center staff across the blood bank network enabled decentralized procurement and distribution of investigational products to maintain inventory thresholds and overcome local supply chain restraints at the sites.

The rapid creation of a plasma coordination center for outpatient transfusions is infrequent in the academic setting. Distributing more than 3,100 plasma units to blood banks charged with managing investigational inventory across the U.S. in a decentralized manner posed operational and regulatory challenges while providing opportunities for the plasma coordination center to contribute to research of global importance. This program can serve as a template in subsequent public health emergencies.

The number of test translations and adaptations has risen exponentially over the last two decades, and these processes are now becoming a common practice. The International Test Commission (ITC) Guidelines for Translating and Adapting Tests (Second Edition, 2017) offer principles and practices to ensure the quality of translated and adapted tests. However, they are not specific to the cognitive processes examined with clinical neuropsychological measures. The aim of this publication is to provide a specialized set of recommendations for guiding neuropsychological test translation and adaptation procedures.

The International Neuropsychological Society’s Cultural Neuropsychology Special Interest Group established a working group tasked with extending the ITC guidelines to offer specialized recommendations for translating/adapting neuropsychological tests. The neuropsychological application of the ITC guidelines was formulated by authors representing over ten nations, drawing upon literature concerning neuropsychological test translation, adaptation, and development, as well as their own expertise and consulting colleagues experienced in this field.

A summary of neuropsychological-specific commentary regarding the ITC test translation and adaptation guidelines is presented. Additionally, examples of applying these recommendations across a broad range of criteria are provided to aid test developers in attaining valid and reliable outcomes.

Establishing specific neuropsychological test translation and adaptation guidelines is critical to ensure that such processes produce reliable and valid psychometric measures. Given the rapid global growth experienced in neuropsychology over the last two decades, the recommendations may assist researchers and practitioners in carrying out such endeavors.

Human immunodeficiency virus (HIV)-associated neurocognitive disorder (HAND) prevalence is expected to increase in East Africa as treatment coverage increases, survival improves, and this population ages. This study aimed to better understand the current cognitive phenotype of this newly emergent population of older combination antiretroviral therapy (cART)-treated people living with HIV (PLWH), in which current screening measures lack accuracy. This will facilitate the refinement of HAND cognitive screening tools for this setting.

This is a secondary analysis of 253 PLWH aged ≥50 years receiving standard government HIV clinic follow-up in Kilimanjaro, Tanzania. They were evaluated with a detailed locally normed low-literacy neuropsychological battery annually on three occasions and a consensus panel diagnosis of HAND by Frascati criteria based on clinical evaluation and collateral history.

Tests of verbal learning and memory, categorical verbal fluency, visual memory, and visuoconstruction had an area under the receiver operating characteristic curve >0.7 for symptomatic HAND (s-HAND) (0.70–0.72; p < 0.001 for all tests). Tests of visual memory, verbal learning with delayed recall and recognition memory, psychomotor speed, language comprehension, and categorical verbal fluency were independently associated with s-HAND in a logistic mixed effects model (p < 0.01 for all). Neuropsychological impairments varied by educational background.

A broad range of cognitive domains are affected in older, well-controlled, East African PLWH, including those not captured in widely used screening measures. It is possible that educational background affects the observed cognitive impairments in this setting. Future screening measures for similar populations should consider assessment of visual memory, verbal learning, language comprehension, and executive and motor function.

Mobile phone reminding apps can be used by people with acquired brain injury (ABI) to compensate for their memory impairments. However off-the-shelf apps may be difficult to use. ApplTree has been developed to be accessible to this group, compared to off-the-shelf reminding apps such as Google Calendar. This pilot feasibility trial aimed to establish the feasibility of running (and issues that should be addressed to complete) a randomised controlled trial comparing ApplTree to Google Calendar in an ABI community treatment setting.

Adults with self or other reported memory difficulty after an ABI were enrolled (n=39). Those who completed the baseline phase were randomised (n=29) and randomly allocated to the Google Calendar or ApplTree intervention. They were shown a 30 minute video tutorial of the app and an assessment on their ability to use it. Timely completion of everyday memory tasks were measured for a 3 week pre-intervention baseline and 3 week post-intervention follow-up phase. Participants also completed neuropsychological tests assessing memory, attention and executive function and gave qualitative feedback on the app and their experience in the trial.

Recruitment rate was 58% of the target (29 were randomised, n=50 was the target in 2 years). Retention rate was 65.5% and adherence rate was 57.9%. While the feasibility trial was not powered to calculate efficacy, there was a 13% increase in everyday memory tasks completed on time for those in the ApplTree group (n=10) compared to baseline and no change for the Google Calendar group (n=9). Feasibility results indicate 72 participants would need to fully complete a trial to detect the minimum clinically important difference (12.5% increase in successful performance of everyday memory tasks) in the efficacy of ApplTree compared to Google Calendar, should such a difference exist.

The challenges with recruitment of people receiving community care for ABI are highlighted in this trial and discussed along with the impact of the Covid-19 pandemic. Methodological considerations for researchers or clinicians looking to measure everyday memory ability are discussed. The majority (19 of 21) of participants who were given an app were capable of learning to use it during an hour-long session. This indicates it is a feasible intervention that community ABI services could offer. Participant feedback highlighted the merits of design features implemented in ApplTree that can improve the uptake and utility of reminding apps.

A systematic approach is vital for adapting neuropsychological tests developed and validated in western monocultural, educated and English-speaking populations. However, rigorous and uniform methods are often not implemented during adaptation of neuropsychological tests and cognitive screening tools across different languages and cultures. This has serious clinical implications. Our group has adapted the Addenbrooke’s Cognitive Examination (ACE) III for the Bengali speaking population in India. We have taken a 'culture-specific’ approach to adaptation and illustrate this by describing the process of adapting the ACE III naming sub-test, with a focus on the process of selecting culturally appropriate and psychometrically reliable items

Two studies were conducted in seven phases for adapting the ACE III naming test. Twenty-three items from the naming test in the English and the different Indian ACE-R versions were administered to healthy Bengali speaking literate adults to determine image agreement, naming and familiarity of the items. Eleven items were identified as outliers. We then included 16 culturally appropriate items that were semantically similar to the items in the selected ACE-R versions of which 3 were identified as outliers. The final corpus consisting of 24 items was administered to 30 patients with mild cognitive Impairment, Alzheimer’s disease and vascular dementia, and 60 healthy controls matched for age and education to determine which items in the corpus best discriminated patients and the controls, and to examine their difficulty levels.

The ACE III Bengali naming test with an internal consistency of .76 included 12 psychometrically reliable, culturally relevant high naming-high familiarity and high naming-low familiarity living and non-living items. Item difficulty ranged from .47 to .88 and had discrimination indices >.44.

A key question for test development/adaptation is whether to aim for culture-broad or culture-specific tests. Either way, a systematic approach to test adaption will increase the likelihood that a test is appropriate for the linguistic/cultural context in which it is intended to be used. Adaptation of neuropsychological tests based on a familiarity driven approach helps to reduce cultural bias at the content level. This coupled with appropriate item selection statistics helps to improve the validity of the adapted tests and ensure cross-cultural comparability of test scores both across and within nations.

Social cognition is frequently impaired following an acquired brain injury (ABI) but often overlooked in clinical assessments. There are few validated and appropriate measures of social cognitive abilities for ABI patients. The current study examined the validity of the Edinburgh Social Cognition Test (ESCoT, Baksh et al., 2018) in measuring social cognition following an ABI.

Forty-one patients with ABI were recruited from a rehabilitation service and completed measures of general ability, executive functions and social cognition (Faux Pas; FP, Reading the Mind in the Eyes; RME, Social Norms Questionnaire; SNQ and the ESCoT). Forty-one controls matched on age, sex and years of education also performed the RME, SNQ and ESCoT.

A diagnosis of ABI was significantly associated with poorer performance on all ESCoT measures and RME while adjusting for age, sex and years of education. In ABI patients, the ESCoT showed good internal consistency with its subcomponents and performance correlated with the other measures of social cognition demonstrating convergent validity. Better Trail Making Test performance predicted better ESCoT total, RME and SNQ scores. Higher TOPF IQ was associated with higher RME scores, while higher WAIS-IV working memory predicted better FP performance.

The ESCoT is a brief, valid and internally consistent assessment tool able to detect social cognition deficits in neurological patients. Given the prevalence of social cognition deficits in ABI and the marked impact these can have on an individual’s recovery, this assessment can be a helpful addition to a comprehensive neuropsychological assessment.

To propose a set of internationally harmonized procedures and methods for assessing neurocognitive functions, smell, taste, mental, and psychosocial health, and other factors in adults formally diagnosed with COVID-19 (confirmed as SARS-CoV-2 + WHO definition).

We formed an international and cross-disciplinary NeuroCOVID Neuropsychology Taskforce in April 2020. Seven criteria were used to guide the selection of the recommendations’ methods and procedures: (i) Relevance to all COVID-19 illness stages and longitudinal study design; (ii) Standard, cross-culturally valid or widely available instruments; (iii) Coverage of both direct and indirect causes of COVID-19-associated neurological and psychiatric symptoms; (iv) Control of factors specifically pertinent to COVID-19 that may affect neuropsychological performance; (v) Flexibility of administration (telehealth, computerized, remote/online, face to face); (vi) Harmonization for facilitating international research; (vii) Ease of translation to clinical practice.

The three proposed levels of harmonization include a screening strategy with telehealth option, a medium-size computerized assessment with an online/remote option, and a comprehensive evaluation with flexible administration. The context in which each harmonization level might be used is described. Issues of assessment timelines, guidance for home/remote assessment to support data fidelity and telehealth considerations, cross-cultural adequacy, norms, and impairment definitions are also described.

The proposed recommendations provide rationale and methodological guidance for neuropsychological research studies and clinical assessment in adults with COVID-19. We expect that the use of the recommendations will facilitate data harmonization and global research. Research implementing the recommendations will be crucial to determine their acceptability, usability, and validity.

Trainees and investigators from underrepresented minority (URM) backgrounds face unique challenges to establishing successful careers in clinical and translational research. Structured training for mentors is an important mechanism to increase the diversity of the research workforce. This article presents data from an evaluation of the University of California, San Francisco (UCSF) Center for AIDS Research (CFAR) Mentoring the Mentors program aimed at improving mentors’ competency in working with diverse mentees in HIV research.

Mentors from around the USA who had in one of seven separate 2-day training workshops conducted from 2013 to 2020 were invited to participate in an online evaluation survey of their experiences with the training and their subsequent mentoring activities.

There was a high response rate (80%) among the 226 mentors invited to complete the survey. The 180 respondents were diverse in demographics, professional disciplines, and geographic distribution. Quantitative and qualitative data indicate a lasting positive impact of the training, with sustained improvements documented on a validated measure of self-appraised mentoring competency. Respondents also endorsed high interest in future, follow-up training with continued focus on topics related to mentoring in the context of diversity.

The evaluation of the UCSF CFAR Mentoring the Mentors program showed lasting impact in improving mentoring practices, coupled with high interest in continued in-depth training in areas focused on diversity, equity, and inclusion.

In the absence of pyuria, positive urine cultures are unlikely to represent infection. Conditional urine reflex culture policies have the potential to limit unnecessary urine culturing. We evaluated the impact of this diagnostic stewardship intervention.

We conducted a retrospective, quasi-experimental (nonrandomized) study, with interrupted time series, from August 2013 to January 2018 to examine rates of urine cultures before versus after the policy intervention. We compared 3 intervention sites to 3 control sites in an aggregated series using segmented negative binomial regression.

The study included 6 acute-care hospitals within the Veterans’ Health Administration across the United States.

Adult patients with at least 1 urinalysis ordered during acute-care admission, excluding pregnant patients or those undergoing urological procedures, were included.

At the intervention sites, urine cultures were performed if a preceding urinalysis met prespecified criteria. No such restrictions occurred at the control sites. The primary outcome was the rate of urine cultures performed per 1,000 patient days. The safety outcome was the rate of gram-negative bloodstream infection per 1,000 patient days.

The study included 224,573 urine cultures from 50,901 admissions in 24,759 unique patients. Among the intervention sites, the overall average number of urine cultures performed did not significantly decrease relative to the preintervention period (5.9% decrease; P = 0.8) but did decrease by 21% relative to control sites (P < .01). We detected no significant difference in the rates of gram-negative bloodstream infection among intervention or control sites (P = .49).

Conditional urine reflex culture policies were associated with a decrease in urine culturing without a change in the incidence of gram-negative bloodstream infection.