"My Blood, You Know, My Biology Being out There…": Consent and Participant Control of Biological Samples.

The widespread and persistent underrepresentation of groups experiencing health disparities in research involving biospecimens is a barrier to scientific knowledge and advances in health equity. To ensure that all groups have the opportunity to participate in research and feel welcome and safe doing so, we must understand how research studies may be shaped to promote inclusion. In this study, we explored the decision to participate in hypothetical research scenarios among African American adults (n = 169) that varied on the basis of four attributes (form of consent, reason for research, institutional affiliation and race of the researcher).

The Critical Period After Stroke Study (CPASS) Upper Extremity Treatment Protocol.

Objective: To present the development of a novel upper extremity (UE) treatment and assess how it was delivered in the Critical Periods After Stroke Study (CPASS), a phase II randomized controlled trial (RCT).

Design: Secondary analysis of data from the RCT.

Setting: Inpatient and outpatient settings the first year after stroke.

Factors Associated with Interviewers' Evaluations of Respondents' Performance in Telephone Interviews: Behavior, Response Quality Indicators, and Characteristics of Respondents and Interviewers.

Interviewers' postinterview evaluations of respondents' performance (IEPs) are paradata, used to describe the quality of the data obtained from respondents. IEPs are driven by a combination of factors, including respondents' and interviewers' sociodemographic characteristics and what actually transpires during the interview. However, relatively few studies examine how IEPs are associated with features of the response process, including facets of the interviewer-respondent interaction and patterns of responding that index data quality.

Conventional clock drawing tests have low to moderate reliability and validity for detecting subtle cognitive impairments in community-dwelling older adults.

Background: Early identification of subtle cognitive decline in community-dwelling older adults is critical, as mild cognitive impairment contributes to disability and can be a precursor to dementia. The clock drawing test (CDT) is a widely adopted cognitive screening measure for dementia, however, the reliability and validity of paper-and-pencil CDT scoring scales for mild cognitive impairment in community samples of older adults is less well established. We examined the reliability, sensitivity and specificity, and construct validity of two free-drawn clock drawing test scales-the Rouleau System and the Clock Drawing Interpretation Scale (CDIS)-for subtle cognitive decline in community-dwelling older adults.

"I Want to Know Everything ... ": The Return of Research Results and the Importance of Transparency in the Acceptability of Lumbar Punctures for African American Older Adults.

Background: Although African Americans experience the highest risk of Alzheimer's disease (AD), they are dramatically underrepresented in preclinical biomarker research. This is especially true for studies involving lumbar puncture as it may involve more perceived risk even for those participants who are otherwise supportive of research.

Objective: To understand the unique concerns of African American participants regarding biomarker studies involving lumbar puncture who demonstrate support for AD research.

Loss-of-Set and Strategy Application on the Menu Task: An Exploratory Study.

The Menu Task (MT) is an occupational therapy screening measure designed to identify people in need of functional cognitive (FC) assessment. To explore whether test-taker strategy selection on the MT is clinically informative. Using a cross-sectional design we administered assessments of FC including the MT and the After MT interview, cognitive screening measures, and self-report instrumental activities of daily living assessment to a convenience sample of 55 community-dwelling adults.

Retention of Study Partners in Longitudinal Studies of Alzheimer Disease.

Background: Study partners are required for all participants at Alzheimer's Disease Research Centers (ADRCs). Study partners' attitudes and beliefs may contribute to missed visits and negatively impact retention of participants in longitudinal AD studies.

Objective: Study partners (N = 212) of participants (Clinical Dementia Rating® [CDR]≤2) at four ADRCs were randomly surveyed to examine their facilitators and barriers to continued participation in AD studies.

Barriers to and solutions for representative inclusion across the lifespan and in life course research: The need for structural competency highlighted by the COVID-19 pandemic.

Exclusion of special populations (older adults; pregnant women, children, and adolescents; individuals of lower socioeconomic status and/or who live in rural communities; people from racial and ethnic minority groups; individuals from sexual or gender minority groups; and individuals with disabilities) in research is a pervasive problem, despite efforts and policy changes by the National Institutes of Health and other organizations. These populations are adversely impacted by social determinants of health (SDOH) that reduce access and ability to participate in biomedical research. In March 2020, the Northwestern University Clinical and Translational Sciences Institute hosted the "Lifespan and Life Course Research: integrating strategies" "Un-Meeting" to discuss barriers and solutions to underrepresentation of special populations in biomedical research.

Interpreting the CPASS Trial: Do Not Shift Motor Therapy to the Subacute Phase.

The Critical Periods After Stroke Study (CPASS, n = 72) showed that, compared to controls, an additional 20 hours of intensive upper limb therapy led to variable gains on the Action Research Arm Test depending on when therapy was started post-stroke: the subacute group (2-3 months) improved beyond the minimal clinically important difference and the acute group (0-1 month) showed smaller but statistically significant improvement, but the chronic group (6-9 months) did not demonstrate improvement that reached significance. Some have misinterpreted CPASS results to indicate that all inpatient motor therapy should be shifted to outpatient therapy delivered 2 to 3 months post-stroke. Instead, however, CPASS argues for a large dose of motor therapy delivered continuously and cumulatively during the acute and subacute phases.

Methodological Issues in Advancing the Status of Functional Cognitive Assessment.

Many individuals in acute hospital and post-acute care settings experience changes in their capacity to perform complex activities of daily living associated with deficits in functional cognition. Occupational therapists regularly assess and treat these occupational performance deficits. The construct of functional cognition offers oportunities for occupational therapists to define an approach to cognition that is both distinct from that of other disciplines and that supports evidence-based interventions.

Further Validation of the Menu Task: Functional Cognition Screening for Older Adults.

Occupational therapists need a brief tool to identify the potential for functional cognitive deficits leading to impaired occupational performance. The objective is to establish the sensitivity and specificity, concurrent and known-group validity of the Menu Task by comparison with performance on the Weekly Calendar Planning Activity (WCPA). Using a cross-sectional design, we administered the Menu Task and the WCPA to a community-dwelling convenience sample of 287 adults aged from 55 to 93 years.

Cardiorespiratory fitness and cognition in persons at risk for Alzheimer's disease.

Introduction: This study examined the relationship between cardiorespiratory fitness (CRF) and longitudinal cognitive functioning in a cohort enriched with risk factors for Alzheimer's disease (AD).

Methods: A total of 155 enrollees in the Wisconsin Registry for Alzheimer's Prevention completed repeat comprehensive neuropsychological evaluations that assessed six cognitive domains. Peak oxygen consumption (VOpeak) was the primary measure of CRF.

From paper to screen: regulatory and operational considerations for modernizing the informed consent process.

Electronic platforms provide an opportunity to improve the informed consent (IC) process by permitting elements shown to increase research participant understanding and satisfaction, such as graphics, self-pacing, meaningful engagement, and access to additional information on demand. However, including these elements can pose operational and regulatory challenges for study teams and institutional review boards (IRBs) responsible for the ethical conduct and oversight of research. We examined the experience of two study teams at Alzheimer's Disease Research Centers who chose to move from a paper-based IC process to an electronic informed consent (eIC) process to highlight some of these complexities and explore how IRBs and study teams can navigate them.

Perceptions of Research Burden and Retention Among Participants in ADRC Cohorts.

Objectives: Alzheimer disease (AD) and related dementias clinical research is associated with significant participant burden. The Perceived Research Burden Assessment (PeRBA) measures participants' perceptions of logistical, psychological, and physical burdens. The purpose of this study was to assess PeRBA's psychometric properties, perceptual sources, and behavioral consequences with participants in a multisite study of participant retention in longitudinal cohort studies of Alzheimer disease and related dementias.

Retaining Participants in Longitudinal Studies of Alzheimer's Disease.

Background: Retention of study participants is essential to advancing Alzheimer's disease (AD) research and developing therapeutic interventions. However, recent multi-year AD studies have lost 10% to 54% of participants.

Objective: We surveyed a random sample of 443 participants (Clinical Dementia Rating [CDR]≤1) at four Alzheimer Disease Research Centers to elucidate perceived facilitators and barriers to continued participation in longitudinal AD research.

"There's not much we can do…" researcher-level barriers to the inclusion of underrepresented participants in translational research.

Introduction: The lack of diversity in health research participation has serious consequences for science as well as ethics. While there is growing interest in solving the problem, much of the work to date focuses on attitudes of distrust among members of underrepresented communities. However, there is also a pressing need to understand existing barriers within the cultural and structural context of researchers and research staff.

Critical Period After Stroke Study (CPASS): A phase II clinical trial testing an optimal time for motor recovery after stroke in humans.

Restoration of human brain function after injury is a signal challenge for translational neuroscience. Rodent stroke recovery studies identify an optimal or sensitive period for intensive motor training after stroke: near-full recovery is attained if task-specific motor training occurs during this sensitive window. We extended these findings to adult humans with stroke in a randomized controlled trial applying the essential elements of rodent motor training paradigms to humans.

A Framework for Addressing Clients' Functional Cognitive Deficits After COVID-19.

Occupational therapy's focus on functional cognition offers a distinct approach to the assessment of and intervention for occupational performance deficits that may follow coronavirus disease 2019 (COVID-19). Although the majority of people survive COVID-19, many people experience persistent functional cognitive sequelae severe enough to interfere with occupational performance. After COVID-19, people may be categorized as either (1) those who experience severe or critical illness requiring hospitalization or (2) those with mild to moderate presentations of the virus without hospitalization.

Why Are Stroke Rehabilitation Trial Recruitment Rates in Single Digits?

Recruitment of patients in early subacute rehabilitation trials (<30 days post-stroke) presents unique challenges compared to conventional stroke trials recruiting individuals >6 months post-stroke. Preclinical studies suggest treatments be initiated sooner after stroke, thus requiring stroke rehabilitation trials be conducted within days post-stroke. How do specific inclusion and exclusion criteria affect trial recruitment rates for early stroke rehabilitation trials? Provide estimates of trial recruitment based on screening and enrollment data from a phase II early stroke rehabilitation trial.

Screening to Assessment Pathways in Evaluating Functional Cognition in Older Adults.

Identification of functional cognitive deficits can facilitate intervention to improve outcomes among older adults. We aimed to determine if impairments on screening tests of cognition are associated with deficits in performance on a more extensive functional cognitive assessment. Using a cross-sectional study design we administered the Montreal Cognitive Assessment (MoCA), the Mini-Cog, the Menu Task, and Weekly Calendar Planning Activity (WCPA) to a convenience sample of 277 community-dwelling older adults (55-93 years old).

How Well Does the Brief Interview for Mental Status Identify Risk for Cognition Mediated Functional Impairment in a Community Sample?

Objective: To determine the adequacy of the Brief Interview for Mental Status (BIMS) compared with other screening tools in identifying individuals with limitations in functional cognition and instrumental activities of daily living (IADL).

Design: Cross-sectional observational study.

Setting: Midsized midwestern city.

Emotion recognition impairments and social well-being following right-hemisphere stroke.

Accurately recognizing and responding to the emotions of others is essential for proper social communication and helps bind strong relationships that are particularly important for stroke survivors. Emotion recognition typically engages cortical areas that are predominantly right-lateralized including superior temporal and inferior frontal gyri - regions frequently impacted by right-hemisphere stroke. Since prior work already links right-hemisphere stroke to deficits in emotion recognition, this research aims to extend these findings to determine whether impaired emotion recognition after right-hemisphere stroke is associated with worse social well-being outcomes.