"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). Findings indicate that participants were largely willing to contribute to biobanks but significantly preferred opportunities where they had control over the use of their biological samples through tiered or study-specific forms of consent. Broad consent procedures, although common and perhaps preferred by participants with high trust in researchers, may amount to an exclusionary practice.

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. We examine whether features of the response process-various respondents' behaviors and response quality indicators-are associated with IEPs in a survey with a diverse set of respondents focused on barriers and facilitators to participating in medical research. We also examine whether there are differences in IEPs across respondents' and interviewers' sociodemographic characteristics. Our results show that both respondents' behaviors and response quality indicators predict IEPs, indicating that IEPs reflect what transpires in the interview. In addition, interviewers appear to approach the task of evaluating respondents with differing frameworks, as evidenced by the variation in IEPs attributable to interviewers and associations between IEPs and interviewers' gender. Further, IEPs were associated with respondents' education and ethnoracial identity, net of respondents' behaviors, response quality indicators, and sociodemographic characteristics of respondents and interviewers. Future research should continue to build on studies that examine the correlates of IEPs to better inform whether, when, and how to use IEPs as paradata about the quality of the data obtained.

"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. METHODS: Study participants were African American adults contacted through an AD research registry. We employed a novel method used to create hypothetical research studies varying on a set number of factors. The method is designed to collect potential patterns in decision making regarding research participation but differs from experimental vignette design in that the survey is administered with an accompanying qualitive interview to determine the meaning participants ascribe to factors independently and in conjunction with one another. RESULTS: Sixty-one participants each reviewed three randomly selected research scenarios and created their "ideal" study involving lumbar puncture. Scenario variables included: disclosure of research results, racial and ethnic identity of the researcher, recruitment method, and amount of incentive. CONCLUSION: Findings indicate that transparency in the return of AD research results to be the strongest driver of participation, followed by race of the researcher and amount of incentive. Recruitment method had limited impact on hypothetical decision making.

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

Background. The Menu Task (MT) is an occupational therapy screening measure designed to identify people in need of functional cognitive (FC) assessment. Purpose. To explore whether test-taker strategy selection on the MT is clinically informative. Methods. 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. After MT interviews responses were qualitatively characterized as (a) loss of set (e.g., not recognizing that food preferences are irrelevant to task performance), (b) calorie counting, or (c) planning. Findings. Loss of set was associated with poorer performance on most study measures, calorie counting was associated with superior performance on most study measures, and no differences were observed relating to planning. Implications. Determining the test-takers approach to the MT adds information to that provided by the MT itself.

Exploring the Relationship between Medical Research Literacy and Respondents' Expressed Likelihood to Participate in a Clinical Trial.

Medical research literacy (MRL) is a facet of health literacy that measures a person's understanding of informed consent and other aspects of participation in medical research. While existing research on MRL is limited, there are reasons to believe MRL may be associated with a willingness to participate in medical research. We use data from a racially balanced sample of survey respondents (n = 410): (1) to analyze how MRL scores vary by respondents' socio-demographic characteristics; (2) to examine how MRL relates to respondents' expressed likelihood to participate in a clinical trial; and (3) to provide considerations on the measurement of MRL. The results indicate no differences in MRL scores by race or gender; younger (p < 0.05) and more educated (p < 0.001) individuals have significantly higher MRL scores. Further, higher MRL scores are associated with significantly lower levels of expressed likelihood to participate in a clinical trial. Additionally, the MRL scale included both true and false statements, and analyses demonstrate significant differences in how these relate to outcomes. Altogether, the results signal that further research is needed to understand MRL and how it relates to socio-demographic characteristics associated with research participation and can be measured effectively.

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. This article provides a rationale for performance-based assessment of functional cognition and an overview of the methodological issues associated with the development and implementation of reliable and valid screening and comprehensive asseements of functional.

"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. METHODS: This study adopted a sequential exploratory mixed-methods design to allow for a focused examination of barriers to inclusive research recruitment among researchers and staff. Barriers first identified from an initial quantitative investigation (web-based survey; n = 279) were further explored through qualitative methods (key informant interviews; n = 26). Participants were investigators and research team members in both phases of the study. RESULTS: The survey revealed a paradoxical disconnect between participants' reported belief in the abstract value of diversity in research participation (87.1% important/extremely important) and belief in it as an important goal in their own specific research (38.3% important/extremely important). Interviews reveal that researchers and staff perceive many barriers to the recruitment of members of underrepresented groups and hold a general view of diversity in research as an impractical, even unattainable, goal. CONCLUSIONS: It is crucial that principal investigators not only understand the consequences of the continued exclusion of marginalized groups from research but also implement strategies to reverse this trend and communicate with research staff on the issue. While individual bias does play a role (ex: a priori assumptions about the willingness or ability of members of underrepresented groups to participate), these behaviors are part of a larger context of systemic racism.

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. Eighteen right-hemisphere stroke patients (≥6 months post-stroke) and 21 neurologically healthy controls completed a multimodal emotion recognition test (Geneva Emotion Recognition Test - Short) and reported engagement in social/non-social activities and levels of social support. Right-hemisphere stroke was associated with worse emotion recognition accuracy, though not all patients exhibited impairment. In line with hypotheses, emotion recognition impairments were associated with greater loss of social activities after stroke, an effect that could not be attributed to stroke severity or loss of non-social activities. Impairments were also linked to reduced patient-reported social support. Results implicate emotion recognition difficulties as a potential antecedent of social withdrawal after stroke and warrant future research to test emotion recognition training post-stroke.

Making Functional Cognition a Professional Priority.

Functional cognition is a critical domain of concern for occupational therapy practice. As the health care system moves to assessing value through achievement of quality outcomes, the field of occupational therapy must address the inclusion of functional cognition in evaluation and treatment. Evidence indicates that impaired cognition contributes to risk of hospital readmission and poor overall health outcomes across diagnostic groups. Moreover, expenditure on occupational therapy services that address functional cognition has been shown to lower hospital readmission rates. To improve client outcomes, occupational therapists must consistently screen for and, when appropriate, evaluate and treat functional cognition impairments and consider functional cognition in the discharge planning process. Occupational therapy professionals must make a proactive, coordinated effort to establish the profession's role in evaluating and treating clients' limitations in functional cognition as a means to achieving improved quality care and client outcomes.

The construct validity of a new screening measure of functional cognitive ability: The menu task.

This study evaluated the construct validity of the Menu Task (MT): a new performance-based screening measure of functional cognition. We enrolled 114 community dwelling adults (55 years or older) in the study: all participants completed the MT and four other neuropsychological screening measures. Construct validity was evaluated using a three-step hierarchical regression model with the MT as the dependent variable. Demographic control variables were entered at step 1, followed by the Brief Interview of Mental Status (BIMS), and the Trail Making Test A (TMT A) at step 2, and finally TMT B and the Montreal Cognitive Assessment (MoCA) at step 3. It was hypothesised that measures sensitive to executive functioning (TMT B and MoCA) would significantly explain MT performance after controlling for demographic variables and adding measures of cognitive function to the model, providing additional evidence for construct validity of the MT. All three steps of the model were statistically significant (p < 0.01). Inclusion of measures sensitive to executive function in step 3 explained 30% of variability in MT score (adjusted R2 = 0.30). Our findings provide further empirical support for the construct validity of the MT, and offer implications for the use of the MT in acute and post-acute care settings.

Ipsilesional Mu Rhythm Desynchronization and Changes in Motor Behavior Following Post Stroke BCI Intervention for Motor Rehabilitation.

Loss of motor function is a common deficit following stroke insult and often manifests as persistent upper extremity (UE) disability which can affect a survivor's ability to participate in activities of daily living. Recent research suggests the use of brain-computer interface (BCI) devices might improve UE function in stroke survivors at various times since stroke. This randomized crossover-controlled trial examines whether intervention with this BCI device design attenuates the effects of hemiparesis, encourages reorganization of motor related brain signals (EEG measured sensorimotor rhythm desynchronization), and improves movement, as measured by the Action Research Arm Test (ARAT). A sample of 21 stroke survivors, presenting with varied times since stroke and levels of UE impairment, received a maximum of 18-30 h of intervention with a novel electroencephalogram-based BCI-driven functional electrical stimulator (EEG-BCI-FES) device. Driven by spectral power recordings from contralateral EEG electrodes during cued attempted grasping of the hand, the user's input to the EEG-BCI-FES device modulates horizontal movement of a virtual cursor and also facilitates concurrent stimulation of the impaired UE. Outcome measures of function and capacity were assessed at baseline, mid-therapy, and at completion of therapy while EEG was recorded only during intervention sessions. A significant increase in r-squared values [reflecting Mu rhythm (8-12 Hz) desynchronization as the result of attempted movements of the impaired hand] presented post-therapy compared to baseline. These findings suggest that intervention corresponds with greater desynchronization of Mu rhythm in the ipsilesional hemisphere during attempted movements of the impaired hand and this change is related to changes in behavior as a result of the intervention. BCI intervention may be an effective way of addressing the recovery of a stroke impaired UE and studying neuromechanical coupling with motor outputs. Clinical Trial Registration: ClinicalTrials.gov, identifier NCT02098265.

Reliability and Validity of a Functional Cognition Screening Tool to Identify the Need for Occupational Therapy.

IMPORTANCE: The Centers for Medicare & Medicaid Services (CMS) has identified the need to assess functional cognition as part of the postacute care planning process. OBJECTIVE: We examined the reliability, validity, and clinical utility of the Menu Task (MT) as a screening measure of functional cognition to assess the need for occupational therapy services. DESIGN: Cross-sectional study testing a convenience sample of community-dwelling older adults (n = 130) and adults hospitalized for elective orthopedic surgery (n = 60). The MT and four neuropsychological screening tests-the Brief Interview of Mental Status, the Montreal Cognitive Assessment, Trail Making Tests A and B, and an instrumental activities of daily living (IADL) scale-were administered. SETTING: Community-dwelling participants were tested at the University of Wisconsin occupational therapy program and in community settings. Hospitalized participants were tested at the University of Missouri Orthopedic Institute. PARTICIPANTS: We recruited healthy community-dwelling adults in Madison, WI (community sample; n = 130) and patients hospitalized for elective orthopedic surgery in Columbia, MO (hospital sample; n = 60). Inclusion criteria were age 55 yr or older, living in the community, and willingness to be tested in English; for the hospital sample, participants had to be referred for elective orthopedic surgery requiring a hospital stay and be independent in activities of daily living before being admitted for surgery. RESULTS: We found significant differences between groups classified as impaired or not impaired on the basis of MT scores. Participants classified as impaired on the MT performed significantly less well than those classified as not impaired on the neurocognitive and IADL measures. CONCLUSION: The reliability and validity of the MT were supported. WHAT THIS ARTICLE ADDS: The American Occupational Therapy Association and the occupational therapy experts advising CMS have stressed the importance of a brief performance-based screening tool to identify people who need more comprehensive occupational therapy evaluation. The implementation of a functional cognition screening tool as part of the required CMS assessment protocol should greatly increase the number of patients referred for occupational therapy evaluation and treatment. The MT has the capacity to address the gap in the proposed CMS assessment of Medicare recipients across postacute care settings.

Behavioral Outcomes Following Brain-Computer Interface Intervention for Upper Extremity Rehabilitation in Stroke: A Randomized Controlled Trial.

Stroke is a leading cause of persistent upper extremity (UE) motor disability in adults. Brain-computer interface (BCI) intervention has demonstrated potential as a motor rehabilitation strategy for stroke survivors. This sub-analysis of ongoing clinical trial (NCT02098265) examines rehabilitative efficacy of this BCI design and seeks to identify stroke participant characteristics associated with behavioral improvement. Stroke participants (n = 21) with UE impairment were assessed using Action Research Arm Test (ARAT) and measures of function. Nine participants completed three assessments during the experimental BCI intervention period and at 1-month follow-up. Twelve other participants first completed three assessments over a parallel time-matched control period and then crossed over into the BCI intervention condition 1-month later. Participants who realized positive change (≥1 point) in total ARAT performance of the stroke affected UE between the first and third assessments of the intervention period were dichotomized as "responders" (<1 = "non-responders") and similarly analyzed. Of the 14 participants with room for ARAT improvement, 64% (9/14) showed some positive change at completion and approximately 43% (6/14) of the participants had changes of minimal detectable change (MDC = 3 pts) or minimally clinical important difference (MCID = 5.7 points). Participants with room for improvement in the primary outcome measure made significant mean gains in ARATtotal score at completion (ΔARATtotal = 2, p = 0.028) and 1-month follow-up (ΔARATtotal = 3.4, p = 0.0010), controlling for severity, gender, chronicity, and concordance. Secondary outcome measures, SISmobility, SISadl, SISstrength, and 9HPTaffected, also showed significant improvement over time during intervention. Participants in intervention through follow-up showed a significantly increased improvement rate in SISstrength compared to controls (p = 0.0117), controlling for severity, chronicity, gender, as well as the individual effects of time and intervention type. Participants who best responded to BCI intervention, as evaluated by ARAT score improvement, showed significantly increased outcome values through completion and follow-up for SISmobility (p = 0.0002, p = 0.002) and SISstrength (p = 0.04995, p = 0.0483). These findings may suggest possible secondary outcome measure patterns indicative of increased improvement resulting from this BCI intervention regimen as well as demonstrating primary efficacy of this BCI design for treatment of UE impairment in stroke survivors. Clinical Trial Registration: ClinicalTrials.gov, NCT02098265.

Mentoring Program for Young Adults with Sickle Cell Disease.

Using descriptive case studies, this paper describes a short-term mentoring program using goal attainment scaling for young adults with sickle cell disease (SCD). Two participants received three and seven visits, respectively, before dropping out of the program with no significant change in goal attainment scores. Although the program supported meaningful individualized goals, repeated and cumulative effects of hospitalizations, sickle cell pain episodes, family health issues, unsafe location of residence, and transportation appeared to remain significant barriers for to achieve stated goals. While the value of an individualized, community-based mentoring experience that addresses goal attainment remains unanswered, this project documents the complex and health barriers of young adults living with SCD.

Screening for Functional Cognition in Postacute Care and the Improving Medicare Post-Acute Care Transformation (IMPACT) Act of 2014.

Occupational therapists have a long history of assessing functional cognition, defined as the ability to use and integrate thinking and performance skills to accomplish complex everyday activities. In response to passage of the Improving Medicare Post-Acute Care Transformation (IMPACT) Act of 2014 (Pub. L. 113-185), the American Occupational Therapy Association has been advocating that the Centers for Medicare and Medicaid Services consider functional cognition for inclusion in routine patient assessment in postacute care settings, with important implications for occupational therapy. These efforts have the potential to increase referrals to occupational therapy, emphasize the importance of addressing functional cognition in occupational therapy practice, and support the value of occupational therapy in achieving optimal postacute care outcomes.

Common Sense Model Factors Affecting African Americans' Willingness to Consult a Healthcare Provider Regarding Symptoms of Mild Cognitive Impairment.

OBJECTIVE: Although at increased risk for developing dementia compared with white patients, older African Americans are diagnosed later in the course of dementia. Using the common sense model (CSM) of illness perception, we sought to clarify processes promoting timely diagnosis of mild cognitive impairment (MCI) for African American patients. DESIGN, SETTING, PARTICIPANTS: In-person, cross-sectional survey data were obtained from 187 African American (mean age: 60.44 years). Data were collected at social and health-focused community events in three southern Wisconsin cities. MEASUREMENTS: The survey represented a compilation of published surveys querying CSM constructs focused on early detection of memory disorders, and willingness to discuss concerns about memory loss with healthcare providers. Derived CSM variables measuring perceived causes, consequences, and controllability of MCI were included in a structural equation model predicting the primary outcome: Willingness to discuss symptoms of MCI with a provider. RESULTS: Two CSM factors influenced willingness to discuss symptoms of MCI with providers: Anticipation of beneficial consequences and perception of low harm associated with an MCI diagnosis predicted participants' willingness to discuss concerns about cognitive changes. No association was found between perceived controllability and causes of MCI, and willingness to discuss symptoms with providers. CONCLUSIONS: These data suggest that allaying concerns about the deleterious effects of a diagnosis, and raising awareness of potential benefits, couldinfluence an African American patient's willingness to discuss symptoms of MCI with a provider. The findings offer guidance to designers of culturally congruent MCI education materials, and healthcare providers caring for older African Americans. .

Changes in functional connectivity correlate with behavioral gains in stroke patients after therapy using a brain-computer interface device.

Brain-computer interface (BCI) technology is being incorporated into new stroke rehabilitation devices, but little is known about brain changes associated with its use. We collected anatomical and functional MRI of nine stroke patients with persistent upper extremity motor impairment before, during, and after therapy using a BCI system. Subjects were asked to perform finger tapping of the impaired hand during fMRI. Action Research Arm Test (ARAT), 9-Hole Peg Test (9-HPT), and Stroke Impact Scale (SIS) domains of Hand Function (HF) and Activities of Daily Living (ADL) were also assessed. Group-level analyses examined changes in whole-brain task-based functional connectivity (FC) to seed regions in the motor network observed during and after BCI therapy. Whole-brain FC analyses seeded in each thalamus showed FC increases from baseline at mid-therapy and post-therapy (p < 0.05). Changes in FC between seeds at both the network and the connection levels were examined for correlations with changes in behavioral measures. Average motor network FC was increased post-therapy, and changes in average network FC correlated (p < 0.05) with changes in performance on ARAT (R (2) = 0.21), 9-HPT (R (2) = 0.41), SIS HF (R (2) = 0.27), and SIS ADL (R (2) = 0.40). Multiple individual connections within the motor network were found to correlate in change from baseline with changes in behavioral measures. Many of these connections involved the thalamus, with change in each of four behavioral measures significantly correlating with change from baseline FC of at least one thalamic connection. These preliminary results show changes in FC that occur with the administration of rehabilitative therapy using a BCI system. The correlations noted between changes in FC measures and changes in behavioral outcomes indicate that both adaptive and maladaptive changes in FC may develop with this therapy and also suggest a brain-behavior relationship that may be stimulated by the neuromodulatory component of BCI therapy.

Association of chronic kidney disease with cerebral microbleeds in patients with primary intracerebral hemorrhage.

BACKGROUND AND PURPOSE: To investigate the relationship between chronic kidney disease (CKD) and MRI-defined cerebral microbleeds (CMB), a harbinger of future intracerebral hemorrhage (ICH), among patients with a recent history of primary ICH. METHODS: Using data from a predominantly black cohort of patients with a recent ICH-enrolled in an observational study between September 2007 and June 2011, we evaluated the association between CKD (defined as estimated low glomerular filtration rate<60 mL/min per 1.73 m(2)) and CMB on gradient-echo MRI. Multivariable models were generated to determine the contribution of CKD to the presence, number, and location of CMB. RESULTS: Of 197 subjects with imaging data, mean age was 59 years, 48% were women, 73% were black, 114 (58%) had ≥1 CMBs, and 52 (26%) had CKD. Overall, CKD was associated with presence of CMB (adjusted odds ratio, 2.70; 95% confidence interval [CI], 1.10-6.59) and number of CMB (adjusted relative risk, 2.04; 95% CI, 1.27-3.27). CKD was associated with CMB presence (adjusted odds ratio, 3.44; 95% CI, 1.64-7.24) and number (adjusted relative risk, 2.46; 95% CI, 1.11-5.42) in black patients, but not CMB presence (adjusted odds ratio, 3.00; 95% CI, 0.61-14.86) or number (adjusted relative risk, 1.03; 95% CI: 0.22-4.89) in non-Hispanic white patients (interactions by race were statistically not significant). CONCLUSIONS: CKD is associated with a greater presence and number of CMB in ICH patients, particularly in patients of black race. Future studies should assess whether low estimated glomerular filtration rate may be a CMB risk marker or potential therapeutic target for mitigating the development of CMB.