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. Participants: Of the 72 participants enrolled in CPASS (N=72), 53 were in the study groups eligible to receive the treatment initiated at ≤30 days (acute), 2-3 months (subacute), or ≥6 months (chronic) poststroke. Individuals were 65.1±10.5 years of age, 55% were women, and had mild to moderate UE motor capacity (Action Research Arm Test=17.2±14.3) at baseline. Intervention: The additional 20 hours of treatment began using the Activity Card Sort (ACS), a standardized assessment of activities and participation after stroke, to identify UE treatment goals selected by the participants that were meaningful to them. Treatment activities were broken down into smaller components from a standardized protocol and process that operationalized the treatments essential elements. Main Outcome Measures: Feasibility of performing the treatment in a variety of clinical settings in an RCT and contextual factors that influenced adherence. Results: A total of 49/53 participants fully adhered to the CPASS treatment. The duration and location of the treatment sessions and the UE activities practiced during therapy are presented for the total sample (n=49) and per study group as an assessment of feasibility and the contextual factors that influenced adherence. Conclusions: The CPASS treatment and therapy goals were explicitly based on the meaningful activities identified by the participants using the ACS as a treatment planning tool. This approach provided flexibility to customize UE motor therapy without sacrificing standardization or quantification of the data regardless of the location and UE impairments of participants within the first year poststroke.

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. Methods: We analyzed Rouleau and CDIS scores of 310 community-dwelling older adults who had MoCA scores of 20 or above. For each scale we computed Cronbach's alpha, receiver operating characteristic curves (ROC) for sensitivity and specificity using the MoCA as the index measure, and item response theory models for difficulty level. Results: Our sample was 75% female and 85% Caucasian with a mean education of 16 years. The Rouleau scale had excellent interrater reliability (94%), poor internal consistency [0.37 (0.48)], low sensitivity (0.59) and moderate specificity (0.71) at a score of 9. The CDIS scale had good interrater reliability (88%), moderate internal consistency [0.66 (0.09)], moderate sensitivity (0.78) and low specificity (0.45) at a score of 19. In the item response models, both scales' total scores gave the most information at lower cognitive levels. Conclusion: In our community-dwelling sample, the CDIS's psychometric properties were better in most respects than the Rouleau for use as a screening instrument. Both scales provide valuable information to clinicians screening older adults for cognitive change, but should be interpreted in the setting of a global cognitive battery and not as stand-alone instruments.

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. METHODS: Reasons for participation were analyzed with factor analysis and regression analysis. Effects of complaints and goal fulfillment on attendance were estimated with fractional logistic models. Open-ended responses were characterized with a Latent Dirichlet Allocation topic model. RESULTS: Study partners participated for personal benefit and altruism. They emphasized personal benefits more when their participants had a CDR > 0 than when they had a CDR = 0. This difference declined with participant age. The majority of study partners rated their ADRC participation as positive and meeting their goals. Although half reported at least one complaint, very few regretted participating. Those who reported that ADRC participation fulfilled their goals or had fewer complaints were more likely to have perfect attendance. Study partners requested more feedback about test results and better management of study visits. CONCLUSION: Study partners are motivated by both personal and altruistic goals. The salience of each goal depends on their trust in researchers and the participant's cognitive status and age. Retention may improve with perceived goal fulfillment and fewer complaints. Potential areas for improving retention are providing more information about the participant's test results and better management of study visits.

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. The COVID-19 pandemic highlighted how exclusion of representative populations in research can increase health inequities. We applied findings of this meeting to perform a literature review of barriers and solutions to recruitment and retention of representative populations in research and to discuss how findings are important to research conducted during the ongoing COVID-19 pandemic. We highlight the role of SDOH, review barriers and solutions to underrepresentation, and discuss the importance of a structural competency framework to improve research participation and retention among special populations.

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. When interpreting trials like CPASS, one must consider the substantial dose of early usual customary care (UCC) motor therapy that all participants received. CPASS participants averaged 27.9 hours of UCC occupational therapy (OT) during the first 2 months and 9.8 hours of UCC OT during the third and fourth months post-stroke. Any recovery experienced would therefore result not just from CPASS intensive motor therapy but the combined effects of experimental therapy plus UCC. Statistical limitations also did not allow direct comparisons of the acute and subacute group outcomes in CPASS. Instead of shifting inpatient therapy hours to the subacute phase, CPASS argues for preserving inpatient UCC. We also recommend conducting multi-site dosing trials to determine whether additional intensive motor therapy delivered in the first 2 to 3 months following inpatient rehabilitation can further improve outcomes.

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. The receiver operating characteristic (ROC) analysis estimated sensitivity and specificity. Concurrent and known-group construct validity was examined by comparing scores on the Menu Task with the WCPA scores. As a result, a new cutoff score of 9 was established for the Menu Task (area under the curve [AUC] = 0.80, sensitivity = 0.89, 95% confidence interval [CI] = [0.73, 0.97]; specificity = 0.58, 95% CI = [0.52, 0.64]). Both concurrent and construct validity were supported. The Menu Task demonstrates sensitivity to functional cognitive impairments in a community sample.

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. DESIGN: Multicenter mixed methods. SETTING: In-person or phone. PARTICIPANTS: A total of 443 participants at 4 NIA-funded Alzheimer Disease Research Centers (ADRCs) were randomly selected and invited to participate if they were 45 years of age or more, enrolled in longitudinal studies, and had a Clinical Dementia Rating Scale global score ≤1. MEASUREMENTS: Participants completed a 20-minute survey including the 21-item PeRBA about their research participation. RESULTS: PeRBA demonstrated high-internal consistency and convergent validity. PeRBA scores correlated with expected perceptual factors. Higher PeRBA scores were associated with lower attendance and higher dropout rates. CONCLUSIONS: PeRBA can be used by researchers to identify participants who may feel overburdened and tailor approaches and strategies to support participants in longitudinal AD studies, maximizing participation, and reducing dropout. Making efforts to increase participants' understanding of study procedures, and building and maintaining trust throughout the study, can contribute to reducing perceived burden and potentially increasing retention in longitudinal AD studies.

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 (VO2peak) was the primary measure of CRF. Random effects regression was used to investigate the effect of CRF on cognitive trajectories. Results: Higher CRF was associated with slower decline in the cognitive domains of verbal learning and memory (P < .01) and visual learning and memory (P < .042). Secondary analyses indicated that these effects were stronger among men than women, and for noncarriers of the apolipoprotein E ε4 allele. Discussion: Higher CRF was associated with a slower rate of the decline in episodic memory that occurs as a natural consequence of aging in a cohort enriched with risk factors for AD.

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. Here, we identify the key regulations that should be considered when developing and using an eIC process as well as some of the operational considerations eIC presents related to IRB review and how they can be addressed.

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. METHODS: Reasons for participation were characterized with factor analysis. Effects of perceived fulfillment of one's own goals and complaints on attendance and likelihood of dropout were estimated with logistic regression models. Open-ended responses suggesting study improvements were analyzed with a Latent Dirichlet Allocation topic model. RESULTS: Factor analyses revealed two categories, personal benefit and altruism, as drivers of continued participation. Participants with cognitive impairment (CDR > 0) emphasized personal benefits more than societal benefits. Participants with higher trust in medical researchers were more likely to emphasize broader social benefits. A minority endorsed any complaints. Higher perceived fulfillment of one's own goals and fewer complaints were related to higher attendance and lower likelihood of dropout. Facilitators included access to medical center support and/or future treatment, learning about AD and memory concerns, and enjoying time with staff. Participants' suggestions emphasized more feedback about individual test results and AD research. CONCLUSION: The results confirmed previously identified facilitators and barriers. Two new areas, improved communication about individual test results and greater feedback about AD research, emerged as the primary factors to improve participation.

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. Stroke patients were adaptively randomized to begin 20 extra hours of self-selected, task-specific motor therapy at ≤30 d (acute), 2 to 3 mo (subacute), or ≥6 mo (chronic) after stroke, compared with controls receiving standard motor rehabilitation. Upper extremity (UE) impairment assessed by the Action Research Arm Test (ARAT) was measured at up to five time points. The primary outcome measure was ARAT recovery over 1 y after stroke. By 1 y we found significantly increased UE motor function in the subacute group compared with controls (ARAT difference = +6.87 ± 2.63, P = 0.009). The acute group compared with controls showed smaller but significant improvement (ARAT difference = +5.25 ± 2.59 points, P = 0.043). The chronic group showed no significant improvement compared with controls (ARAT = +2.41 ± 2.25, P = 0.29). Thus task-specific motor intervention was most effective within the first 2 to 3 mo after stroke. The similarity to rodent model treatment outcomes suggests that other rodent findings may be translatable to human brain recovery. These results provide empirical evidence of a sensitive period for motor recovery in 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. A third group of those who do not have ongoing signs of active infection but who experience new, lasting, or deteriorating symptoms has begun to emerge and may represent a distinct COVID-19 long-haul syndrome. By following the Occupational Therapy Practice Framework and using established processes for occupational therapy assessment and treatment of functional cognition, occupational therapy practitioners can tailor assessments and interventions to meet clients' needs.

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). We created impaired and unimpaired groups using an established cut-off score for each screening test and compared each group on WCPA scores. The WCPA scores that demonstrated significant differences across screening measures were: Accuracy, Efficiency, Strategies, Rules, and Appointments Entered. Effect sizes for the WCPA scores Accuracy and Efficiency were large. Each screening test demonstrated discriminant validity on select WCPA scores and appear to be appropriate for use as screening tests of functional cognition.

Why Are Stroke Rehabilitation Trial Recruitment Rates in Single Digits?

Background: 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? Objectives: Provide estimates of trial recruitment based on screening and enrollment data from a phase II early stroke rehabilitation trial. Methods: CPASS, a phase II intervention trial screened ischemic stroke patients in acute care (18-months, N = 395) and inpatient rehabilitation (22-months, N = 673). Patients were stratified by upper extremity (UE) impairment into mild (NIHSS motor arm = 0, 1); moderate (NIHSS = 2, 3); severe (NIHSS = 4) and numbers of patients disqualified due to CPASS exclusion criteria determined. We also examined if a motor-specific evaluation (Action Research Arm Test, ARAT) increases the pool of eligible patients disqualified by the NIHSS motor arm item. Results: CPASS recruitment in acute care (5.3%) and inpatient rehabilitation (5%) was comparable to prior trials. In acute care, a short stay (7-17-days), prior stroke (13.5% in moderately; 13.2% in severely impaired) disqualified the majority. In inpatient rehabilitation, the majority (40.8%) were excluded for "too mild" impairment. The next majority were disqualified for reaching inpatient rehabilitation "too late" to participate in an early stroke trial (15% in moderately; 24% in severely impaired). Mean ARAT in the "too mild" showed significant impairment and potential to benefit from participation in select UE rehabilitation trials. Conclusions: Screening of ischemic stroke patients while they are still in acute care is crucial to successful recruitment for early stroke rehabilitation trials. A significant proportion of eligible patients are lost to "short length of stay" in acute care, and arrive to inpatient rehabilitation "too late" for an early rehabilitation trial. Additional screening of mildly impaired patients using a motor function specific scale will benefit the trial recruitment and generalizability. Trial Registration Number: http://www.clinicaltrials.gov Identifier: NCT02235974.

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. PARTICIPANTS: We assessed a convenience sample of community dwelling individuals (N=197) aged 55 years and older who were living independently. MAIN OUTCOME MEASURES: Participant scores on the BIMS, Mini-Cog, Menu Task, and Montreal Cognitive Assessment (MoCA) were compared with the Performance Assessment of Self-Care Skills Checkbook Balancing and Shopping tasks (PCST), which are known to predict impairment in complex IADLs associated with a diagnosis of mild cognitive impairment. Multiple logistic regression analyses controlling for participant demographics, as well as sensitivity and specificity, were computed for each screening measure using the PCST as the criterion measure. RESULTS: The Mini-Cog, Menu Task, and MoCA identified 25.89%, 32.49%, and 47.21% more individuals, respectively, as impaired than the BIMS. In multiple logistical regression analyses, the BIMS correctly identified 58% of those impaired on the PCST. However, each of the alternate screening measures correctly identified at least 70% of individuals as impaired on the PCST. CONCLUSIONS: In this community sample, the BIMS was insensitive to subtle impairments with the potential to compromise community living, suggesting that the BIMS may be inappropriate for use outside nursing home settings.

Factors Associated with Lumbar Puncture Participation in Alzheimer's Disease Research.

BACKGROUND: Cerebrospinal fluid (CSF) provides insight into the spectrum of Alzheimer's disease (AD) pathology. While lumbar punctures (LPs) for CSF collection are generally considered safe procedures, many participants remain hesitant to participate in research involving LPs. OBJECTIVE: To explore factors associated with participant willingness to undergo a research LP at baseline and follow-up research study visit. METHODS: We analyzed data from 700 participants with varying cognition (unimpaired, mild cognitive impairment, and dementia) in the Wisconsin Alzheimer's Disease Research Center. We evaluated the relationship of demographic variables (age, sex, race, ethnicity, and years of education) and clinical variables (waist-to-hip ratio, body mass index, AD parental history, cognitive diagnosis) on decision to undergo baseline LP1. We evaluated the relationship of prior LP1 experience (procedure success and adverse events) with the decision to undergo follow-up LP2. The strongest predictors were incorporated into regression models. RESULTS: Over half of eligible participants opted into both baseline and follow-up LP. Participants who underwent LP1 had higher mean education than those who declined (p = 0.020). White participants were more likely to choose to undergo LP1 (p < 0.001); 33% of African American participants opted in compared to 65% of white participants. Controlling for age, education, and AD parental history, race was the only significant predictor for LP1 participation. Controlling for LP1 mild adverse events, successful LP1 predicted LP2 participation. CONCLUSION: Race was the most important predictor of baseline LP participation, and successful prior LP was the most important predictor of follow-up LP participation.

Characterizing upper extremity motor behavior in the first week after stroke.

BACKGROUND: Animal models of brain recovery identify the first days after lesioning as a time of great flux in sensorimotor function and physiology. After rodent motor system lesioning, daily skill training in the less affected forelimb reduces skill acquisition in the more affected forelimb. We asked whether spontaneous human motor behaviors of the less affected upper extremity (UE) early after stroke resemble the animal training model, with the potential to suppress clinical recovery. METHODS: This prospective observational study used a convenience sample of patients (n = 25, mean 4.5 ±1.8) days after stroke with a wide severity range; Controls were hospitalized for non-neurological conditions (n = 12). Outcome measures were Accelerometry, Upper-Extremity Fugl-Meyer (UEFM), Action Research Arm Test (ARAT), Shoulder Abduction/ Finger Extension Test (SAFE), NIH Stroke Scale (NIHSS). RESULTS: Accelerometry indicated total paretic UE movement was reduced compared to controls, primarily due to a 44% reduction of bilateral UE use. Unilateral paretic movement was unchanged. Thus, movement shifted early after stroke; bilateral use was reduced and unilateral use of the non-paretic UE was increased by 77%. Low correlations between movement time and motor performance prompted an exploratory factor analysis (EFA) revealing a 2-component solution; motor performance tests load on one component (motor performance) whereas accelerometry-derived variables load on a second orthogonal component (quantity of movement). CONCLUSIONS: Early after stroke, spontaneous overall UE movement is reduced, and movement shifts to unilateral use of the non-paretic UE. Two mechanisms that could influence motor recovery may already be in place 4.5 ± 1.8 days post stroke: (1) the overuse of the less affected UE, which could set the stage for learned non-use and (2) skill acquisition in the non-paretic limb that could impede recovery. Accurate UE motor assessment requires two independent constructs: motor performance and quantity of movement. These findings provide opportunities and measurement methods for studies to develop new behaviorally-based stroke recovery treatments that begin early after onset.

Protocol of Aerobic Exercise and Cognitive Health (REACH): A Pilot Study.

A growing body of evidence supports that aerobic exercise can decrease the risk of future cognitive impairment and Alzheimer's disease (AD). There is a pressing need to rigorously determine whether cognitively normal yet at-risk individuals stand to benefit from the protective effects of exercise. The present study will test the feasibility of an aerobic exercise intervention in such a population and inform the design of a larger-scale randomized, controlled trial examining the effect of aerobic exercise on biomarkers of AD in late-middle-aged, at-risk individuals. This was a single-site, 1 : 1 block-randomized, parallel, two-arm trial. Cognitively normal participants aged 45-80 with documentation of familial and genetic AD risk factors were randomly assigned to one of two interventions. The Usual Physical Activity group was provided educational materials about exercise. The Enhanced Physical Activity intervention delivered 26 weeks of individualized and supervised aerobic exercise. Exercise duration and intensity were incrementally increased to 150 min/week and 70-80% of heart rate reserve, respectively. Retention and adherence were measured to assess study feasibility. In addition, pre- and post- intervention differences between the two arms were evaluated for cardiorespiratory fitness, physical activity, brain glucose metabolism, cerebral structure, vascular health, memory, executive function, and mood. Data from randomized controlled trials of exercise training are needed to identify the proper exercise prescription for reducing accumulation of AD biomarkers in cognitively normal individuals. The current trial will contribute to filling that gap while informing the design of large-scale trials.

Can Brief Cognitive or Medication Management Tasks Identify the Potential for Dependence in Instrumental Activities of Daily Living?

Background and Objectives: The identification of functional performance deficits is critical to the community independence of older adults. We examined whether a combined cognitive and performance-based medication management measure would be able to better classify an individual's functional cognitive status and potential for instrumental activities of daily living (IADL) impairment than either measure alone. Research Design and Methods: Community-dwelling adults age 55 and older (n = 185) were administered the Mini-Cog, the Medication Transfer Screen-Revised (MTS-R), a combination measure the Medi-Cog-Revised (Medi-Cog-R), the Performance Assessment of Self-Care Skills (PASS) Checkbook Balancing and Shopping tasks (PCST), additional cognitive screening measures, and a self-report daily living scale. Receiver operating characteristic (ROC) curve analyses were computed for the Mini-Cog, MTS-R and the Medi-Cog-R using the PCST performance as the criterion measure. The area under the curve (AUC), sensitivity, and specificity were computed for each measure. Results: The Medi-Cog-R most accurately identified individuals as impaired on the PCST. An AUC statistic of 0.82 for the Medi-Cog-R was greater than either the Mini-Cog (0.75) or the MTS-R (0.73). The Medi-Cog-R demonstrated a sensitivity of 0.71 and a specificity of 0.78 in classifying individuals with impaired IADL as measured by the PCST. Discussion and Implications: The Mini-Cog, the MTS-R, and the Medi-Cog-R all show discriminant validity, but the combined measure demonstrates greater sensitivity and specificity than either component measure alone in identifying IADL impairment. The Medi-Cog-R appears to be a useful screening measure for functional cognition and can be used to prompt further assessment and intervention to promote community independence.

Informed Consent in Two Alzheimer's Disease Research Centers: Insights From Research Coordinators.

Background: Informed consent (IC) is critical to performing ethical research. Unfortunately, the IC process and supporting IC forms are frequently burdensome and do not necessarily meet the informational needs of participants. The intersecting legal and ethical challenges of obtaining IC from individuals with memory or cognitive deficits further exacerbate existing IC shortcomings. For this reason, study coordinators play a critical role in facilitating the IC process in Alzheimer's disease (AD) research. To identify opportunities to improve how IC is obtained in AD research, we examined the IC process from the perspectives of study coordinators at two Alzheimer's Disease Research Centers (ADRC). Methods: We performed semi-structured interviews with 15 study coordinators from two ADRC sites detailing their experience obtaining IC. Interviews were conducted in private, recorded, transcribed, and independently coded using the constant comparative method of grounded theory. Key themes were explored as they emerged. Results: Coordinators reported overall satisfaction with the IC process. However, many reported difficulties maintaining participant attention, explaining complex procedures, and addressing medical misinformation. Although the centers use site-specific consent forms, coordinators at both centers stressed that their IC is too long and the supporting IC forms are too complicated. Coordinators indicated modifying the IC process to the perceived needs of individual participants. Adaptations reported include altering the cadence and vocabulary they employ, using supplemental materials, varying the order of IC topics, and limiting the depth of information presented. Conclusion: A qualitative analysis of interviews with study coordinators reveals opportunities to improve how we obtain IC in AD research. These insights will be used to create an electronic informed consent (eConsent) designed to boost engagement, enhance trust, and improve understanding by supporting participants' direct agency in the IC process.