Ganesh M. Babulal

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Verified

Ganesh verified their affiliation via an institutional email.

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• PhD, OTD, MSCI, MOT, OTR/L
• Professor (Associate) at Washington University in St. Louis

INTRODUCTION Sociodemographic predictors are established risk factors for Alzheimer's disease (AD), a leading cause of cognitive decline. This study examines the influence of environmental exposures like walkability, green space, and light pollution among older adults. METHODS Cross‐sectional analysis examined associations between walkability, gre...

This paper reports on a Conference organized by the Washington University School of Medicine's (WUSM) Knight Alzheimer Disease Research Center (Knight ADRC), entitled “Enhancing Participation by Minoritized Groups in Alzheimer Disease and Related Dementia (ADRD) Research.” It builds on recommendations from a 2018 Workshop. Representatives from all...

A likely determinant of cognitive function is incarceration. Structural racism directs adverse policing to differentially patrol groups racialized as Black increasing the chances of incarceration, leading to disproportionate representation in prisons. Direct and indirect exposure to incarceration produces chronic stress and trauma for adults racial...

Neuropsychiatric symptoms (NPS) are common throughout the Alzheimer's disease (AD) continuum and profoundly affect patients, caregivers, and health‐care systems. This review synthesizes key research presented in the 2022 and 2023 Alzheimer's Association International Society to Advance Alzheimer's Research and Treatment Neuropsychiatric Syndromes–P...

Background As the fastest-growing segment of the population, adults over 65 are at the most significant risk for Alzheimer's disease (AD). Older adults often use anti-seizure medications (ASMs), which can negatively impact cognitive function, mood, and behavior, mimicking AD or its symptoms. Understanding the effects of ASMs across diverse older ad...

Driving reaction time (DRT) is one of the most important predictors of motor vehicle crashes in older adults. Although individuals with preclinical Alzheimer’s disease (AD) show subtle cognitive changes that may affect driving, their DRT to emergency events has not been investigated. We compared DRT to an emergency event between 19 drivers with pre...

Objective This study classified preclinical Alzheimer’s disease (AD) using cognitive screening, neighborhood deprivation via the Area Deprivation Index (ADI), and sociodemographic and genetic risk factors. Additionally, it compared the predictive accuracy of multiple machine learning algorithms and examined model performance with two bootstrapping...

Inclusion and belonging are fundamental human needs and key to the engagement and well-being of occupational therapy practitioners, scientists, educators, and learners. Despite this, the profession has struggled throughout its history to act on its values as focused on wide-ranging perspectives of occupational engagement in diverse cultural context...

Depression in older adults is often underdiagnosed and has been linked to adverse outcomes, including motor vehicle crashes. With a growing population of older drivers in the United States, innovations in screening methods are needed to identify older adults at greatest risk of decline. This study used machine learning techniques to analyze real-wo...

We examined whether driving behavior can predict preclinical Alzheimer’s disease (AD). Data from 131 cognitively normal older adults with cerebrospinal fluid (CSF) and/or positron emission tomography (PET) biomarkers were examined with naturalistic driving behavior. Receiver operating characteristic curves were used to predict the highest 10%, 25%,...

Neurodegeneration is presumed to be the pathological process measure most proximal to clinical symptom onset in Alzheimer Disease (AD). Structural MRI is routinely collected in research and clinical trial settings. Several quantitative MRI‐based measures of atrophy have been proposed, but their low correspondence with each other has been previously...

Background Alzheimer’s disease (AD) blood tests that can identify and quantify amyloid plaques, tau tangles, and cognitive and clinical decline are needed in clinical practice, including primary care. However, these tests require validation in diverse groups and real‐world settings. The Study to Evaluate Amyloid in Blood and Imaging Related to Deme...

See related article by Ganguli et al .

Background Nearly half the world’s population is bi‐ or multilingual, where diverse interpretations of bilingualism with varying associated sociodemographic factors may lead to inconsistent conclusions in bilingualism and cognitive research and thus our study aimed to further examine this. Method We examined the sociodemographic features and bilin...

Background Trip chaining occurs when a driver departs from an origin and travels to multiple locations before returning. Increased trip complexity may require higher levels of executive function, memory, and navigational abilities. Subtle behavioral changes are apparent before a clinical diagnosis of Alzheimer Disease (AD); however, the corresponde...

Background Seizures, traumatic brain injury (TBI), and dementia increase in prevalence with age. However, the role of seizure and TBI on cognitive impairment risk (CI) is unclear. This study investigated how a diagnosis of seizures and TBI was associated with the progression to CI and assessed the role of medications. Method We analyzed data from...

Importance Depression and antidepressant use are independently associated with crash risk among older drivers. However, it is unclear what factors impact daily driving that increase safety risk for drivers with depression. Objective To examine differences in naturalistic driving behavior and safety between older adults with and without major depre...

Background The aging population in the USA is projected to increase significantly, with a corresponding rise in dementia cases, particularly among racial minorities. This study examines the key drivers of racial disparities in dementia risk among older Black adults in the St. Louis area, a region characterized by entrenched structural racism. Utili...

Frontotemporal dementia (FTD) is one of the leading causes of young‐onset dementia before age 65, typically manifesting as abnormal behavior (in behavioral variant FTD) or language impairment (in primary progressive aphasia). Although FTD affects all populations across the globe, knowledge regarding the pathophysiology and genetics derives primaril...

Background The significant increase in Alzheimer’s disease and related dementia prevalence is a global health crisis, acutely impacting low- and lower-middle and upper-middle-income countries (LLMICs/UMICs). Objective The objective of this study is to identify key barriers and gaps in dementia care and research in LLMICs and UMICs. Methods We con...

Objectives: Examine whether physical activity (PA) changes during the COVID-19 pandemic were related to subjective cognitive decline (SCD), depression, and anxiety in older adults and whether these varied by sociodemographic variables. Methods: 301 older adults completed an online survey between May and October 2020 and 3 months later, including se...

Introduction: Alzheimer disease (AD) has a long preclinical phase in which AD pathology is accumulating without detectable clinical symptoms. It is critical to identify participants in this preclinical phase as early as possible since treatment plans may be more effective in this stage. Monitoring for changes in driving behavior, as measured with...

Importance Traumatic brain injury (TBI), seizures, and dementia increase with age. There is a gap in understanding the associations of TBI, seizures, and medications such as antiseizure and antipsychotics with the progression of cognitive impairment across racial and ethnic groups. Objective To investigate the association of TBI and seizures with...

Background Neuropsychiatric symptoms (NPS) can be an early manifestation of Alzheimer’s disease (AD). However, the associations among NPS, cognition, and AD biomarkers across the disease spectrum are unclear. Objective We analyzed cross-sectional mediation pathways between cerebrospinal fluid (CSF) biomarkers of AD (Aβ1-42, p-tau181), cognitive fu...

Blood-based biomarkers of Alzheimer disease (AD) may facilitate testing of historically under-represented groups. The Study of Race to Understand Alzheimer Biomarkers (SORTOUT-AB) is a multi-center longitudinal study to compare AD biomarkers in participants who identify their race as either Black or white. Plasma samples from 324 Black and 1,547 wh...

Maintaining driving independence is important for older adults. However, cognitive decline, a common issue in older populations, can impair older adults’ driving abilities and overall safety on the roads. This study explores how cognitive impairment influences driving patterns and driving choices among older adults. We analyzed real-world driving p...

INTRODUCTION This ongoing, prospective study examines the effectiveness of methods used to successfully recruit and retain 238 Black older adults in a longitudinal, observational Alzheimer's disease (AD) study. METHODS Recruitment strategies included traditional media, established research registries, speaking engagements, community events, and sn...

We investigate Alzheimer's disease and related dementia (ADRD) prevalence, incidence rate, and risk factors in individuals racialized as Asian and/or Asian‐American and assess sample representation. Prevalence, incidence rate, risk factors, and heterogeneity of samples were assessed. Random‐effects meta‐analysis was conducted, generating pooled est...

Background and Objectives: With the aging US population and increasing incidence of Alzheimer disease (AD), understanding factors contributing to driving cessation among older adults is crucial for clinicians. Driving is integral for maintaining independence and functional mobility, but the risk factors for driving cessation, particularly in the co...

Dementia research lacks appropriate representation of diverse groups who often face substantial adversity and greater risk of dementia. Current research participants are primarily well‐resourced, non‐Hispanic White, cisgender adults who live close to academic medical centers where much of the research is based. Consequently, the field faces a knowl...

Background and Objectives Multidimensional poverty is associated with dementia. We aimed at establishing this association in Pakistan. Research Design and Methods A cross-sectional study was conducted in Punjab and Sindh, Pakistan, between March 30, 2002, and August 22, 2022, among adults aged 50 and older. Multidimensional poverty measures were c...

Food insecurity persists in Afghanistan, with 24 million Afghans lacking sufficient food in 2022. Malnourishment affects over 7 million children and mothers (WFP in Afghan Emergency. Retrieved 1.30 from https://www.wfp.org/emergencies/afghanistan-emergency). Women's rights have been severely undermined by the Taliban regime, with bans on education...

Objective This study was undertaken to evaluate the frequency of modifiable dementia risk factors and their association with cognitive impairment and rate of decline in diverse participants engaged in studies of memory and aging. Methods Modifiable dementia risk factors and their associations with cognitive impairment and cognitive decline were de...

Background Low‐and‐middle‐income countries (LMICs) face a crisis with a higher prevalence of dementia and cognitive impairment. It is projected that 68% of dementia cases worldwide will reside in LMICs in 2050. This differential risk is exacerbated by social and environmental determinants of health (SEDOH) and in settings with war, class division,...

Background Preclinical Alzheimer’s disease (AD) may have a subtle functional signature reflected in changes in everyday driving behaviour. Driving has the potential to serve as a digital marker for AD when captured continuously and characterized accurately. This study directly compares the diagnostic performance of digital markers of everyday drivi...

Background Alzheimer’s disease (AD) blood tests are needed to aid in the evaluation of dementia, but the performance of these tests should be evaluated in diverse groups and real‐world settings. The goals of the Study to Evaluate Amyloid in Blood and Imaging Related to Dementia (SEABIRD) were to enroll 1120 participants to determine the participant...

Background Ethno‐racial differences are observed in amyloid (A), tau (T), and neurodegeneration (N) plasma biomarkers of Alzheimer’s disease (AD). In neuroimaging studies, structural and social determinant of health (SSDOH) factors and associated health outcomes may mediate observed racial differences in neurodegeneration markers. However, little i...

Background The pathophysiological process of Alzheimer’s disease (AD) spans approximately 10‐15 years. To define AD by its pathologic processes, the A/T/N classification framework was proposed constituting ß‐amyloid (A), tau (T), and neurodegeneration (N) biomarkers derived from cerebrospinal fluid (CSF) or imaging. With these biomarkers, individua...

Background Driving is an important aspect of independence for older adults. However, cognitive decline may impair driving abilities and safety. A deeper understanding of the impact of cognitive impairment on driving behaviours in older adults can inform public health strategies to support maintaining their ability to drive safely. This study invest...

Background The pathophysiological process of Alzheimer’s disease (AD) spans approximately 10‐15 years. To define AD by its pathologic processes, the A/T/N classification framework was proposed constituting β‐amyloid (A), tau (T), and neurodegeneration (N) biomarkers derived from cerebrospinal fluid (CSF) or imaging. With these biomarkers, individua...

Aging populations in low‐ and middle‐income countries (LMICs) are growing more rapidly than those in high income countries (HICs). Thus, globally, the burden of Alzheimer’s disease and related dementias (ADRD) profoundly impacts LMICs, with greater burden and risk for late‐life women than men. LMICs are unable to meet diagnostic challenges with und...

Objective Daily driving behavior is ultimate measure of cognitive functioning requiring multiple cognitive domains working synergistically to complete this complex instrumental activity of daily living. As the world’s population continues to grow and age older, motor vehicle crashes become more frequent. Cognitive and brain reserve are developing c...

Eighty-eight million Americans will be age 65 or older by 2050 and 25% of all drivers will be ≥ 65 years old. Technology has the potential to address some issues such as the inability to drive in advanced age. We postulate that continuing to drive with the use of Advanced Driver Assistance Systems (ADAS) and/or maintaining social connectedness with...

Objective Subjective cognitive decline (SCD), the self-reported experience of worsening cognitive abilities (Jessen et al., 2014), is associated with increased risk of developing Alzheimer’s disease and Mild Cognitive Impairment. Modifiable factors such as purpose in life (PiL), the experience of living a meaningful life where one’s life goals are...

Objective Physical inactivity is associated with a greater risk of frailty, neuropsychiatric symptoms, worse quality of life, and increased risk for Alzheimer’s disease. Little is known about how physical activity engagement of older adults during the COVID-19 pandemic relates to subjective cognitive concerns and management of emotional distress. T...

Road diets (that is, the reallocation of one or more lanes of car traffic to other uses) have been proposed as a modification to increase pedestrian safety, particularly for older adults. We considered the impacts of road diets on aging drivers, and on those with early pathological accumulation of AD. We observed naturalistic driving data for 60 co...

Importance Older adults are increasingly prescribed medications that have adverse side-effects. Prior studies have found higher risks associated with motor vehicle crashes. Objective: This 10-year study determined whether specific medication classes were associated with performance decline assessed by a standardized road test in a community-sample...

Objective: The use of blood-based biomarkers of Alzheimer disease (AD) may facilitate access to biomarker testing of groups that have been historically under-represented in research. We evaluated whether plasma Aβ42/40 has similar or different baseline levels and longitudinal rates of change in participants racialized as Black or White. Methods: Th...

Importance Older adults are increasingly prescribed medications that have adverse effects. Prior studies have found a higher risk of motor vehicle crashes to be associated with certain medication use. Objective To determine whether specific medication classes were associated with performance decline as assessed by a standardized road test in a com...

Background Declines in instrumental activities of daily living like driving are hallmarks sequelae of Alzheimer’s disease (AD). Although driving has been shown to be associated with traditional imaging and cerebrospinal fluid (CSF) biomarkers, it is possible that some biomarkers have stronger associations with specific aspects of driving behavior....

This JAMA Insights reviews the complex driving needs of older individuals and how clinicians can help address these needs, including recommending use of supplemental technology, assessing fitness to drive, and reviewing medications that may impair driving ability.

The driving populace of the United States is aging. The prevalence of Alzheimer disease (AD) will increase in the coming decades. Road diets (that is, the reallocation of one or more lanes of car traffic to other uses) have been proposed as a modification to increase pedestrian safety, particularly for older adults. In contrast, we considered the i...

Background: Black/African Americans experience a high burden of Alzheimer disease and related dementias yet are critically underrepresented in corresponding research. Understanding barriers and facilitators to research participation among younger and older African Americans is necessary to inform age-specific strategies to promote equity in studie...

Objectives: To investigate the effect of neuropsychiatric symptoms and depression symptoms, respectively, and Alzheimer disease (AD) biomarkers (cerebrospinal fluid [CSF] or Positron Emission Tomography [PET] imaging) on the progression to incident cognitive impairment among cognitively normal older adults. Design: Prospective, observation, long...

Background The COVID‐19 pandemic has impacted daily life worldwide, with possible negative consequences for cognitive health. Self‐reported cognitive symptoms are linked to the development of Alzheimer’s disease and related dementias (ADRDs). Identifying risk and protective factors for cognitive symptoms during the pandemic is an important step tow...

Frontotemporal dementia (FTD) is one of the leading causes of dementia before age 65 and often manifests as abnormal behavior (in behavioral variant FTD) or language impairment (in primary progressive aphasia). FTD’s exact clinical presentation varies by culture, language, education, social norms, and other socioeconomic factors; current research a...

Obesity, depression and Alzheimer's disease (AD) are three major interrelated modern health conditions with complex relationships. Early-life depression may serve as a risk factor for AD, while late-life depression may be a prodrome of AD. Depression affects approximately 23% of obese individuals, and depression itself raises the risk of obesity by...

Introduction: Individuals living in rural communities are at heightened risk for Alzheimer's disease and related dementias (ADRD), which parallels other persistent place-based health disparities. Identifying multiple potentially modifiable risk factors specific to rural areas that contribute to ADRD is an essential first step in understanding the...

INTRODUCTION: Individuals living in rural communities are at heightened risk for Alzheimer’s disease and related dementias (ADRD), which parallels other persistent place-based health disparities. Identifying multiple potentially modifiable risk factors specific to rural areas that contribute to ADRD is an essential first step in understanding the c...

INTRODUCTION: Alzheimer’s disease (AD) blood tests are likely to become increasingly important in clinical practice, but they need to be evaluated in diverse groups before use in the general population. METHODS: This study enrolled a community-based sample of older adults in the St. Louis, Missouri, USA area. Participants completed a blood draw, Ei...

INTRODUCTION: The projected growth of Alzheimer’s disease (AD) and AD-related dementia (ADRD) cases by midcentury has expanded the research field and impelled new lines of inquiry into structural and social determinants of health (S/SDOH) as fundamental drivers of disparities in AD/ADRD. METHODS: In this review, we employ Bronfenbrenner’s ecologic...

Introduction: Health disparities arise from biological-environmental interactions. Neuroimaging cohorts are reaching sufficiently large sample sizes such that analyses could evaluate how the environment affects the brain. We present a practical guide for applying geospatial methods to a neuroimaging cohort. Methods: We estimated brain age gap (BAG...

Background Multidimensional poverty is associated with dementia, but no evidence is available for countries in conflict. Methods A cross-sectional study was conducted in two provinces of Afghanistan between February 15th 2022 and April 20th 2022 among adults age 50 and older. Multidimensional poverty included six dimensions of well-being and 16 in...

In order to increase engagement in physical activity, it is important to determine which factors contribute to physical activity engagement in older adults. The current study examined the relative predictive ability of several potential determinants, in terms of both the concurrent level as well as longitudinal trajectories. Clinically normal adult...

Background Driving behavior as a digital marker and recent developments in blood-based biomarkers show promise as a widespread solution for the early identification of Alzheimer’s disease (AD). Objective This study used artificial intelligence methods to evaluate the association between naturalistic driving behavior and blood-based biomarkers of A...

Background: Cerebral small vessel disease (CSVD) as measured by cortical atrophy and white matter hyperintensities [leukoaraiosis], captured via magnetic resonance imaging (MRI) are increasing in prevalence due to the growth of the aging population and an increase in cardiovascular risk factors in the population. CSVD impacts cognitive function an...

Background: The burden of Alzheimer’s disease and related dementia (ADRD) is projected to disproportionally impact low-middle-income countries (LMICs). However, there is a systematic under-representation of LMICs in ADRD clinical trial platforms. Methods: We aimed to determine the global distribution of ADRD clinical trials and identify existing b...

Introduction: Neuropsychiatric symptoms (NPS) are a risk factor for dementia; however, their prevalence and severity among ethnoracial groups are poorly understood. Methods: We used data from the National Alzheimer’s Coordinating Center (NACC) (n=6958;≥50 years old). Cognitively normal participants at baseline, without any NPS or dementia diagnosi...

INTRODUCTION Alzheimer’s disease (AD) blood tests are likely to become increasingly important in clinical practice, but need to be evaluated in diverse groups before use in the general population. METHODS This study enrolled a community-based sample of older adults in the Saint Louis, Missouri, USA area. Participants completed a blood draw, AD8® d...

Background: Neuroimaging reveals structural brain changes linked with HIV infection and related neurocognitive disorders; however, group-level comparisons between people with HIV and people without HIV do not account for within-group heterogeneity. The aim of this study was to quantify the effects of comorbidities such as cardiovascular disease an...

Older adults are living longer in the United States and the proportion of those belonging to minoritized groups is growing. The value and characteristics of quality of life (QoL) at an older age have becoming of central concern to policy makers. To investigate the wicked problem of ageing and QoL, we conducted and compared two group model building...

Daily driving is a multi-faceted, real-world, behavioral measure of cognitive functioning requiring multiple cognitive domains working synergistically to complete this instrumental activity of daily living. As the global population of older adult continues to grow, motor vehicle crashes become more frequent among this demographic. Cognitive reserve...

The COVID‐19 pandemic has increased psychological distress. Research shows that physical activity can reduce emotional distress and improve cognitive functioning. Yet, the pandemic has limited opportunities to engage in physical activity. In this study, we examined whether older adults who maintained physical activity during the pandemic perceived...

Previous work indicates that imaging and cerebrospinal fluid (CSF) amyloid and tau biomarkers are associated with driving behaviors, and that driving behaviors can be used to identify preclinical Alzheimer’s disease (AD). Along with traditional biomarkers, we examined the extent to which newer plasma and CSF biomarker are related to driving and cog...

Identifying individuals with Alzheimer disease (AD) pathology a decade or more before the onset of dementia symptoms can be achieved with amyloid positron emission tomography (PET), cerebrospinal fluid (CSF) biomarkers, or blood biomarkers. This study compares driving behavior with CSF and blood biomarkers to identify amyloid deposition in AD, as d...

To generalize safety and efficacy findings, it is essential that diverse populations are well represented in global Alzheimer’s disease (AD) drug trials. In this review, we aimed to 1) investigate participant diversity in disease‐modifying AD trials over time, 2) identify which eligibility criteria were used and how they were defined, and 3) how th...

Aging and dementia researchers continue to face challenges in recruiting and retaining participants who represent demographically diverse communities. This continued and critical lack of representation threatens the generalizability and applicability of countless study findings and severely diminishes the field’s impact on clinical outcomes. Recrui...

Researchers working on studies of dementia in Latin American and Caribbean (LAC) countries encounter numerous challenges, in particular, access to financial resources due to limited funding and operational barriers which limit the possibility of recruiting a diverse cohort from the LAC. Addressing challenges to access research is important to ensur...

In the absence of clinically meaningful disease‐modifying treatments, the number of adults with dementia worldwide is projected to more than triple. Much of this increase will occur in low and middle‐income countries (LMICs); by 2050, 68% of adults living with dementia will be in LMICs. However, there is a gross under‐representation of LMICs in his...

Background Multidimensional poverty is associated with chronic health conditions. However, limited research exists investigating the association between multidimensional poverty and dementia on a population level in low‐and middle‐income countries (LMICs). Method This study was conducted in Soweto between 11 November 2019 and 28 February 2020. Par...

Introduction: We investigated the relationship between preclinical Alzheimer's disease (AD) biomarkers and adverse driving behaviors in a longitudinal analysis of naturalistic driving data. Methods: Naturalistic driving data collected using in-vehicle dataloggers from 137 community-dwelling older adults (65+) were used to model driving behavior...

Subjective cognitive decline (SCD), which precedes Mild Cognitive Impairment and dementia, may be affected by purpose in life (PiL) and loneliness in older adults. We investigated associations among PiL, loneliness, and SCD in US Latino ( n = 126), Black ( n = 74), Asian ( n = 33), and White ( n = 637) adults. Higher PiL predicted lower SCD in all...

Objectives To determine the extent to which cognitive domain scores moderate change in driving behavior in cognitively healthy older adults using naturalistic (GPS based) driving outcomes and to compare against self-reported outcomes using an established driving questionnaire. Method We analyzed longitudinal naturalistic driving behavior from a sa...

Psychotic phenomena are among the most severe and disruptive symptoms of dementias and appear in 30% to 50% of patients. They are associated with a worse evolution and great suffering to patients and caregivers. Their current treatments obtain limited results and are not free of adverse effects, which are sometimes serious. It is therefore crucial...

The homeless population in the United States is rapidly aging, with a parallel increase in Alzheimer's disease and related dementia (ADRD). During an evolving pandemic that jeopardizes employment and housing, assessing the relationship between ADRD and homelessness is critical since the latter is potentially intervenable. The objective of this stud...

Purpose of review: Causes of health disparities in Alzheimer disease and related dementias (ADRD) in the United States are multifactorial. This article contextualizes health disparities as they relate to the neurodegenerative processes of ADRD. Recent findings: Older adults' life expectancy has increased such that a 65-year-old is expected to li...

A thorough understanding of individual characteristics of older adults during the COVID-19 pandemic is critical for managing the ongoing pandemic course and planning for the future pandemics. Here, we explore the impact of the COVID-19 pandemic on driving, social distancing, protective, and coping behaviors of older adults. This study reports data...

Our objective was to identify functional brain changes that associate with driving behaviors in older adults. Within a cohort of 64 cognitively normal adults (age 60+), we compared naturalistic driving behavior with resting state functional connectivity using machine learning. Functional networks associated with the ability to interpret and respond...

Sex or gender differences in the risk of Alzheimer's disease and related dementias (ADRD) differ by world region, suggesting that there are potentially modifiable risk factors for intervention. However, few epidemiological or clinical ADRD studies examine sex differences; even fewer evaluate gender in the context of ADRD risk. The goals of this per...

Importance: Limited research exists investigating the association between multidimensional poverty and dementia in low-and middle-income countries (LMICs). Objective: To investigate the association between multidimensional poverty and dementia among adults aged 50 years or older living in South Africa. Design, setting, and participants: This c...