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Objective: Japanese-Americans are the sixth largest Asian ethnicity in the United States and represent a highly heterogeneous population. Despite representing a large and diverse group, relatively little attention has been paid to clinical best practices for working with this population in the West, particularly for Japanese speakers and issei (first-generation in the United States). This paper offers guidance for providing competent neuropsychological services to Japanese-Americans. Method: Pertinent facets of Japanese culture are presented within the context of the ECLECTIC framework (education and literacy, culture and acculturation, language, economics, communication, testing situation: comfort and motivation, intelligence conceptualization, and context of immigration; Fujii, 2018). The available literature on clinical neuropsychological tests that are translated into Japanese and normed with Japanese samples was reviewed. Results: Specific recommendations for clinicians providing neuropsychological services to Japanese-Americans are presented with an aim of maximizing test fairness by addressing the following issues: comfort with the testing situation, test biases, accessibility, and validity (American Educational Research Association et al., 2014). Additional recommendations for the use of teleneuropsychology; working with geriatric, pediatric, and multiracial populations; and providing useful recommendations and feedback from clinical assessment are provided. Measures that are appropriately translated and/or adapted for use with Japanese populations are presented by cognitive domain to assist clinicians with test selection. Conclusions: This paper provides concrete recommendations for Western neuropsychologists working with patients of Japanese descent in order to address the current gap in cultural competence among clinicians when working with this heterogeneous population. [ABSTRACT FROM AUTHOR]

Background: In addition to measures of cognition, global Alzheimer's disease (AD) clinical trials commonly include measures to assess functional status (activities of daily living; ADLs) and quality of life (QoL) reported by participants and study partners. Most common assessments were validated with North American, White, English‐speaking populations and research suggests that these are not free from cultural and linguistic influence. ADLs and QoL may exhibit regional differences due to socioeconomic and cultural factors. It is important to understand how geo‐cultural factors influence these measures, which are often used as trial efficacy endpoints. In this study, we examined the impact of geo‐cultural region on ADCS‐MCI‐ADL and QoL‐AD when considering baseline cognitive status. Method: This study included electronic ADCS‐MCI‐ADL, QoL‐AD, and ADAS‐Cog data from two multi‐national AD clinical trials of participants with prodromal to mild AD. Data were collected from three geo‐cultural regions: Asia (n = 688); Western Europe (WE; n = 589); and North America (NA; n = 1925). Participants were stratified into five cohorts based on ADAS‐Cog13 scores. Result: QoL‐AD Study Partner and AD Participant scores varied significantly across geo‐cultural regions (Kruskal‐Wallis test; p<0.0001). Both study partner‐reported and participant reported QoL‐AD scores in Asia were lower than scores in NA and WE for all ADAS‐Cog13 cohorts (Dunn's test; p<0.0001). QoL‐AD AD Participant scores in NA and WE did not differ. For participants with lower cognitive performance (ADAS‐Cog > 40th percentile), study partner‐reported QoL‐AD scores in NA were significantly higher than those in WE (Dunn's test; p<0.05), but there was not significant difference on the participant‐reported QoL‐AD scores between these regions. ADCS‐MCI‐ADL scores were not significantly different across groups. Conclusion: Our study found that QoL‐AD, but not ADCS‐MCI‐ADL scores differed significantly across geo‐cultural regions when considering baseline cognitive performance. Both participant and study‐partner reported QoL was lower in Asia than in WE and NA. Cross‐regional differences in QoL may also be moderated by baseline cognitive performance. Different social norms and aging expectation, healthcare resources, and trial participation may have contributed to the regional variance observed. Future studies should examine if specific constructs are more contextually dependent on the local culture. [ABSTRACT FROM AUTHOR]

Background: Alzheimer's disease (AD) clinical trials are increasingly global. Most measures used were validated and standardized with North American, White, English‐speaking populations with limited consideration of cultural nuance. Prior research suggests that both the Clinical Dementia Rating (CDR) and Mini Mental State Examination (MMSE) are not free from cultural and linguistic influence. It is important to understand how geo‐cultural factors influence longitudinal change in scores on these measures, which is often used as the primary endpoint for study efficacy. In this study, we examined whether change in CDR and MMSE scores over one‐year follow‐up varied across geo‐cultural regions. Method: This study included electronic CDR (eCDR) and electronic MMSE (eMMSE) data from four multi‐national AD clinical trials of subjects with prodromal to mild AD. Data were collected at screening and one‐year follow‐up from seven geo‐cultural regions: East Asia (n = 138); Eastern Europe (n = 170); Western Europe (n = 484); North America (n = 496); South America (n = 55); Middle East/Africa (n = 26); and Oceania (n = 26). Result: The Kruskal–Wallis test found statistically significant variance in CDR‐Sum of Box (CDR‐SB) scores across geo‐cultural regions (p <0.0001). Results of the Dunn's test indicated mean change in CDR‐SB scores for South America was significantly lower than those for North America, Eastern Europe, Western Europe, and Mideast/Africa. Additionally, mean change in CDR‐SB scores for East Asia was significantly lower than those for Western and Eastern Europe. Change in MMSE total scores did not vary across geo‐cultural regions. Conclusion: Our study found average change in CDR‐SB but not MMSE total scores differed significantly across geo‐cultural regions. CDR‐SB scores were relatively more stable in South America compared to most other regions, and in East Asia compared to Western/Eastern Europe. The CDR may be more susceptible to cultural factors due to its reliance on subjective information from caregivers, in contrast with the MMSE, a standardized, objective measure. Different social norms and expectations for aging, functional independence, and trial participation in these regions may have contributed to the variance. Future studies should examine if specific CDR or MMSE items are more contextually dependent on the local culture. [ABSTRACT FROM AUTHOR]

Background: The increasingly global scope of clinical trials in Alzheimer's disease (AD) has led to the recruitment of subjects from various geo‐cultural regions. Recent studies suggest that commonly used objective measures of cognition such as the MMSE as well as subjective, clinician‐rated global measures such as the CDR might be impacted by cultural and/or linguistic differences. This raises the question regarding the impact of cultural differences on the convergent validity of the CDR and MMSE. In this analysis, we examined the extent to which the correspondence between the CDR and MMSE varied across seven geo‐cultural regions in multinational AD clinical trials. Method: This study included electronic CDR (eCDR) and electronic MMSE (eMMSE) data from four multinational AD clinical trials of subjects with Prodromal to Mild AD. Data were collected at screening from seven geo‐cultural regions: East Asia (n = 1916), Eastern Europe (n = 1882), South America (n = 1601), Middle East/Africa (n = 188), North America (n = 9311), Oceania (n = 363), and Western Europe (n = 5174). Result: Pearson correlations between eCDR Sum of Boxes (SOB) and eMMSE across the 7 geo‐cultural regions ranged from r = ‐.31 (East Asia, Western Europe) to r = ‐.48 (Mideast/Africa). A linear regression model with geo‐cultural regions entered as covariates further demonstrated that the relationship between eMMSE and eCDR SoB scores differed by region (Adjusted R2 = 0.14, p<0.001). Conclusion: Findings indicate the strength of the correlation between the CDR SOB and MMSE total score varied by geo‐cultural region. These results build on prior findings indicating that CDR SOB and MMSE scores vary across regions independent of each other. A growing body of literature suggests these differences might be due to cultural and/or linguistic factors. [ABSTRACT FROM AUTHOR]

Background: While schizophrenia is observed in different parts of the world across countries, ethnicities, and races, research indicates cultural factors play significant roles in the phenomenology of this illness. Cultural norms and values affect manifestations of this pathology; more specifically, they affect how symptoms are expressed, experienced, and interpreted. Given that culture affects manifestations of schizophrenia, cultural factors should be considered in the assessment of its symptoms in clinical trials. This study explores the differences and patterns in the Positive and Negative Syndrome Scale (PANSS) item ratings across different geocultural regions. Identifying such patterns can give insights into culturally sensitive assessment practices and aid in developing more effective rater training and data surveillance that consider unique cultural factors. Methods: Data were obtained from an international group of raters from 37 different countries, representing 6 geocultural regions across 13 different studies. As part of the rater training and qualification process for each of these studies, raters viewed and scored the 30-item PANSS based on a video-recorded PANSS interview that was administered using the Structured Clinical Interview-Positive and Negative Syndrome Scale (SCI-PANSS). Raters were deemed qualified if their scores fell within the defined acceptable item score ranges. Given the cultural diversity of the raters, the acceptable passing score ranges for each country were determined by a combination of expert opinion scores, group modal scores, and clinical analyses. Only the scores from raters who achieved qualification on their first scoring attempt were analyzed. The number of raters per geocultural regions included: Asia Pacific, n = 397; Eastern Europe, n = 412; Latin America, n = 88; Middle East/Africa, n = 29; North America, n = 339; and Western Europe, n = 129. Results: A Shapiro-Wilk test for normality was conducted on the scores for each PANSS item and found all significantly different from a normal distribution (all ps < .0001). A Kruskal-Wallis test for rank-ordered differences was conducted for each item for the influence of region on item score. Most items showed a significant influence of region on score after a Bonferroni correction was applied; most ps < .0001 with the following exceptions: N1, p < .001; G15, p < .05; P2, P7, N6, N7, G1, G6, G10, G12, and G13 were not significant. The most significant cross-regional differences were found with P1, P3 and P6, and these items were analyzed further with a post hoc Dunn test to understand cross-regional patterns. On P1, Asia Pacific and Eastern Europe were significantly lower than Latin America, North America, and Western Europe (all ps < .0008) but not Mideast/Africa. On P3, Western Europe were significantly lower than all other regions (all ps < .0005); Asia Pacific were significantly lower than Eastern Europe, North America, and Western Europe (all ps < .006). On P6, Asia Pacific and Eastern Europe were significantly lower than all other regions (all ps < .03). Discussion: The present study suggests that ratings of schizophrenia symptoms are influenced by cultural factors. Cultural beliefs and behaviors seem to influence interpretations of schizophrenia pathology. Given that the PANSS is not standardized for cross-cultural contexts, it is important to consider cultural factors when using this scale in clinical studies. In addition, when developing rater training and data surveillance programs, adjustment of acceptable item score ranges for key PANSS items highlighted above for different geocultural region is recommended. Future studies should explore country-level patterning of ratings of the PANSS. [ABSTRACT FROM AUTHOR]

• Subject matter experts were surveyed on how to increase diversity in clinical trials. • Suggested site solutions to diversification include community outreach. • Suggested sponsor support includes incentives and researcher mentoring. It is well recognized that underrepresented and systematically minoritized groups do not have balanced access to clinical trials as study participants or as research Investigators. However, comprehensive data on the perspective of expert clinicians is largely lacking in the current literature. In this pilot exploration, we collected the opinions of 33 subject matter experts (SME) to identify and explore potential barriers to diversification in clinical trials. The majority of respondents live in North America or Central or Western Europe and identified as not a member of an underrepresented or marginalized group (UMB), with about 15% of respondents being a member of a UMB. Overall, about a quarter of respondents reported making an intentional effort to recruit members of UMB as study participants and identified recruitment challenges linked to two areas: psycho-social barriers and practical barriers. A variety of strategies were employed to improve recruitment including engagement with community leaders, targeted advertising, utilizing databases, and social media campaigns. About half of respondents reported difficulties recruiting Investigators from UMB backgrounds, stating culture and language barriers, perceived lack of interest in the field among individuals from UMB, and lack of information as possible reasons for the challenges. [ABSTRACT FROM AUTHOR]