Racial differences in parent response to COVID schooling policies.

This paper examines whether school COVID-19 policies influenced enrollment differently by student age and race/ethnicity. Unlike much prior research, we i) analyze enrollments for virtually the entire U.S. public school population for both the 2020-2021 and 2021-2022 school years, ii) compare enrollment trends within districts in order to isolate subgroup heterogeneity from district characteristics, and iii) account for district selection into preferred learning modes. Analyzing data on over 9,000 districts that serve more than 90% of public school students in the United States, we find enrollment responses to COVID policies differed notably. We find that White enrollments declined more than Black, Hispanic, and Asian enrollments in districts that started the 2020-2021 school year virtually, but in districts that started in-person the reverse was true: Non-White enrollments declined more than White enrollments. Moreover, Black, Hispanic, and Asian families responded more than White families to higher COVID-19 death rates in the months preceding the start of the 2021 school year. In 2021-2022, enrollment differences by the previous year's learning mode persisted. Racial/ethnic differences did not vary by whether the district required masking in classrooms. These findings are consistent with the greater risk faced by communities of color during the pandemic and demonstrate an additional source of disparate impact from COVID policies.

Alliance A151945: Accrual and characteristics of adolescent and young adult patients in Alliance trials from 2000 to 2017.

BACKGROUND: Identifying patient- and disease-specific characteristics associated with clinical trial enrollment of adolescents and young adults (AYAs) with cancer may target efforts to improve accrual. METHODS: Alliance for Clinical Trials in Oncology (Alliance) trials opened from January 1, 2000, and closed before January 1, 2018, for common AYA cancers were identified. Proportions of AYAs (aged 18-39 years old) versus non-AYAs (aged ≥40 years old) enrolled by cancer type were summarized by descriptive statistics. Among studies with ≥20 AYAs enrolled, demographic and disease characteristics of AYAs versus non-AYAs were compared with χ2 and Kruskal-Wallis tests. A qualitative review was also conducted of therapeutic trials included in analysis in PubMed through December 31, 2021, that reported AYA-specific survival. RESULTS: Among 188 trials enrolling 40,396 patients, AYAs represented 11% (4468 of 40,396) of accrual. AYA accrual varied by cancer type (leukemia, 23.6%; breast, 9.9%; lymphoma, 14.8%; colorectal, 6.2%; central nervous system, 8.1%; melanoma, 11.8%; sarcoma, 12%). Across ages, the proportion of Black and Hispanic patients enrolled was 1%-10%. Compared to non-AYAs, AYAs in breast and colorectal cancer trials were less likely to be White and more likely to be Hispanic. Disease characteristics differed by age for selected trials. Two trials reported AYA-specific survival, with no significant differences observed by age. CONCLUSIONS: AYA accrual to Alliance trials was comparable to or exceeded population-based, age-specific prevalence estimates for most cancer types. Greater proportional representation of Hispanic and non-White patients among AYAs reflects US demographic trends. The small number of minority patients enrolled across ages underscores the persistent challenge of ensuring equitable access to trials, including for AYAs.

Consensus recommendations for improving the cancer clinical trial matching environment.

Enrollment in cancer clinical trials cannot occur without first successfully identifying trials for which patients are a match based on their clinical characteristics. A lack of onsite matching trials has been identified as the single largest barrier preventing patients from participating in clinical trials. The site-agnostic cancer clinical trial matching environment is a mix of public and private tools and infrastructure that are not designed to work together to facilitate trial matching in an efficient manner. To identify policy and infrastructure solutions that could enable more effective and more frequent use of third-party site-agnostic matching, the American Cancer Society Cancer Action Network held a summit to examine challenges and propose consensus recommendations that could address those challenges. At this 2019 summit, stakeholders in this field examined these barriers and challenges and made a number of policy and infrastructure recommendations to improve the ability of this environment to work in a more coordinated and efficient manner.

Provider motivations and barriers to cancer clinical trial screening, referral, and operations: Findings from a survey.

BACKGROUND: Provider and institutional practices have been shown to have a large impact on cancer clinical trial enrollment. Understanding provider perspectives on screening for trial eligibility is necessary to improve enrollment. METHODS: A questionnaire about incentives, barriers, process tools, and infrastructure related to opening trials and referring patients to onsite and offsite trials was administered to diverse stakeholders, including professional societies, advocacy organizations, and industry networks. Descriptive statistics were used to summarize findings. RESULTS: Overall, 693 responses were received, primarily from physicians (42.7%) and nurses (35.6%) employed at hospital health systems (43.7%) and academic centers (36.5%). Approximately half (49.2%) screened all patients for onsite clinical trials with screening typically done by manual chart review (81.9%). The greatest incentive reported for offering trials was providing the best treatment options for patients (67.7%). Contracting and paperwork (48.5%) were the greatest barriers to opening more onsite trials. Offsite referrals were rare. CONCLUSIONS: Screening for trial eligibility is a largely manual and ad hoc process, with screening and referral to offsite trials occurring infrequently. Administrative and infrastructure barriers commonly prevent sites from opening more onsite trials. These findings suggest that automated trial screening tools built into workflows that screen in a site-agnostic manner could result in more frequent trial eligibility screening, especially for offsite trials. With recent momentum, in part in response to the COVID-19 pandemic, to improve clinical trial efficiencies and broaden access and participant diversity, implementing tools to improve screening and referral processes is timely and essential. PLAIN LANGUAGE SUMMARY: There are many factors that contribute to low adult enrollment in cancer clinical trials, but previous research has indicated that provider and institutional barriers are the largest contributors to low cancer clinical trial enrollment. In this survey, we sought to gain insight into cancer clinical trial enrollment practices from the perspective of health care providers such as physicians and nurses. We found that only approximately half of respondents indicated their institution systematically screens their patients for clinical trials and this process is manual and time consuming. Furthermore, we found that providers infrequently search for and refer patients to clinical trials at other sites. Creating better screening methods could improve enrollment in clinical trials.

How far is too far? Cancer prevention and clinical trial enrollment in geographically underserved patient populations.

Despite dedicated efforts to improve equitable access to cancer care in the United States, disparities in cancer outcomes persist, and geographically underserved patients remain at an increased risk of cancer with lower rates of survival. The critical evaluation of cancer prevention inequities and clinical trial access presents the opportunity to outline novel strategies to incrementally improve bookended access to gynecologic cancer care for geographically underserved patients. Cancer prevention strategies that can be addressed in the rural patient population mirror priorities in the Healthy People 2030 objectives and include increased identification of high risk individuals who may benefit from increased cancer screening and risk reduction, increasing the proportion of people who discuss interventions to prevent cancer, such as HPV vaccination, with their provider, and increasing the proportion of adults who complete evidence based cancer screening. Barriers to accrual to clinical trials for rural patients overlap significantly with the same barriers to obtaining health care in general. These barriers include: lack of facilities and specialized providers; lack of robust health infrastructure; inability to travel; and financial barriers. In this review, we will discuss current knowledge and opportunities to improve cancer prevention initiatives and clinical trial enrollment in geographically underserved populations with a focus on rurality.

Underrepresentation of racial and ethnic minority groups in gynecologic oncology: An analysis of over 250 trials.

OBJECTIVE: To describe the participation of racial and ethnic minority groups (REMGs) in gynecologic oncology trials. METHODS: Gynecologic oncology studies registered on ClinicalTrials.gov between 2007 and 2020 were identified. Trials with published results were analyzed based on reporting of race/ethnicity in relation to disease site and trial characteristics. Expected enrollment by race/ethnicity was calculated and compared to actual enrollment, adjusted for 2010 US Census population data. RESULTS: 2146 gynecologic oncology trials were identified. Of published trials (n = 252), 99 (39.3%) reported race/ethnicity data. Recent trials were more likely to report these data (36% from 2007 to 2009; 51% 2013-2015; and 53% from 2016 to 2018, p = 0.01). Of all trials, ovarian cancer trials were least likely to report race/ethnicity data (32.1% vs 39.3%, p = 0.011). Population-adjusted under-enrollment for Blacks was 7-fold in ovarian cancer, Latinx 10-fold for ovarian and 6-fold in uterine cancer trials, Asians 2.5-fold in uterine cancer trials, and American Indian and Alaska Native individuals 6-fold in ovarian trials. Trials for most disease sites have enrolled more REMGs in recent years - REMGs made up 19.6% of trial participants in 2007-2009 compared to 38.1% in 2016-2018 (p < 0.0001). CONCLUSION: Less than half of trials that published results reported race/ethnicity data. Available data reveals that enrollment of REMGs is significantly below expected rates based on national census data. These disparities persisted even after additionally adjusting for population size. Despite improvement in recent years, additional recruitment of REMGs is needed to achieve more representative and equitable participation in gynecologic cancer clinical trials.

Diversity in randomized clinical trials for peripheral artery disease: a systematic review.

BACKGROUND: Significant race and sex disparities exist in the prevalence, diagnosis, and outcomes of peripheral artery disease (PAD). However, clinical trials evaluating treatments for PAD often lack representative patient populations. This systematic review aims to summarize the demographic representation and enrollment strategies in clinical trials of lower-extremity endovascular interventions for PAD. METHODS: Following the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we searched multiple sources (Medline, EMBASE, Cochrane, Clinicaltrials.gov, WHO clinical trial registry) for randomized controlled trials (RCTs), RCT protocols, and peer-reviewed journal publications of RCTs conducted between January 2012 and December 2022. Descriptive analysis was used to summarize trial characteristics, publication or study protocol characteristics, and the reporting of demographic characteristics. Meta-regression was used to explore associations between demographic characteristics and certain trial characteristics. RESULTS: A total of 2,374 records were identified. Of these, 59 met the inclusion criteria, consisting of 35 trials, 14 publications, and 10 protocols. Information regarding demographic representation was frequently missing. While all 14 trial publications reported age and sex, only 4 reported race/ethnicity, and none reported socioeconomic or marital status. Additionally, only 4 publications reported clinical outcomes by demographic characteristics. Meta-regression analysis revealed that 6% more women were enrolled in non-European trials (36%) than in European trials (30%). CONCLUSIONS: The findings of this review highlight potential issues that may compromise the reliability and external validity of study findings in lower-extremity PAD RCTs when applied to the real-world population. Addressing these issues is crucial to enhance the generalizability and impact of clinical trial results in the field of PAD, ultimately leading to improved clinical outcomes for patients in underrepresented populations. REGISTRATION: The systematic review methodology was published in the International Prospective Register of Systematic Reviews (PROSPERO: CRD42022378304).

Up-front matching: an ongoing recruitment method for prospective observational studies that mimics randomization for selected baseline covariates.

In a prospective observational study (POS) designed to assess the average causal effect of a treatment (e.g. Drug A) compared to a comparator (e.g. Drug B) in the treatment population, enrolling all patients who are assigned to the treatments of interest for follow-up has a potentially large negative impact on the statistical efficiency and bias of the analysis of the outcomes and on the cost of the study. "Up-front matching" is an innovative enrollment method for selecting patients for long-term follow-up among those who have already been assigned to treatment or comparator which uses frequency matching and hence avoids the restrictions of individual matching that other methods have used. To achieve potential statistical and logistical efficiencies in the POS, in up-front matching, a target population is defined based on a retrospective database which then enables selecting populations of patients for follow-up that have desirable statistical properties. In particular, the resulting populations of patients who are enrolled look like the population of treatment patients were randomized to treatment or comparator for the baseline covariates that are used to select patients for follow-up. The method is illustrated in detail for a study designed to assess the effect of injectable antipsychotics versus oral antipsychotics.

Prevalence, perceptions and associated factors of health insurance enrollment among older persons in selected cash grant communities in Ghana: a cross-sectional mixed method.

BACKGROUND: Universal Health Coverage has been openly recognized in the United Nations health-related Sustainable Development Goals by 2030, though missing under the Millennium Development Goals. Ghana implemented the National Health Insurance Scheme programme in 2004 to improve financial access to healthcare for its citizens. This programme targeting low-income individuals and households includes an Exempt policy for older persons and indigents. Despite population ageing, evidence of the participation and perceptions of older persons in the scheme in cash grant communities is unknown. Hence, this paper examined the prevalence, perceptions and factors associated with health insurance enrollment among older persons in cash grant communities in Ghana. METHODS: Data were from a cross-sectional household survey of 400 older persons(60 + years) and eight FGDs between 2017 and 2018. For the survey, stratified and simple random sampling techniques were utilised in selecting participants. Purposive and stratified sampling techniques were employed in selecting the focus group discussion participants. Data analyses included descriptive, modified Poisson regression approach tested at a p-value of 0.05 and thematic analysis. Stata and Atlas-ti software were used in data management and analyses. RESULTS: The mean age was 73.7 years. 59.3% were females, 56.5% resided in rural communities, while 34.5% had no formal education. Two-thirds were into agriculture. Three-fourth had non-communicable diseases. Health insurance coverage was 60%, and mainly achieved as Exempt by age. Being a female [Adjusted Prevalence Ratio (APR) 1.29, 95%CI:1.00-1.67], having self-rated health status as bad [APR = 1.34, 95%CI:1.09-1.64] and hospital healthcare utilisation [APR = 1.49, 95%CI:1.28-1.75] were positively significantly associated with health insurance enrollment respectively. Occupation in Agriculture reduced insurance enrollment by 20.0%. Cited reasons for poor perceptions of the scheme included technological challenges and unsatisfactory services. CONCLUSION: Health insurance enrollment among older persons in cash grant communities is still not universal. Addressing identified challenges and integrating the views of older persons into the programme have positive implications for securing universal health coverage by 2030.

The role of gender in health insurance enrollment among geriatric caregivers: results from the 2022 informal caregiving, health, and healthcare survey in Ghana.

BACKGROUND: Female informal caregivers of older adults experience a higher burden of physical and mental health problems compared to their male counterparts due to the greater intensity of care they provide. This is likely to result in an imbalance in health needs, including health insurance enrollment, between male and female informal caregivers of older adults. However, to date, no study is available on the role of gender in health insurance enrollment among informal caregivers of older adults in Ghana. This study examines the association between gender and health insurance enrollment among informal caregivers of older adults in Ghana. METHODS: Cross-sectional data from the Informal Caregiving, Health, and Healthcare Survey among caregivers of older adults aged 50 years or above (N = 1,853 and mean ages = 39.15 years and 75.08 years of informal caregivers and their care recipients, respectively) in Ghana were analyzed. A binary logit regression model was used to estimate the association between gender and health insurance enrollment. All statistical inferences were made at the 5% significance level. RESULTS: The final Model (3) showed that female informal caregivers were 2.70 times significantly more likely to enrol in a health insurance scheme than their male counterparts (AOR: 2.70, 95% CI: 2.09-3.48, p-value = 0.001). Apart from gender, the results revealed that participants aged 55-64 years (AOR = 2.38, 95%CI: 1.29-4.41, p-value = 0.006), with tertiary education (AOR: 3.62, 95% CI: 2.32-5.66, p-value = 0.001) and living with the care recipients (AOR: 1.50, 95% CI: 1.14-1.98, p-value = 0.003) were significantly more likely to enrol in a health insurance scheme than their counterparts. The findings further showed that those who earned between GH¢1000 and 1999 (US$99.50-198.50) monthly (AOR: 0.70, 95% CI: 0.52-0.95, p-value = 0.022) and were affiliated with African traditional religion (AOR: 0.30, 95%CI: 0.09-0.99, p-value = 0.048) were significantly less likely to enrol in a health insurance scheme than their counterparts. CONCLUSION: Gender was a significant predictor of health insurance enrollment among informal caregivers of older adults. This finding contributes to the empirical debates on the role of gender in health insurance enrollment among informal caregivers of older adults. Policymakers need to develop gender-specific measures to address gender gaps in health insurance enrollment among informal caregivers of older adults in Ghana. Such health policies and programs should consider other significant demographic and socioeconomic factors associated with health insurance enrolment among informal caregivers of older adults in Ghana.

The Social Value Misconception in Clinical Research.

Clinical researchers should help respect the autonomy and promote the well-being of prospective study participants by helping them make voluntary, informed decisions about enrollment. However, participants often exhibit poor understanding of important information about clinical research. Bioethicists have given special attention to "misconceptions" about clinical research that can compromise participants' decision-making, most notably the "therapeutic misconception." These misconceptions typically involve false beliefs about a study's purpose, or risks or potential benefits for participants. In this article, we describe a misconception involving false beliefs about a study's potential benefits for non-participants, or its expected social value. This social value misconception can compromise altruistically motivated participants' decision-making, potentially threatening their autonomy and well-being. We show how the social value misconception raises ethical concerns for inherently low-value research, hyped research, and even ordinary research, and advocate for empirical and normative work to help understand and counteract this misconception's potential negative impacts on participants.

Enrollment and clients' satisfaction with a community-based health insurance scheme: a community-based survey in Northwest Ethiopia.

BACKGROUND: Although the Ethiopian government has implemented a community-based health insurance (CBHI) program, community enrollment and clients' satisfaction have not been well investigated in Gondar Zuria district, Northwest Ethiopia. This study assessed CBHI scheme enrollment, clients' satisfaction, and associated factors among households in the district. METHODS: A community-based cross-sectional survey assessed CBHI scheme enrollment and clients' satisfaction among households in Gondar Zuria district, Northwest Ethiopia, from May to June 2022. A systematic random sampling method was used to select the study participants from eligible households. A home-to-home interview using a structured questionnaire was conducted. Data were analysed using the statistical packages for social sciences version 26. Logistic regression was used to identify variables associated with enrollment and clients' satisfaction. A p-value < 0.05 was considered statistically significant. RESULTS: Out of 410 participants, around two-thirds (64.9%) of the participants were enrolled in the CBHI scheme. Residency status (AOR = 1.38, 95% CI: 1.02-5.32; p = 0.038), time taken to reach a health facility (AOR = 1.01, 95% CI: 1.00-1.02; p = 0.001), and household size (AOR = 0.77, 95% CI: 0.67-0.88; p < 0.001) were significantly associated with CBHI scheme enrollment. Two-thirds (66.5%) of enrolled households were dissatisfied with the overall services provided; in particular, higher proportions were dissatisfied with the availability of medication and laboratory tests (88.7%). Household size (AOR = 1.31, 95% CI: 1.01-2.24; p = 0.043) and waiting time to get healthcare services (AOR = 3.14, 95% CI: 1.01-9.97; p = 0.047) were predictors of clients' satisfaction with the CBHI scheme services. CONCLUSION: Although a promisingly high proportion of households were enrolled in the CBHI scheme, most of them were dissatisfied with the service. Improving waiting times to get health services, improving the availability of medications and laboratory tests, and other factors should be encouraged.

Who enrolls and why? Examining center-specific underlying patterns behind enrollment: a New York City-based traumatic brain injury model systems study.

BACKGROUND: To elucidate the sociodemographic and study factors involved in enrollment in the Traumatic Brain Injury Model System (TBIMS) database, this study examined the effect of a variety of variables on enrollment at a local TBIMS center. METHODS: A sample of 654 individuals from the local TBIMS center was studied examining enrollment by age, gender, race, ethnicity, homelessness status at date of injury, history of homelessness, health insurance status, presence of social support, primary language, consenting in hospital or after discharge, and the need for an interpreter. Binary logistic regression was conducted to identify variables that predict center-based enrollment into TBIMS. RESULTS: Results demonstrated that older age was associated with decreasing enrollment (OR = 0.99, p = 0.01), needing an interpreter made enrollment less likely (OR = 0.33, p < 0.01), being primarily Spanish speaking predicted enrollment (OR = 3.20, p = 0.02), Hispanic ethnicity predicted enrollment (OR = 7.31, p = 0.03), and approaching individuals in the hospital predicted enrollment (OR = 6.94, p < 0.01). Here, OR denotes the odds ratio estimate from a logistic regression model and P denotes the corresponding p-value. CONCLUSIONS: These results can be useful in driving enrollment strategies at this center for other similar TBI research, and to contribute a representative TBI sample to the national database.

Underrepresentation of Non-White Participants in the American Academy of Orthopaedic Surgeons Guidelines for Surgical Management of Knee Osteoarthritis.

BACKGROUND: The aim of this study was to examine the racial and ethnic representation in studies included in the 2015 American Academy of Orthopaedic Surgeons Surgical Management of the Knee Evidence-Based Clinical Practice Guideline relative to their representation of the United States (US). METHODS: The demographic characteristics reported in articles included in the 2015 American Academy of Orthopaedic Surgeons Surgical Management of the Knee Evidence-Based Clinical Practice Guideline were analyzed. The primary outcome of interest was the representation quotient, which is the ratio of the proportion of a racial/ethnic group in the guideline studies relative to their proportion in the US. There were 211 studies included, of which 15 (7%) reported race. There were 35 studies based in the US and 7 of the US-based studies reported race. RESULTS: No US-based studies reported race and ethnicity separately, no studies reported American Indian/Alaska Native participants and no US-based studies reported Asian participants. The representation quotient of US-based studies was 0.66 for Black participants, 0.33 for Hispanic participants, and 1.30 for White participants, which indicates a relative over-representation of White participants compared to national proportions. CONCLUSION: This study illustrated that the evidence base for the surgical management of knee osteoarthritis has been constructed from studies which fail to consider race and ethnicity. Of those US-based studies which do report race or ethnicity, study cohorts do not reflect the US population. These results illustrate a disparity in clinical orthopedic surgical evidence and highlight the need for improved research recruitment strategies.

Enrollment forecast for clinical trials at the portfolio planning phase based on site-level historical data.

An accurate forecast of a clinical trial enrollment timeline at the planning phase is of great importance to both corporate strategic planning and trial operational excellence. The naive approach often calculates an average enrollment rate from historical data and generates an inaccurate prediction based on a linear trend with the average rate. Under the traditional framework of a Poisson-Gamma model, site activation delays are often modeled with either fixed initiation time or a simple random distribution while incorporating the user-provided site planning information to achieve good forecast accuracy. However, such user-provided information is not available at the early portfolio planning stage. We present a novel statistical approach based on generalized linear mixed-effects models and the use of non-homogeneous Poisson processes through the Bayesian framework to model the country initiation, site activation, and subject enrollment sequentially in a systematic fashion. We validate the performance of our proposed enrollment modeling framework based on a set of 25 preselected studies from four therapeutic areas. Our modeling framework shows a substantial improvement in prediction accuracy in comparison to the traditional statistical approach. Furthermore, we show that our modeling and simulation approach calibrates the data variability appropriately and gives correct coverage rates for prediction intervals of various nominal levels. Finally, we demonstrate the use of our approach to generate the predicted enrollment curves through time with confidence bands overlaid.

Importance of sex and gender differences in enrollment and interpretation of stroke clinical trials.

OBJECTIVES: This review aims to reinforce the importance of improving sex balance in preclinical trials and sex and gender diversity and proportional balance in clinical trials enrollment and how this influences interpretation of stroke clinical trials. It also aims to identify strategies for improvement in data collection. MATERIALS AND METHODS: A PubMed search was conducted of publications in English, using MeSH terms sex, sex characteristics, gender identity, transgender, gender-nonconforming persons, clinical trials as topic, stroke. Of 249 search results, 217 were human or animal studies related to stroke, the majority of which were reviews, secondary analyses of stroke clinical trials, meta analyses, or retrospective studies, subject to the methods of sex and gender acquisition per the primary data source. Articles were reviewed, noting inclusion or absence of sex and gender definitions and trial design. Selected articles were supplemented with United States Food and Drug Administration, National Institutes of Health, and National Academy of Science, Engineering, and Medicine publications. RESULTS: The majority of preclinical studies continue to report sex as a binary variable, and the majority of stroke clinical trials report sex and gender as interchangeable and binary. Mindful trial design and statistical analysis can improve accuracy in the interpretation of sex and gender differences. Guidance exists to improve reporting on currently accepted sex and gender definitions, recommended data collection instruments, and appropriate statistical analyses. CONCLUSIONS: Despite acknowledgement of having failed to achieve diverse and proportionally balanced enrollment, sex and gender imbalance across the research continuum remains prevalent. Responsible incorporation of sex and gender in stroke clinical trials can be achieved through thoughtful study design, use of contemporary sex and gender definitions, inclusive prospective data collection, balanced enrollment with prespecified goals, and appropriate statistical analysis.

Academic culture beyond the individual: Group-level norms and college enrollment.

Although many scholars have written about culture in schools and discuss culture as a group-level phenomenon, quantitative studies tend to empirically examine culture at the individual-level. This study presents a group-level conceptualization of academic culture known as cultural heterogeneity-the presence of a diverse array of competing and conflicting cultural models-to examine whether variation in school-level academic orientation predicts college enrollment. We use the Educational Longitudinal Study of 2002 (ELS) to show that whereas academic press (or average school academic culture) is positively related to enrollment, variation in school academic culture is associated with declines in enrollment. These findings hold net of students' own academic behaviors and beliefs, background factors, and school characteristics. Thus, exposure to conflicting models of culture can lead youth to make decisions that do not reflect broader societal goals. This study addresses the misalignment between the conceptual and empirical definitions of culture in education by examining the link between school academic culture measured as a group-level process, which is consistent with how scholars discuss culture, and college enrollment.

Enhancing Enrollment in Acute Stroke Trials: Current State and Consensus Recommendations.

The Stroke Treatment Academic Industry Roundtable (STAIR) convened a session and workshop regarding enrollment in acute stroke trials during the STAIR XII meeting on March 22, 2023. This forum brought together stroke physicians and researchers, members of the National Institute of Neurological Disorders and Stroke, industry representatives, and members of the US Food and Drug Administration to discuss the current status and opportunities for improving enrollment in acute stroke trials. The workshop identified the most relevant issues impacting enrollment in acute stroke trials and addressed potential action items for each. Focus areas included emergency consent in the United States and other countries; careful consideration of eligibility criteria to maximize enrollment and representativeness; investigator, study coordinator, and pharmacist availability outside of business hours; trial enthusiasm/equipoise; site start-up including contractual issues; site champions; incorporation of study procedures into standard workflow as much as possible; centralized enrollment at remote sites by study teams using telemedicine; global trials; and coenrollment in trials when feasible. In conclusion, enrollment of participants is the lifeblood of acute stroke trials and is the rate-limiting step for testing an exciting array of new approaches to improve patient outcomes. In particular, efforts should be undertaken to broaden the medical community's understanding and implementation of emergency consent procedures and to adopt designs and processes that are easily incorporated into standard workflow and that improve trials' efficiencies and execution. Research and actions to improve enrollment in ongoing and future trials will improve stroke outcomes more broadly than any single therapy under consideration.

Allocation of authorship and patient enrollment among global clinical trials in oncology.

BACKGROUND: Oncology randomized controlled trials (RCTs) are increasingly global in scope. Whether authorship is equitably shared between investigators from high-income countries (HIC) and low-middle/upper-middle incomes countries (LMIC/UMIC) is not well described. The authors conducted this study to understand the allocation of authorship and patient enrollment across all oncology RCTs conducted globally. METHODS: A cross-sectional retrospective cohort study of phase 3 RCTs (published 2014-2017) that were led by investigators in HIC and recruited patients in LMIC/UMIC. FINDINGS: During 2014-2017, 694 oncology RCTs were published; 636 (92%) were led by investigators from HIC. Among these HIC-led trials, 186 (29%) enrolled patients in LMIC/UMIC. One-third (33%, 62 of 186) of RCTs had no authors from LMIC/UMIC. Forty percent (74 of 186) of RCTs reported patient enrollment by country; in 50% (37 of 74) of these trials, LMIC/UMIC contributed <15% of patients. The relationship between enrollment and authorship proportion is very strong and is comparable between LMIC/UMIC and HIC (Spearman's ρ LMIC/UMIC 0.824, p < .001; HIC 0.823, p < .001). Among the 74 trials that report country enrollment, 34% (25 of 74) have no authors from LMIC/UMIC. CONCLUSIONS: Among trials that enroll patients in HIC and LMIC/UMIC, authorship appears to be proportional to patient enrollment. This finding is limited by the fact that more than half of RCTs do not report enrollment by country. Moreover, there are important outliers as a significant proportion of RCTs had no authors from LMIC/UMIC despite enrolling patients in these countries. The findings in this study reflect a complex global RCT ecosystem that still underserves cancer control outside high-income settings.

Eligibility criteria in clinical trials in breast cancer: a cohort study.

BACKGROUND: Breast cancer (BC) is the most common cancer type in women. The purpose of this study was to assess the eligibility criteria in recent clinical trials in BC, especially those that can limit the enrollment of older patients as well as those with comorbidities and poor performance status. METHODS: Data on clinical trials in BC were extracted from ClinicalTrials.gov. Co-primary outcomes were proportions of trials with different types of the eligibility criteria. Associations between trial characteristics and the presence of certain types of these criteria (binary variable) were determined with univariate and multivariate logistic regression. RESULTS: Our analysis included 522 trials of systemic anticancer treatments started between 2020 and 2022. Upper age limits, strict exclusion criteria pertaining to comorbidities, and those referring to inadequate performance status of the patient were used in 204 (39%), 404 (77%), and 360 (69%) trials, respectively. Overall, 493 trials (94%) had at least one of these criteria. The odds of the presence of each type of the exclusion criteria were significantly associated with investigational site location and trial phase. We also showed that the odds of the upper age limits and the exclusion criteria involving the performance status were significantly higher in the cohort of recent trials compared with cohort of 309 trials started between 2010 and 2012 (39% vs 19% and 69% vs 46%, respectively; p < 0.001 for univariate and multivariate analysis in both comparisons). The proportion of trials with strict exclusion criteria was comparable between the two cohorts (p > 0.05). Only three of recent trials (1%) enrolled solely patients aged 65 or 70 and older. CONCLUSIONS: Many recent clinical trials in BC exclude large groups of patients, especially older adults, individuals with different comorbidities, and those with poor performance status. Careful modification of some of the eligibility criteria in these trials should be considered to allow investigators to assess the benefits and harms of investigational treatments in participants with characteristics typically encountered in clinical practice.