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Prospective clinical research studies are essential for determining the effectiveness and safety of drugs, medical devices, and healthcare delivery interventions. However, low enrollment, particularly among Black and Hispanic patients, challenges the generalizability of results and fairness of research. Leveraging insights from behavioral economics to modify the content of messages recruiting patients to join research studies may increase enrollment and representativeness of trial populations. Method of outreach, source of outreach, message framing, and financial incentives will have important effects on enrollment fraction of Black and Hispanic patients electronically approached for participation in a prospective clinical research study. ITERATE (NCT05827718) is a series of 4 randomized clinical trials (RCTs) designed to rigorously, systematically, and iteratively test the effects of different messaging strategies informed by behavioral economic theory on the enrollment of Black and Hispanic individuals into the Penn Medicine BioBank (PMBB), a prospective registry. For all 4 RCTs, we will identify patients eligible for enrollment in the PMBB (those with ≥ 1 encounter with the University of Pennsylvania Health System in the past 3 months, a phone number able to receive text messages or a valid email address on file, no history of consenting to or declining enrollment in the PMBB, and able to provide their own consent) and randomly assign them to receive different outreach messages. RCT 1 will test the method of outreach (email vs. text message vs. email + text message); RCT 2, source of outreach (research team vs. clinical team); RCT 3, message framing (appeal to altruism vs. appeal to social proof vs. control); and RCT 4, financial incentive (none vs. medium guarantee vs. small guarantee + small lottery vs. medium lottery vs. large lottery). In each RCT, at least 50% of the participants will be Black or Hispanic. The primary outcome of each RCT is enrollment fraction, defined as the number of participants who enroll in the PMBB divided by the total number of participants who received an outreach message, compared between arms among both Black and Hispanic patients. Secondary outcomes will include overall enrollment fraction and enrollment fraction among White patients. The “winning” strategies in earlier RCTs will be incorporated as the “standard of care” in the subsequent RCTs.

Ecological momentary assessment (EMA) is increasingly used to evaluate behavioral health processes over extended time periods. The validity of EMA for providing representative, real-world data with high temporal precision is threatened to the extent that EMA compliance drops over time. This research builds on prior short-term studies by evaluating the time course of EMA compliance over 9 weeks and examines predictors of weekly compliance rates among cigarette-using adults. A total of 257 daily cigarette-using adults participating in a randomized controlled trial for smoking cessation completed daily smartphone EMA assessments, including 1 scheduled morning assessment and 4 random assessments per day. Weekly EMA compliance was calculated and multilevel modeling assessed the rate of change in compliance over the 9-week assessment period. Participant and study characteristics were examined as predictors of overall compliance and changes in compliance rates over time. Compliance was higher for scheduled morning assessments (86%) than for random assessments (58%) at the beginning of the EMA period (P<.001). EMA compliance declined linearly across weeks, and the rate of decline was greater for morning assessments (2% per week) than for random assessments (1% per week; P<.001). Declines in compliance were stronger for younger participants (P<.001), participants who were employed full-time (P=.03), and participants who subsequently dropped out of the study (P<.001). Overall compliance was higher among White participants compared to Black or African American participants (P=.001). This study suggests that EMA compliance declines linearly but modestly across lengthy EMA protocols. In general, these data support the validity of EMA for tracking health behavior and hypothesized treatment mechanisms over the course of several months. Future work should target improving compliance among subgroups of participants and investigate the extent to which rapid declines in EMA compliance might prove useful for triggering interventions to prevent study dropout. ClinicalTrials.gov NCT03262662; https://clinicaltrials.gov/ct2/show/NCT03262662.

While subgroup analyses are common in epidemiologic research, restriction to subgroup members can yield imprecise estimates. We aimed to demonstrate how methods extending inferences to external targets improve precision of subgroup estimates under the major assumption effects differ between subgroup members and nonmembers due to measured effect measure modifiers (EMMs) and membership is independent of the effect after conditioning on EMMs. We applied this approach in the Panitumumab Randomized Trial in Combination with Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy. Assuming Hispanic vs non-Hispanic ethnicity was independent of the effect conditional on measured EMMs, we weighted non-Hispanic White participants to resemble Hispanic participants in EMMs, assigned Hispanic participants weights of 1, and estimated weighted 9-month progression-free survival differences (PFSDs) with 95% confidence limits from 2000 bootstraps. We also explored outcome-based approaches. Finally, we examined a situation where the method generates biased estimates (targeting participants with mutant-type Kirsten rat sarcoma virus (KRAS), which determines efficacy). While the Hispanic participant-only analysis estimated a 9-month panitumumab PFSD of −7.1% (95% CI −32%, 19%), the weighted combined estimate targeting Hispanic participants was much more precise (−3.7%, 95% CI: −16%, 9.2%). Other analytic approaches yielded similar results. Meanwhile, the weighted combined estimate targeting mutant-type KRAS participants appeared biased (−2.2%, 95% CI: −7.5%, 3.3%) vs the subgroup-only estimate (−11%, 95% CI: −18%, −2.3%). While extending inferences from study populations to specific targets can improve the precision of estimates in small subgroups, violating key assumptions creates bias for many subgroups of interest. Understanding the benefits and harms in specific subgroups of patients is an important part of epidemiologic and public health research. Unfortunately, commonly used methods to do subgroup analyses can result in estimates with lots of uncertainty. Repurposing methods that have traditionally been used to “generalize” or “transport” effect estimates from specific studies to the types of patients more likely to be encountered in the real world could be used to obtain more informative estimates in subgroups without ignoring differences between different types of patients. In this project, we applied this strategy to the Panitumumab Randomized Trial in Combination with Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy (PRIME) to create much less variable estimates of the treatment effect in Hispanic participants without ignoring the fact that there were more Hispanic participants with a tumor variation that changed the effect of treatment. On the other hand, when we tried to apply this strategy to improve estimates in patients with that tumor variation, we ended up with a misleading effect estimate. While these methods can reduce uncertainty about the benefits of treatment in specific subgroups interesting to researchers, they can result in incorrect subgroup estimates when their assumptions are violated. [Display omitted] •Methods extending inferences to targets can lower subgroup analyses’ variance.•These methods should only be used when key assumptions about heterogeneity are met.•We demonstrate benefits and risks of the approach using simulated and real data.•Research estimating effects in some small subgroups may benefit from these methods.•Estimates resulting from these methods should be interpreted with caution.

Social workers assess and intervene to prevent harm among clients at risk of harm to self (HTS) and harm to others (HTO) with a firearm. This study sought to assess the impact of client race on social workers’ approaches to reduce firearm access when they weighed voluntary (e.g., store out-of-home) and involuntary (e.g., extreme risk protection order) removal methods. We considered the role of social workers’ self-identified race as a moderator of this relationship, comparing white (single race) and Black, Indigenous, and People of Color (BIPOC) social workers. A survey was distributed to Washington state social workers ( n = 9073) who were presented with two case vignettes, each randomized to view the client’s race as Black or white. Logistic regression was used to assess the association between the client’s race and the pursuit of voluntary or involuntary methods, stratified by social workers’ race. Among the participants ( n = 1306), 26% pursued at least one involuntary care plan option for the HTS client, and 59% for the HTO client. The Black client at risk of HTS had lower odds of an involuntary care plan option compared to the white client (OR = 0.69, 95% CI 0.54–0.88), while the Black client at risk of HTO had higher odds of an involuntary care plan options (OR = 1.13, 95% CI 1.07–1.66). These associations were not statistically significantly different between white (single race selected) and BIPOC social workers. This study contributes to the growing understanding of potential racial disparities in social workers’ decision-making regarding firearm access reduction strategies.

Objective To assess implicit bias by administrating the Modified Finnegan Score (MFS) for quantifying neonatal opioid withdrawal and to evaluate risk of decreased opioid treatment of Black versus White infants. Study Design Study participants were nurses recruited from a large tertiary care center who received three clinical vignettes portraying withdrawing infants and were randomized to receive an accompanying photo of either a Black or White infant. MFS results were compared for identical vignettes based on race of infant photo. Results Out of 275 nurses, 70 completed the survey. In vignette 2, nurses aged ≤35 years scored Black infants lower than White infants (MFS=8.3 ± 2 vs. 9.5 ± 1.2, p =0.012). Nurses with <5 years of experience and ≤10 years of experience also scored Black infants lower for the same vignette (8.2 ± 2.3 vs. 9.6 ± 1.2, p =0.032 and 8.3 ± 2 vs. 9.5 ± 1.2, p =0.0083). Conclusion Implicit bias may contribute to the difference in opioid treatment.

The development of COVID-19 vaccines was an important breakthrough for ending the pandemic. However, people refusing to get vaccinated diminish the level of community protection afforded to others. In the United States, White evangelicals have proven to be a particularly difficult group to convince to get vaccinated. Here we investigate whether this group can be persuaded to get vaccinated. To do this, we leverage data from two survey experiments, one fielded prior to approval of COVID-19 vaccines (study 1) and one fielded after approval (study 2). In both experiments, respondents were randomly assigned to treatment messages to promote COVID-19 vaccination. In study 1, we find that a message that emphasizes community interest and reciprocity with an invocation of embarrassment for choosing not to vaccinate is the most effective at increasing uptake intentions, while values-consistent messaging appears to be ineffective. In contrast, in study 2 we observe that this message is no longer effective and that most messages produce little change in vaccine intent. This inconsistency may be explained by the characteristics of White evangelicals who remain unvaccinated vis a vis those who got vaccinated. These results demonstrate the importance of retesting messages over time, the apparent limitations of values-targeted messaging, and document the need to consider heterogeneity even within well-defined populations. This work also cautions against drawing broad conclusions from studies carried out at a single point in time during the COVID-19 pandemic.

In this large study, the mortality benefits of reducing levels of fine particulate matter air pollution were greater for low-income and higher-income Black persons and for low-income White persons than for higher-income White persons.

Adjustment for race is discouraged in lung-function testing, but the implications of adopting race-neutral equations have not been comprehensively quantified. We obtained longitudinal data from 369,077 participants in the National Health and Nutrition Examination Survey, U.K. Biobank, the Multi-Ethnic Study of Atherosclerosis, and the Organ Procurement and Transplantation Network. Using these data, we compared the race-based 2012 Global Lung Function Initiative (GLI-2012) equations with race-neutral equations introduced in 2022 (GLI-Global). Evaluated outcomes included national projections of clinical, occupational, and financial reclassifications; individual lung-allocation scores for transplantation priority; and concordance statistics (C statistics) for clinical prediction tasks. Among the 249 million persons in the United States between 6 and 79 years of age who are able to produce high-quality spirometric results, the use of GLI-Global equations may reclassify ventilatory impairment for 12.5 million persons, medical impairment ratings for 8.16 million, occupational eligibility for 2.28 million, grading of chronic obstructive pulmonary disease for 2.05 million, and military disability compensation for 413,000. These potential changes differed according to race; for example, classifications of nonobstructive ventilatory impairment may change dramatically, increasing 141% (95% confidence interval [CI], 113 to 169) among Black persons and decreasing 69% (95% CI, 63 to 74) among White persons. Annual disability payments may increase by more than $1 billion among Black veterans and decrease by $0.5 billion among White veterans. GLI-2012 and GLI-Global equations had similar discriminative accuracy with regard to respiratory symptoms, health care utilization, new-onset disease, death from any cause, death related to respiratory disease, and death among persons on a transplant waiting list, with differences in C statistics ranging from -0.008 to 0.011. The use of race-based and race-neutral equations generated similarly accurate predictions of respiratory outcomes but assigned different disease classifications, occupational eligibility, and disability compensation for millions of persons, with effects diverging according to race. (Funded by the National Heart Lung and Blood Institute and the National Institute of Environmental Health Sciences.).

OBJECTIVE: The Informatics for Diabetes Education and Telemedicine (IDEATel) project randomized ethnically diverse underserved older adults with diabetes to a telemedicine intervention or usual care. Intervention participants had lower A1C levels over 5 years. New analyses were performed to help better understand this difference. RESEARCH DESIGN AND METHODS: IDEATel randomized Medicare beneficiaries with diabetes (n = 1,665) to receive home video visits with a diabetes educator and upload glucose levels every 4-6 weeks or usual care (2000-2007). Annual measurements included BMI, A1C (primary outcome), and completion of questionnaires. Mixed-model analyses were performed using random effects to adjust for clustering within primary care physicians. RESULTS: At baseline, A1C levels (mean ± SD) were 7.02 ± 1.25% in non-Hispanic whites (n = 821), 7.58 ± 1.78% in non-Hispanic blacks (n = 248), and 7.79 ± 1.68% in Hispanics (n = 585). Over time, lower A1C levels were associated with more glucose uploads (P = 0.02) and female sex (P = 0.002). Blacks, Hispanics, and insulin-users had higher A1C levels than non-Hispanic whites (P < 0.0001). BMI was not associated with A1C levels. Blacks and Hispanics had significantly fewer uploads than non-Hispanic whites over time. Hispanics had the highest baseline A1C levels and showed the greatest improvement in the intervention, but, unlike non-Hispanic whites, Hispanics did not achieve A1C levels <7.0% at 5 years. CONCLUSIONS: Racial/ethnic disparities were observed in this cohort of underserved older adults with diabetes. The IDEATel telemedicine intervention was associated with improvement in glycemic control, particularly in Hispanics, who had the highest baseline A1C levels, suggesting that telemedicine has the potential to help reduce disparities in diabetes management.

Therapeutic inertia may contribute to racial and ethnic differences in blood pressure (BP) control. To determine the association between race and ethnicity and therapeutic inertia in the Systolic Blood Pressure Intervention Trial (SPRINT). This cross-sectional study was a secondary analysis of data from SPRINT, a randomized clinical trial comparing intensive (<120 mm Hg) vs standard (<140 mm Hg) systolic BP treatment goals. Participants were enrolled between November 8, 2010, and March 15, 2013, with a median follow-up 3.26 years. Participants included adults aged 50 years or older at high risk for cardiovascular disease but without diabetes, previous stroke, or heart failure. The present analysis was restricted to participant visits with measured BP above the target goal. Analyses for the present study were performed in from October 2020 through March 2021. Self-reported race and ethnicity, mutually exclusively categorized into groups of Hispanic, non-Hispanic Black, or non-Hispanic White participants. Therapeutic inertia, defined as no antihypertensive medication intensification at each study visit where the BP was above target goal. The association between self-reported race and ethnicity and therapeutic inertia was estimated using generalized estimating equations and stratified by treatment group. Antihypertensive medication use was assessed with pill bottle inventories at each visit. Blood pressure was measured using an automated device. A total of 8556 participants, including 4141 in the standard group (22 844 participant-visits; median age, 67.0 years [IQR, 61.0-76.0 years]; 1467 women [35.4%]) and 4415 in the intensive group (35 453 participant-visits; median age, 67.0 years [IQR, 61.0-76.0 years]; 1584 women [35.9%]) with at least 1 eligible study visit were included in the present analysis. Among non-Hispanic White, non-Hispanic Black, and Hispanic participants, the overall prevalence of therapeutic inertia in the standard vs intensive groups was 59.8% (95% CI, 58.9%-60.7%) vs 56.0% (95% CI, 55.2%-56.7%), 56.8% (95% CI, 54.4%-59.2%) vs 54.5% (95% CI, 52.4%-56.6%), and 59.7% (95% CI, 56.5%-63.0%) vs 51.0% (95% CI, 47.4%-54.5%), respectively. The adjusted odds ratios in the standard and intensive groups for therapeutic inertia associated with non-Hispanic Black vs non-Hispanic White participants were 0.85 (95% CI, 0.79-0.92) and 0.94 (95% CI, 0.88-1.01), respectively. The adjusted odds ratios for therapeutic inertia comparing Hispanic vs non-Hispanic White participants were 1.00 (95% CI, 0.90-1.13) and 0.89 (95% CI, 0.79-1.00) in the standard and intensive groups, respectively. Among SPRINT participants above BP target goal, this cross-sectional study found that therapeutic inertia prevalence was similar or lower for non-Hispanic Black and Hispanic participants compared with non-Hispanic White participants. These findings suggest that a standardized approach to BP management, as used in SPRINT, may help ensure equitable care and could reduce the contribution of therapeutic inertia to disparities in hypertension. ClinicalTrials.gov identifier: NCT01206062.