A point-of-care pilot randomized intervention to connect patients with cancer-induced financial toxicity to telehealth financial counseling.

PURPOSE: Elevated costs of cancer treatment can result in economic and psychological "financial toxicity" distress. This pilot study assessed the feasibility of a point-of-care intervention to connect adult patients with cancer-induced financial toxicity to telehealth-delivered financial counseling. METHODS: We conducted a three-armed parallel randomized pilot study, allocating newly referred patients with cancer and financial toxicity to individual, group accredited telehealth financial counseling, or usual care with educational material (1:1:1). We assessed the feasibility of recruitment, randomization, retention, baseline and post-intervention COmprehensive Score for Financial Toxicity (COST), and Telehealth Usability Questionnaire (TUQ) scores. RESULTS: Of 382 patients screened, 121 were eligible and enrolled. 58 (48%) completed the intervention (9 individual, 9 group counseling, 40 educational booklet). 29 completed follow-up surveys: 45% female, 17% African American, 79% white, 7% Hispanic, 55% 45-64 years old, 31% over 64, 34% lived in rural areas, 24% had cancer stage I, 21% II, 7% III, 31% IV. Baseline characteristics were balanced across arms, retention status, surveys completion. Mean (SD) COST was 12.4 (6.1) at baseline and 16.0 (8.4) post-intervention. Mean (SD) COST score differences were 6.3 (11.6) after individual counseling, 5.8 (8.5) after group counseling, and 2.5 (6.4) after usual care. Mean TUQ score among nine counseling participants was 5.5 (0.9) over 7.0. Non-parametric comparisons were not statistically meaningful. CONCLUSION: Recruitment and randomization were feasible, while study retention presented challenges. Nine participants reported good usability and satisfaction with telehealth counseling. Larger-scale trials focused on improving participation, retention, and impact of financial counseling among patients with cancer are justified.

Using Power Analysis to Choose the Unit of Randomization, Outcome, and Approach for Subgroup Analysis for a Multilevel Randomized Controlled Clinical Trial to Reduce Disparities in Cardiovascular Health.

We give examples of three features in the design of randomized controlled clinical trials which can increase power and thus decrease sample size and costs. We consider an example multilevel trial with several levels of clustering. For a fixed number of independent sampling units, we show that power can vary widely with the choice of the level of randomization. We demonstrate that power and interpretability can improve by testing a multivariate outcome rather than an unweighted composite outcome. Finally, we show that using a pooled analytic approach, which analyzes data for all subgroups in a single model, improves power for testing the intervention effect compared to a stratified analysis, which analyzes data for each subgroup in a separate model. The power results are computed for a proposed prevention research study. The trial plans to randomize adults to either telehealth (intervention) or in-person treatment (control) to reduce cardiovascular risk factors. The trial outcomes will be measures of the Essential Eight, a set of scores for cardiovascular health developed by the American Heart Association which can be combined into a single composite score. The proposed trial is a multilevel study, with outcomes measured on participants, participants treated by the same provider, providers nested within clinics, and clinics nested within hospitals. Investigators suspect that the intervention effect will be greater in rural participants, who live farther from clinics than urban participants. The results use published, exact analytic methods for power calculations with continuous outcomes. We provide example code for power analyses using validated software.

Telehealth Implementation Response to COVID-19 in the OneFlorida+ Clinical Research Network: Perspectives of Clinicians and Health Systems Leaders.

Introduction: The COVID-19 pandemic forced health systems worldwide to make rapid adjustments to patient care. Nationwide stay-at-home mandates and public health concerns increased demand for telehealth to maintain patients' continuity of care. These circumstances permitted observation of telehealth implementation in real-world settings at a large scale. This study aimed to understand clinician and health system leader (HSL) experiences in expanding, implementing, and sustaining telehealth during COVID-19 in the OneFlorida+ clinical research network. Methods: We conducted semistructured videoconference interviews with 5 primary care providers, 7 specialist providers, and 12 HSLs across 7 OneFlorida+ health systems and settings. Interviews were audiorecorded, transcribed, and summarized using deductive team-based template coding. We then used matrix analysis to organize the qualitative data and identify inductive themes. Results: Rapid telehealth implementation occurred even among sites with low readiness, facilitated by responsive planning, shifts in resource allocation, and training. Common hurdles in routine telehealth use, including technical and reimbursement issues, were also barriers to telehealth implementation. Acceptability of telehealth was influenced by benefits such as the providers' ability to view a patient's home environment and the availability of tools to enhance patient education. Lower acceptability stemmed from the inability to conduct physical examinations during the shutdown. Conclusions: This study identified a broad range of barriers, facilitators, and strategies for implementing telehealth within large clinical research networks. The findings can contribute to optimizing the effectiveness of telehealth implementation in similar settings, and point toward promising directions for telehealth provider training to improve acceptability and promote sustainability.

Avenues for Strengthening PCORnet's Capacity to Advance Patient-Centered Economic Outcomes in Patient-Centered Outcomes Research (PCOR).

PCORnet, the National Patient-Centered Clinical Research Network, provides the ability to conduct prospective and observational pragmatic research by leveraging standardized, curated electronic health records data together with patient and stakeholder engagement. PCORnet is funded by the Patient-Centered Outcomes Research Institute (PCORI) and is composed of 8 Clinical Research Networks that incorporate at total of 79 health system "sites." As the network developed, linkage to commercial health plans, federal insurance claims, disease registries, and other data resources demonstrated the value in extending the networks infrastructure to provide a more complete representation of patient's health and lived experiences. Initially, PCORnet studies avoided direct economic comparative effectiveness as a topic. However, PCORI's authorizing law was amended in 2019 to allow studies to incorporate patient-centered economic outcomes in primary research aims. With PCORI's expanded scope and PCORnet's phase 3 beginning in January 2022, there are opportunities to strengthen the network's ability to support economic patient-centered outcomes research. This commentary will discuss approaches that have been incorporated to date by the network and point to opportunities for the network to incorporate economic variables for analysis, informed by patient and stakeholder perspectives. Topics addressed include: (1) data linkage infrastructure; (2) commercial health plan partnerships; (3) Medicare and Medicaid linkage; (4) health system billing-based benchmarking; (5) area-level measures; (6) individual-level measures; (7) pharmacy benefits and retail pharmacy data; and (8) the importance of transparency and engagement while addressing the biases inherent in linking real-world data sources.

Stratified split sampling of electronic health records.

Although superficially similar to data from clinical research, data extracted from electronic health records may require fundamentally different approaches for model building and analysis. Because electronic health record data is designed for clinical, rather than scientific use, researchers must first provide clear definitions of outcome and predictor variables. Yet an iterative process of defining outcomes and predictors, assessing association, and then repeating the process may increase Type I error rates, and thus decrease the chance of replicability, defined by the National Academy of Sciences as the chance of "obtaining consistent results across studies aimed at answering the same scientific question, each of which has obtained its own data."[1] In addition, failure to account for subgroups may mask heterogeneous associations between predictor and outcome by subgroups, and decrease the generalizability of the findings. To increase chances of replicability and generalizability, we recommend using a stratified split sample approach for studies using electronic health records. A split sample approach divides the data randomly into an exploratory set for iterative variable definition, iterative analyses of association, and consideration of subgroups. The confirmatory set is used only to replicate results found in the first set. The addition of the word 'stratified' indicates that rare subgroups are oversampled randomly by including them in the exploratory sample at higher rates than appear in the population. The stratified sampling provides a sufficient sample size for assessing heterogeneity of association by testing for effect modification by group membership. An electronic health record study of the associations between socio-demographic factors and uptake of hepatic cancer screening, and potential heterogeneity of association in subgroups defined by gender, self-identified race and ethnicity, census-tract level poverty and insurance type illustrates the recommended approach.

Clinicians' perceptions of barriers to cervical cancer screening for women living with behavioral health conditions: a focus group study.

BACKGROUND: Women with behavioral health (BH) conditions (e.g., mental illness and substance abuse) receive fewer cervical cancer (CC) screenings, are diagnosed at more advanced cancer stages, and are less likely to receive specialized treatments. The aim of this study was to identify barriers that healthcare providers face in providing CC screening to women with BH conditions. METHODS: Guided by the Consolidated Framework for Implementation Research, we conducted four focus groups in North Florida with 26 primary care and BH clinicians and staff to examine perceived barriers to CC screening among their patients with BH conditions to guide the future development of a tailored cervical cancer screening and follow-up intervention. Thematic analysis was used to analyze verbatim transcripts from audiotaped focus groups. RESULTS: Three main themes of barriers emerged from the data: 1) BH conditions related barriers included a history of trauma, stigma and discrimination, and uncontrolled comorbid conditions, 2) System level barriers related to lack of integration between BH and primary care, and 3) Similar barriers to the general population including lack of health insurance, insufficient processes to send out reminders, and challenges with communicating with patients. CONCLUSIONS: Tailored CC screening interventions that address the unique needs of women with BH conditions are needed. Strategies that address improving trust between patients and healthcare providers, identifying avenues to improve receipt of screening during time-limited clinical visits, connecting BH and primary care providers, and addressing the social determinants of health have potential to improve CC screening rates for women with BH conditions.

Cost evaluation of tobacco control interventions in clinical settings: A systematic review.

Elucidating the cost implications of tobacco control interventions is a prerequisite to their adoption in clinical settings. This review fills a knowledge gap in characterizing the extent to which cost is measured in tobacco control studies. A search of English literature was conducted in the following electronic databases: MEDLINE, EconLit, PsychINFO, and CINAHL using MeSH terms from 2009 to 2018. Studies were reviewed by two independent reviewers and included if they were conducted in U.S. inpatient or outpatient facilities and reported costs associated with a tobacco control intervention. They were categorized according to evaluation type, clinical setting, target population, cost measures, and stakeholder perspective. Bias risk was evaluated for RCTs. Seventeen publications were included, representing counseling interventions (n = 8) and combination (i.e., counseling and pharmacotherapy) interventions (n = 9). Studies were categorized by evaluation type: cost-effectiveness analysis (n = 10), cost utility analysis (n = 3) and cost identification (n = 4). The selected studies targeted the following populations: general adults (n = 6), hospitalized/inpatient (n = 4), military/veterans (n = 4), individuals with low socioeconomic status (n = 4), mental health or medical comorbidities (n = 2), and pregnant women (n = 2). Intervention costs included personnel, medication, education material, technology, and overhead costs. Stakeholder perspectives included: healthcare organization (n = 10), payer (n = 8), patient (n = 2), and societal (n = 1). Few studies have reported the cost of tobacco control interventions in clinical settings. Cost is a critical outcome that should be consistently measured in evaluations of tobacco control interventions to promote their uptake in clinical settings.

A feasibility trial of parent HPV vaccine reminders and phone-based motivational interviewing.

BACKGROUND: We assessed the feasibility and acceptability of a sequential approach of parent-targeted HPV vaccine reminders and phone-based Motivation Interviewing (MI). METHODS: In 2016, we selected all 11- to 12-year-old boys and girls seen in one clinic whose vaccine records did not include the HPV vaccine (n=286). By gender, we individually randomized parents of adolescents to an interactive text message (74 girls and 45 boys), postcard reminder (46 boys and no girls because of previously demonstrated efficacy), or standard care group (75 girls and 46 boys). Reminders were sent with medical director permission and a HIPAA waiver. Two months after reminders, among the adolescents whose vaccine records still did not include the HPV vaccine, we selected a gender-stratified random sample of 20 parents for phone-based MI. We assessed the percentage of deliverable messages, the percentage of parents' responding to the interactive text message, parent acceptability of receiving a text message, and MI parent responsiveness and interviewer competence (MI Treatment Integrity Coding system). RESULTS: Nearly all messages were deliverable (98% of postcards and 74% of text messages). Six of the 88 parents (7%) receiving text messages scheduled an appointment through our interactive system. The acceptability survey response rate was 37% (38/102). Respondents were favorable toward vaccine reminders for all parents (82%). Among 20 sampled parents, 17 were reached by phone of whom 7 completed MI, 4 had or were getting the HPV vaccine for their child, and 5 expressed disinterest. Across the 7 MI calls, the interviewer was rated 100% MI adherent and scored an average 4.19 rating for Global Spirit. CONCLUSION: Without providing explicit consent to receive vaccine-related messages, parents nonetheless found postcards and interactive text messages acceptable. Centralizing MI to phone calls with trained staff was acceptable to parents and resulted in highly MI-adherent interviews.

Specific adverse childhood experiences and their association with other adverse childhood experiences, asthma and emotional, developmental and behavioral problems in childhood.

BACKGROUND: Adverse childhood experiences (ACEs) have lifelong health consequences, yet screening remains challenging. Particularly in clinical settings, brief screeners that could lead to comprehensive assessments may be more feasible. We explore how two ACEs (economic hardship, parental/caregiver divorce/separation) are associated with other ACEs, asthma, and emotional, developmental, or behavioral (EDB) problems. METHODS: Using the 2016 National Survey of Children's Health, we assessed the associations between ACEs and asthma and EDB problems and calculated sensitivities, specificities and predictive values. RESULTS: Parents frequently reported 1+ ACEs for their child (50.3%). Individual ACE frequency ranged from 4.2 to 29.6%; all were significantly associated with EDB problems (adjusted odds ratios (aORs): 2.2-5.1) and more ACEs confirmed higher odds. Two ACES (economic hardship, parental/caregiver divorce/separation) co-occurred frequently with other ACEs, having either predicted EDB problems similarly to other ACEs (aORs 1.8; 95% CI 1.4, 2.3) and having both greatly increased odds (aOR 3.8; 95% CI 2.8, 5.2). The negative predictive value of EDB problems associated with citing neither ACE was high (95.7%). Similar trends with asthma were observed. CONCLUSIONS: Economic hardship and caregiver separation are strongly associated with other ACEs, EDB problems and asthma. A brief screener including these ACEs may reduce clinical barriers to broader ACEs screening.

Tobacco-Related Counseling and Documentation in Adolescent Primary Care Practice: Challenges and Opportunities.

INTRODUCTION: Primary care visits present an opportunity to reduce tobacco use and tobacco smoke exposure (TSE) among adolescents. To date, few studies have examined tobacco-related electronic health record (EHR) documentation in adolescent visits. The purpose of this study was to (1) describe tobacco-related EHR documentation practices in adolescent care clinics, including whether alternative tobacco products, parental use, and TSE were addressed; and (2) identify aspects of adolescent tobacco use that may inform EHR updates and counseling and documentation practices. METHODS: Following a convergent mixed-methods design, we conducted an EHR review of 508 adolescent well-child visits, performed focus groups with pediatric providers and staff, and conducted in-depth interviews with adolescent patients. Record review data and interview transcripts were analyzed and interpreted concurrently. RESULTS: In the EHR review, cigarette screening was documented in 92.3% of visits, smokeless tobacco screening in 51.4%, parental tobacco use in 23.2%, and home TSE in 33.1% of visits. Smoking status options were not mutually exclusive and did not include noncigarette products. No records documented assessment of e-cigarette use, despite nearly half of adolescent interview respondents citing these as the most popular products among adolescents. In interviews, adolescents discussed their experiences with alternative tobacco/nicotine products more than cigarettes. CONCLUSIONS: Tobacco use status prompts should be revised for clarity and include noncigarette tobacco products and TSE. Provider education on noncigarette products and TSE assessment is needed. Improvements in EHR systems, resources, and tools can lead to better tobacco screening, prevention, and treatment practices among primary care providers. IMPLICATIONS: Clinical guidelines call for pediatricians to assess and treat adolescent and parental tobacco use during primary care visits. The use of electronic health records (EHRs) can improve screening and counseling practices; however, few studies have examined tobacco-related EHR documentation practices in adolescent care settings. This mixed-methods study found low rates of EHR documentation related to noncigarette nicotine/tobacco products, parental tobacco use, and tobacco smoke exposure. These results demonstrate the need for increased provider training and EHR modifications to facilitate comprehensive tobacco control efforts in the adolescent population.

Rural-urban and racial-ethnic differences in awareness of direct-to-consumer genetic testing.

BACKGROUND: Access to direct-to-consumer genetic testing services has increased in recent years. However, disparities in knowledge and awareness of these services are not well documented. We examined awareness of genetic testing services by rural/urban and racial/ethnic status. METHODS: Analyses were conducted using pooled cross-sectional data from 4 waves (2011-2014) of the Health Information National Trends Survey (HINTS). Descriptive statistics compared sample characteristics and information sources by rural/urban residence. Logistic regression was used to examine the relationship between geography, racial/ethnic status, and awareness of genetic testing, controlling for sociodemographic characteristics. RESULTS: Of 13,749 respondents, 16.7% resided in rural areas, 13.8% were Hispanic, and 10.1% were non-Hispanic black. Rural residents were less likely than urban residents to report awareness of genetic testing (OR = 0.74, 95% CI = 0.63-0.87). Compared with non-Hispanic whites, racial/ethnic minorities were less likely to be aware of genetic testing: Hispanic (OR = 0.68, 95% CI = 0.56-0.82); and non-Hispanic black (OR = 0.74, 95% CI = 0.61-0.90). CONCLUSIONS: Rural-urban and racial-ethnic differences exist in awareness of direct-to-consumer genetic testing. These differences may translate into disparities in the uptake of genetic testing, health behavior change, and disease prevention through precision and personalized medicine.

"The problem is people don't know how to talk to you:" How Medicaid recipients understand and use health plan report cards and instruction sheets.

This study sought to understand low income, ethnically diverse individuals' needs, comprehension, and opinions of comparative quality information as presented in state Medicaid health plan report cards (HPRCs). Twenty-two focus groups were conducted with urban and rural Medicaid recipients in three ethnic groups. Results showed the wording of some domains was misunderstood and an overabundance of domains that are irrelevant to the individual attenuated attention. Combinations of visual and verbal information and well-organized designs aided attention and comprehension. Stating where the data came from was important. Some key differences between ethnicity and geographic areas were noted.

Defining 'quality' from the patient's perspective: findings from focus groups with Medicaid beneficiaries and implications for public reporting.

BACKGROUND: With an increased emphasis on patient-centred outcomes and research, investigators seek to understand aspects of health care that are most important to patients. Such information is essential for developing report cards that present health-care quality information for consumers, which many states are adopting as a strategy to promote consumer choice. OBJECTIVE: This study examined the processes that women in Medicaid follow for selecting health plans and explored their definitions of 'good' and 'poor' quality health care. DESIGN: We conducted focus groups with Medicaid beneficiaries in four Texas communities, using quota sampling to ensure representation of different racial/ethnic, eligibility and geographic groups. RESULTS: We conducted 22 focus groups with 102 participants between October 2012 and January 2013. In a free-list exercise, 'doctors' represented the most important aspect of health care to participants, followed by cost, attention, coverage and respect. Discussions of health-care quality revealed an even mix of structural factors (e.g. timeliness) and interpersonal factors (e.g. communication), although few differences were observed by beneficiary characteristics. Participants linked themes in their overall framing of 'quality' - revealing processes of care that affect health outcomes (e.g. discontinuity of care resulting from poor communication with providers) and which were often mediated by advocate providers who assisted patients experiencing barriers to services. DISCUSSION AND CONCLUSIONS: Findings support other studies that highlight the importance of the patient-provider relationship. Patient-centred definitions of health-care quality can complement predominant provider-centred conceptual frameworks and better inform initiatives for public reporting of quality measures in these populations.

Improving Adolescent Health Risk Assessment: A Multi-method Pilot Study.

Objectives Given poor compliance by providers with adolescent health risk assessment (HRA) in primary care, we describe the development and feasibility of using a health information technology (HIT)-enhanced HRA to improve the frequency of HRAs in diverse clinical settings, asking adolescents' recall of quality of care as a primary outcome. Methods We conducted focus groups and surveys with key stakeholders (Phase I) , including adolescents, clinic staff and providers to design and implement an intervention in a practice-based research network delivering private, comprehensive HRAs via tablet (Phase II). Providers and adolescents received geo-coded community resources according to individualized risks. Following the point-of-care implementation , we collected patient-reported outcomes using post-visit quality surveys (Phase III). Patient-reported outcomes from intervention and comparison clinics were analyzed using a mixed-model, fitted separately for each survey domain. Results Stakeholders agreed upon an HIT-enhanced HRA (Phase I). Twenty-two academic and community practices in north-central Florida then recruited 609 diverse adolescents (14-18 years) during primary care visits over 6 months; (mean patients enrolled = 28; median = 20; range 1-116; Phase II). Adolescents receiving the intervention later reported higher receipt of confidential/private care and counseling related to emotions and relationships (adjusted scores 0.42 vs 0.08 out of 1.0, p < .01; 0.85 vs 0.57, p < .001, respectively, Phase III) than those receiving usual care. Both are important quality indicators for adolescent well-child visits. Conclusions Stakeholder input was critical to the acceptability of the HIT-enhanced HRA. Patient recruitment data indicate that the intervention was feasible in a variety of clinical settings and the pilot evaluation data indicate that the intervention may improve adolescents' perceptions of high quality care.

Quality of Care for Chronic Conditions Among Disabled Medicaid Enrollees: An Evaluation of a 1915 (b) and (c) Waiver Program.

IMPORTANCE: Examining the impact of Medicaid-managed care home-based and community-based service (HCBS) alternatives to institutional care is critical given the recent rapid expansion of these models nationally. OBJECTIVE: We analyzed the effects of STAR+PLUS, a Texas Medicaid-managed care HCBS waiver program for adults with disabilities on the quality of chronic disease care. DESIGN, SETTING, AND PARTICIPANTS: We compared quality before and after a mandatory transition of disabled Medicaid enrollees older than 21 years from fee-for-service (FFS) or primary care case management (PCCM) to STAR+PLUS in 28 counties, relative to enrollees in counties remaining in the FFS or PCCM models. MEASURES AND ANALYSIS: Person-level claims and encounter data for 2006-2010 were used to compute adherence to 6 quality measures. With county as the independent sampling unit, we employed a longitudinal linear mixed-model analysis accounting for administrative clustering and geographic and individual factors. RESULTS: Although quality was similar among programs at baseline, STAR+PLUS enrollees experienced large and sustained improvements in use of ß-blockers after discharge for heart attack (49% vs. 81% adherence posttransition; P<0.01) and appropriate use of systemic corticosteroids and bronchodilators after a chronic obstructive pulmonary disease event (39% vs. 68% adherence posttransition; P<0.0001) compared with FFS/PCCM enrollees. No statistically significant effects were identified for quality measures for asthma, diabetes, or cardiovascular disease. CONCLUSION: In 1 large Medicaid-managed care HCBS program, the quality of chronic disease care linked to acute events improved while that provided during routine encounters appeared unaffected.

Human papillomavirus vaccine administration among Medicaid providers who consistently recommended vaccination.

We examined factors potentially related to providers' self-reported human papillomavirus vaccine administration to female Medicaid enrollees among providers who consistently recommended vaccination. Some pronounced variability was observed in characteristics among providers who consistently administered vaccination, including provider age, race, and Vaccines for Children enrollment; patient/parent vaccine refusal; patient race/ethnicity; and patient volume.

The Burden of Cancer and Pre-cancerous Conditions Among Transgender Individuals in a Large Healthcare Network.

The current study aimed to examine the prevalence of and risk factors for cancer and pre-cancerous conditions, comparing transgender and cisgender individuals, using 2012-2023 electronic health record data from a large healthcare system. We identified 2,745 transgender individuals using a previously validated computable phenotype and 54,900 matched cisgender individuals. We calculated the prevalence of cancer and pre-cancer related to human papillomavirus (HPV), human immunodeficiency virus (HIV), tobacco, alcohol, lung, breast, colorectum, and built multivariable logistic models to examine the association between gender identity and the presence of cancer or pre-cancer. Results indicated similar odds of developing cancer across gender identities, but transgender individuals exhibited significantly higher risks for pre-cancerous conditions, including alcohol-related, breast, and colorectal pre-cancers compared to cisgender women, and HPV-related, tobacco-related, alcohol-related, and colorectal pre-cancers compared to cisgender men. These findings underscore the need for tailored interventions and policies addressing cancer health disparities affecting the transgender population.

Machine Learning Prediction of Autism Spectrum Disorder Through Linking Mothers' and Children's Electronic Health Record Data.

Autism spectrum disorder (ASD) is a neurodevelopmental disorder typically diagnosed in children. Early detection of ASD, particularly in girls who are often diagnosed late, can aid long-term development for children. We aimed to develop machine learning models for predicting ASD diagnosis in children, both boys and girls, using child-mother linked electronic health records (EHRs) data from a large clinical research network. Model features were children and mothers' risk factors in EHRs, including maternal health factors. We tested XGBoost and logistic regression with Random Oversampling (ROS) and Random Undersampling (RUS) to address imbalanced data. Logistic regression with RUS considering a three-year observation window for children's risk factors achieved the best performance for predicting ASD among the overall study population (AUROC = 0.798), boys (AUROC = 0.786), and girls (AUROC = 0.791). We calculated SHAP values to quantify the impacts of important clinical and sociodemographic risk factors.

Development and validation of a race-agnostic computable phenotype for kidney health in adult hospitalized patients.

Standard race adjustments for estimating glomerular filtration rate (GFR) and reference creatinine can yield a lower acute kidney injury (AKI) and chronic kidney disease (CKD) prevalence among African American patients than non-race adjusted estimates. We developed two race-agnostic computable phenotypes that assess kidney health among 139,152 subjects admitted to the University of Florida Health between 1/2012-8/2019 by removing the race modifier from the estimated GFR and estimated creatinine formula used by the race-adjusted algorithm (race-agnostic algorithm 1) and by utilizing 2021 CKD-EPI refit without race formula (race-agnostic algorithm 2) for calculations of the estimated GFR and estimated creatinine. We compared results using these algorithms to the race-adjusted algorithm in African American patients. Using clinical adjudication, we validated race-agnostic computable phenotypes developed for preadmission CKD and AKI presence on 300 cases. Race adjustment reclassified 2,113 (8%) to no CKD and 7,901 (29%) to a less severe CKD stage compared to race-agnostic algorithm 1 and reclassified 1,208 (5%) to no CKD and 4,606 (18%) to a less severe CKD stage compared to race-agnostic algorithm 2. Of 12,451 AKI encounters based on race-agnostic algorithm 1, race adjustment reclassified 591 to No AKI and 305 to a less severe AKI stage. Of 12,251 AKI encounters based on race-agnostic algorithm 2, race adjustment reclassified 382 to No AKI and 196 (1.6%) to a less severe AKI stage. The phenotyping algorithm based on refit without race formula performed well in identifying patients with CKD and AKI with a sensitivity of 100% (95% confidence interval [CI] 97%-100%) and 99% (95% CI 97%-100%) and a specificity of 88% (95% CI 82%-93%) and 98% (95% CI 93%-100%), respectively. Race-agnostic algorithms identified substantial proportions of additional patients with CKD and AKI compared to race-adjusted algorithm in African American patients. The phenotyping algorithm is promising in identifying patients with kidney disease and improving clinical decision-making.

Geographic variation and racial disparities in adoption of newer glucose-lowering drugs with cardiovascular benefits among US Medicare beneficiaries with type 2 diabetes.

BACKGROUND: Prior studies have shown disparities in the uptake of cardioprotective newer glucose-lowering drugs (GLDs), including sodium-glucose cotranwsporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP1a). This study aimed to characterize geographic variation in the initiation of newer GLDs and the geographic variation in the disparities in initiating these medications. METHODS: Using 2017-2018 claims data from a 15% random nationwide sample of Medicare Part D beneficiaries, we identified individuals diagnosed with type 2 diabetes (T2D), who had ≥1 GLD prescriptions, and did not use SGLT2i or GLP1a in the year prior to the index date,1/1/2018. Patients were followed up for a year. The cohort was spatiotemporally linked to Dartmouth hospital-referral regions (HRRs), with each patient assigned to 1 of 306 HRRs. We performed multivariable Poisson regression to estimate adjusted initiation rates, and multivariable logistic regression to assess racial disparities in each HRR. RESULTS: Among 795,469 individuals with T2D included in the analyses, the mean (SD) age was 73 (10) y, 53.3% were women, 12.2% were non-Hispanic Black, and 7.2% initiated a newer GLD in the follow-up year. In the adjusted model including clinical factors, compared to non-Hispanic White patients, non-Hispanic Black (initiation rate ratio, IRR [95% CI]: 0.66 [0.64-0.68]), American Indian/Alaska Native (0.74 [0.66-0.82]), Hispanic (0.85 [0.82-0.87]), and Asian/Pacific islander (0.94 [0.89-0.98]) patients were less likely to initiate newer GLDs. Significant geographic variation was observed across HRRs, with an initiation rate spanning 2.7%-13.6%. CONCLUSIONS: This study uncovered substantial geographic variation and the racial disparities in initiating newer GLDs.