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As the HIV-infected population ages and the burden of chronic comorbidities increases, adherence to medications for HIV and diabetes and hypertension is crucial to improve outcomes. We pilot-tested a pictorial aid intervention to improve medication adherence for both HIV and common chronic conditions. Adult patients with HIV and diabetes (DM) and/or hypertension (HTN) attending a clinic for underserved patients and at risk for poor health outcomes were enrolled. Patients were randomized to receive either a pictorial aid intervention (a photographic representation of their medications, the indications, and the dosing schedule) or a standard clinic visit discharge medication list. Adherence to antiretroviral therapy (ART) for HIV and therapy for DM or HTN was compared. Predictors of ART adherence at baseline were determined using logistic regression. Medication adherence was assessed using medication possession ratio (MPR) for the 6-month interval before and after the intervention. Change in adherence by treatment group was compared by ANOVA. Among the 46 participants, there was a trend towards higher adherence to medications for HIV compared with medications for hypertension/diabetes (baseline median MPR for ART 0.92; baseline median MPR for the medication for the comorbid condition 0.79,p = 0.07). The intervention was feasible to implement and satisfaction with the intervention was high. With a small sample size, the intervention did not demonstrate significant improvement in adherence to medications for HIV or comorbid conditions. Patients with HIV are often medically complex and may have multiple barriers to medication adherence. Medication adherence is a multifaceted process and adherence promotion interventions require an approach that targets patient-specific barriers. [ABSTRACT FROM PUBLISHER]

Background: Clinically important medication errors are common after hospital discharge. They include preventable or ameliorable adverse drug events (ADEs), as well as medication discrepancies or nonadherence with high potential for future harm (potential ADEs).Objective: To determine the effect of a tailored intervention on the occurrence of clinically important medication errors after hospital discharge.Design: Randomized, controlled trial with concealed allocation and blinded outcome assessors. (ClinicalTrials.gov registration number: NCT00632021)Setting: Two tertiary care academic hospitals.Patients: Adults hospitalized with acute coronary syndromes or acute decompensated heart failure.Intervention: Pharmacist-assisted medication reconciliation, inpatient pharmacist counseling, low-literacy adherence aids, and individualized telephone follow-up after discharge.Measurements: The primary outcome was the number of clinically important medication errors per patient during the first 30 days after hospital discharge. Secondary outcomes included preventable or ameliorable ADEs, as well as potential ADEs.Results: Among 851 participants, 432 (50.8%) had 1 or more clinically important medication errors; 22.9% of such errors were judged to be serious and 1.8% life-threatening. Adverse drug events occurred in 258 patients (30.3%) and potential ADEs in 253 patients (29.7%). The intervention did not significantly alter the per-patient number of clinically important medication errors (unadjusted incidence rate ratio, 0.92 [95% CI, 0.77 to 1.10]) or ADEs (unadjusted incidence rate ratio, 1.09 [CI, 0.86 to 1.39]). Patients in the intervention group tended to have fewer potential ADEs (unadjusted incidence rate ratio, 0.80 [CI, 0.61 to 1.04]).Limitation: The characteristics of the study hospitals and participants may limit generalizability.Conclusion: Clinically important medication errors were present among one half of patients after hospital discharge and were not significantly reduced by a health-literacy-sensitive, pharmacist-delivered intervention.Primary Funding Source: National Heart, Lung, and Blood Institute. [ABSTRACT FROM AUTHOR]

Unlabelled: Abstract Background: Patient web portals (PWPs) offer patients remote access to their medical record and communication with providers. Adults with health literacy limitations are less likely to access and use health information technology (HIT), including PWPs. In diabetes, PWP use has been associated with patient satisfaction, patient-provider communication, and glycemic control.Methods: Using mixed methods, we explored the relationships between health literacy, numeracy, and computer literacy and the usage of a PWP and HIT. Participants (N=61 adults with type 2 diabetes) attended focus groups and completed surveys, including measures of health literacy, numeracy, and computer anxiety (an indicator of computer literacy) and frequency of PWP and HIT use.Results: Computer literacy was positively associated with health literacy (r=0.41, P<0.001) and numeracy (r=0.35, P<0.001), but health literacy was not associated with numeracy. Participants with limited health literacy (23%), numeracy (43%), or computer literacy (25%) were no less likely to access PWPs or HIT, but lower health literacy was associated with less frequent use of a computer to research diabetes medications or treatments. In focus groups, participants spontaneously commented on family support when accessing and using PWPs or HIT for diabetes management.Conclusions: Participants reported family members facilitated access and usage of HIT, taught them usage skills, and acted as online delegates. Participant statements suggest family members may bridge the HIT "digital divide" in diabetes by helping adults access a PWP or HIT for diabetes management. [ABSTRACT FROM AUTHOR]

Context: Delayed or inaccurate communication between hospital-based and primary care physicians at hospital discharge may negatively affect continuity of care and contribute to adverse events.Objectives: To characterize the prevalence of deficits in communication and information transfer at hospital discharge and to identify interventions to improve this process.Data Sources: MEDLINE (through November 2006), Cochrane Database of Systematic Reviews, and hand search of article bibliographies.Study Selection: Observational studies investigating communication and information transfer at hospital discharge (n = 55) and controlled studies evaluating the efficacy of interventions to improve information transfer (n = 18).Data Extraction: Data from observational studies were extracted on the availability, timeliness, content, and format of discharge communications, as well as primary care physician satisfaction. Results of interventions were summarized by their effect on timeliness, accuracy, completeness, and overall quality of the information transfer.Data Synthesis: Direct communication between hospital physicians and primary care physicians occurred infrequently (3%-20%). The availability of a discharge summary at the first postdischarge visit was low (12%-34%) and remained poor at 4 weeks (51%-77%), affecting the quality of care in approximately 25% of follow-up visits and contributing to primary care physician dissatisfaction. Discharge summaries often lacked important information such as diagnostic test results (missing from 33%-63%), treatment or hospital course (7%-22%), discharge medications (2%-40%), test results pending at discharge (65%), patient or family counseling (90%-92%), and follow-up plans (2%-43%). Several interventions, including computer-generated discharge summaries and using patients as couriers, shortened the delivery time of discharge communications. Use of standardized formats to highlight the most pertinent information improved the perceived quality of documents.Conclusions: Deficits in communication and information transfer at hospital discharge are common and may adversely affect patient care. Interventions such as computer-generated summaries and standardized formats may facilitate more timely transfer of pertinent patient information to primary care physicians and make discharge summaries more consistently available during follow-up care. [ABSTRACT FROM AUTHOR]

The health status of approximately 1 million immigrants in the United States and Israel may have been adversely affected by radiation exposure as a result of the Chernobyl nuclear power plant disaster and cleanup efforts. Many of these immigrants suffer from significant psychological distress, fearing that they have a radiation-induced illness. Based on a review of the literature and our experience from the US National Chernobyl Registry Coordinating Center, we recommend that medical management of these immigrants include routine physical examination, with particular attention to the thyroid gland. Adults should receive regular cancer screening as well as routine blood chemistry tests, thyroid function tests, complete blood cell count, and urinalysis. Children should be examined regularly, with attention to the thyroid and overall body growth. It is reasonable for children to undergo thyroid studies, a complete blood cell count, or neuropsychiatric testing if there is clinical suspicion of a disorder. Given the long latency period for disease induction by radiation exposure, it is still too early to fully assess and draw conclusions concerning the possible health effects of the Chernobyl disaster, and long-term follow-up of all potentially affected individuals is important. [ABSTRACT FROM AUTHOR]

Objectives: To describe the role of illustrated medication instructions in pharmacy practice, the evidence for their use, and our experience with their implementation.Practice Description: PictureRx is applicable to all pharmacy practice settings.Practice Innovation: PictureRx enables pharmacists to rapidly produce evidence-based, illustrated medication instructions that are well understood by patients of all health literacy levels.Results: PictureRx has been studied in a number of settings. The tool was successfully deployed at a busy outpatient pharmacy and in a medical clinic for the underserved and was pilot tested among elderly community-dwelling Medicare recipients. In each of these settings, PictureRx was received favorably by patients, pharmacists, and other health care providers. It improved patients' satisfaction with the pharmacy and knowledge about their medications. Ongoing research is assessing whether PictureRx enhances medication management among Latinos.Conclusion: PictureRx helps pharmacists address challenges related to low health literacy and can be implemented in a broad range of practice environments. Ongoing research will delineate the extent to which PictureRx reduces health disparities. [ABSTRACT FROM AUTHOR]

Objective: To describe methods for incorporating standardized patients into health literacy training programs. Methods: We discuss aspects of program development that are relatively unique to this educational context. Results: Individuals were recruited to play the role of an average adult with limited health literacy. Methods of recruitment, training, and scenario development are discussed in detail. Conclusions: Standardized patients can be valuable partners for teaching about low-literacy communication skills. Because of shared experiences, both actors and nonactors can effectively play a character with low health literacy. [ABSTRACT FROM AUTHOR]

BACKGROUND The appropriate dose of aspirin to lower the risk of death, myocardial infarction, and stroke and to minimize major bleeding in patients with established atherosclerotic cardiovascular disease is a subject of controversy. METHODS Using an open-label, pragmatic design, we randomly assigned patients with established atherosclerotic cardiovascular disease to a strategy of 81 mg or 325 mg of aspirin per day. The primary effectiveness outcome was a composite of death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke, assessed in a time-to-event analysis. The primary safety outcome was hospitalization for major bleeding, also assessed in a time-to-event analysis. RESULTS A total of 15,076 patients were followed for a median of 26.2 months (interquartile range [IQRJ, 19.0 to 34.9). Before randomization, 13,537 (96.0% of those with available information on previous aspirin use) were already taking aspirin, and 85.3% of these patients were previously taking 81 mg of daily aspirin. Death, hospitalization for myocardial infarction, or hospitalization for stroke occurred in 590 patients (estimated percentage, 7.28%) in the 81-mg group and 569 patients (estimated percentage, 7.51%) in the 325-mg group (hazard ratio, 1.02; 95% confidence interval [CI], 0.91 to 1.14). Hospitalization for major bleeding occurred in 53 patients (estimated percentage, 0.63%) in the 81-mg group and 44 patients (estimated percentage, 0.60%) in the 325-mg group (hazard ratio, 1.18; 95% CI, 0.79 to 1.77). Patients assigned to 325 mg had a higher incidence of dose switching than those assigned to 81 mg (41.6% vs. 7.1%) and fewer median days of exposure to the assigned dose (434 days [IQR, 139 to 737] vs. 650 days [IQR, 415 to 922]). CONCLUSIONS In this pragmatic trial involving patients with established cardiovascular disease, there was substantial dose switching to 81 mg of daily aspirin and no significant differences in cardiovascular events or major bleeding between patients assigned to 81 mg and those assigned to 325 mg of aspirin daily. (Funded by the Patient-Centered Outcomes Research Institute; ADAPTABLE ClinicalTrials.gov number, NCT02697916.) [ABSTRACT FROM AUTHOR]

Objective: The objective of this trial was to determine the feasibility, acceptability, and preliminary effectiveness of sharing audio recordings of primary care visits with older adults with multimorbidity., Methods: We used a two-arm, randomized, controlled, feasibility trial with 3-month follow-up. Patients aged ≥ 65 years-with diabetes and hypertension-were recruited from academic primary care settings in New Hampshire, Tennessee, and Texas. Patients were randomized to receive online access to audio recordings of scheduled visits for three-months or care as usual (after visit summaries). Primary outcomes were acceptability and feasibility assessed using several indicators: acceptabilityrecruitment of 90 patients; recording use; and the Appropriateness of Intervention Measure (AIM; >3), feasibility- retention rate; protocol adherence; and the Feasibility of Intervention Measure (FIM; >3). Interviews were conducted with clinicians (n = 14) and patients (n = 19). Exploratory outcomes included patient activation, satisfaction, adherence, and quality of life., Results: We met recruitment (n = 91) and retention (98 %) targets and exceeded feasibility (Median FIM 4; IQR 3 - 4) and acceptability (Median AIM 4; IQR 3 - 4) metrics. Fidelity to protocol was high (92 %), and 40 of 45 patients (85 %) accessed their recordings. Interviewees noted the benefits of visit recording, including greater recall, understanding, and family engagement. Recording had little perceived impact on the visit interaction, and concerns about visit recording were minimal. Exploratory outcomes revealed better PROMIS Mental Health Scores for patients receiving Audio compared to Usual Care at 3 months: 51.5 (SD 7.7) vs. 47.7 (SD 9.9), P = 0.04., Conclusions: Sharing visit recordings online with older adults is feasible and acceptable. A larger trial is needed to determine the impact of sharing recordings on patient health outcomes., Practice Implications: Recording is a highly scalable approach to supporting older adults and their care partners in managing care. Advances in natural language processing may unlock further opportunities for this innovative strategy., Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to declare. HealthPAL is software developed with NIH funding (R01LM012815) by Dr. Barr and is freely available at GITHUB https://github.com/openrecordings/healthpal; HealthPAL has not been commercialized and Dr. Barr receives no financial incentives or income related to its use., (Copyright © 2024. Published by Elsevier B.V.)

Purpose: This study is to evaluate duration of oocyte cryostorage and association with thaw survival, fertilization, blastulation, ploidy rates, and pregnancy outcomes in patients seeking fertility preservation., Methods: Retrospective cohort study to evaluate clinical outcomes in patients who underwent fertility preservation from 2011 to 2023 via oocyte vitrification for non-oncologic indications. Primary outcome was thaw survival rate. Secondary outcomes included rates of fertilization, blastulation and embryo ploidy, as well asn pregnancy outcomes. Demographic, controlled ovarian stimulation, and laboratory data were collected for each patient. Analyses were conducted using Kruskal-Wallis, Fisher's exact test, or Chi-squared test, as appropriate. A multivariate logistic regression analysis was utilized, and adjusted odds ratios with 95% confidence intervals were calculated using Group A as the reference group., Results: A total of 5995 oocytes met inclusion criteria. These were divided into quartiles based on duration of cryostorage. Group A included oocytes in cryostorage for 0-2 years; Group B, 3-5 years; and Group C, 6-11 years. Significant differences were found when comparing thaw survival (p < 0.0001), fertilization (p = 0.0009), and blastulation rates (p = 0.0002) among groups; however, no significant differences were seen after multivariate GEE regression analysis. No significant differences were seen in rates of euploidy (p = 0.70), live birth (p = 0.81), and clinical pregnancy (p = 0.58) among groups. After analyzing years in cryostorage as a continuous variable and controlling for confounders, duration of cryostorage was not related to odds of thaw, fertilization, blastulation, euploid rates, or pregnancy outcomes., Conclusion: Length of time in cryostorage is not associated with compromised rates of oocyte thaw survival, fertilization, blastulation, ploidy, or pregnancy outcomes., Competing Interests: Declarations. Competing interests: Alan Copperman is the Medical Director of Progyny., (© 2025. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Patients with rectal cancer staged as clinical T2N0 (cT2N0) are recommended to undergo upfront resection. However, when the tumor is subsequently upstaged to pathologic T3N0 (pT3N0), there are no clear guidelines for adjuvant treatment. This study aimed to analyze national trends in adjuvant management and to identify differences in morbidity or survival., Methods: Using the National Cancer Database (2004-2020), adult patients with cT2N0 rectal adenocarcinoma that were upstaged to pT3N0 after resection were identified. The treatment groups included (i) surgery alone, (ii) surgery + postoperative (post-op) chemotherapy alone, (iii) surgery + post-op chemoradiation (CRT), and (iv) surgery + chemotherapy + CRT. Cox proportional hazard models and Kaplan-Meier curves (6-month landmark analysis) were used to compare survival outcomes., Results: The analytic cohort included 800 patients who received the following treatments: surgery alone (496 [60%]), surgery + post-op chemotherapy (139 [17%]), surgery + post-op CRT (137 [15%]), and surgery + chemotherapy + CRT (69 [8%]). Patients who underwent post-op chemotherapy or chemotherapy + CRT had higher rates of poor/undifferentiated tumors (15.7% and 15.4%, respectively) than those who underwent surgery alone (8.8%) (P = .047). Over the study period, surgery alone decreased from 86.7% to 65.6%, with concomitant increases in post-op adjuvant therapy. Post-op chemotherapy (hazard ratio [HR], 0.336; 95% CI, 0.196-0.575) and chemotherapy + CRT (HR, 0.447; 95% CI, 0.231-0.866) remained independently associated with improved overall survival. Of note, 5-year survival was the lowest in the surgery-alone group (62.5%)., Conclusion: Post-op adjuvant regimens, including chemotherapy, were independently associated with improved survival in patients with cT2N0 rectal cancer upstaged to pT3N0. Adjuvant therapy may be underutilized in this setting., (Copyright © 2024 Society for Surgery of the Alimentary Tract. Published by Elsevier Inc. All rights reserved.)

Objectives: Religion and spirituality are important aspects of many physicians and patients' lives and may impact their views of death and the way they interact with terminally ill patients, specifically comfort discussing end-of-life care and death and dying. This study explores the religious and spiritual beliefs of resident physicians, if they affect interactions with their patients and if burnout impedes this interaction., Methods: A 28-item questionnaire was administered to residents and fellows at an urban academic hospital., Results: 65 residents and fellows answered the survey. Religiosity but not spirituality correlated with reported comfort interacting with patients dealing with death or dying. Resident specialty, biological sex and spirituality were not associated with comfort and conversations about religion and end-of-life care. The majority (60%) reported that the pandemic has not affected how they speak to their patients about death and dying. Caring for a higher volume of terminally ill patients was not associated with high levels of burnout though 71% reported increased burnout due to COVID-19., Conclusion: Further research can be done to determine whether additional training or resources should be provided to resident physicians to cope with death and dying in the setting of a pandemic., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Introduction: Risk of stroke is greater in patients with atrial fibrillation. Anticoagulation is effective at decreasing risk, yet 40-50% of eligible patients are not prescribed anticoagulation and seem to have a concerning gap in care quality. This quality improvement initiative implemented a pharmacist-led approach to identify, verify, and close apparent anticoagulation treatment gaps., Methods: We included adult primary care patients with diagnosis of atrial fibrillation; congestive heart failure, hypertension, age ≥75 years (doubled), diabetes, stroke/transient ischemic attack (doubled), vascular disease, age 65-74 years, and sex (female) (CHA2DS2-VASc) score of at least 2, and no current anticoagulant use. We identified patients using claims and electronic health record data and evaluated explanations through chart review and provider contact. A provider outreach protocol was developed and implemented to address opportunities for anticoagulation., Results: Of 242 patients with an apparent gap, 84% had a verified treatment gap. However, 86% of verified treatment gaps were explained through pharmacist chart review and outreach to providers, and they did not require further action. Explanations included spontaneous resolution of atrial fibrillation, patient declining treatment, completion of a procedure to correct atrial fibrillation or mitigate stroke risk, and high bleeding risk., Conclusions: Relying solely on claims- and electronic health record-based algorithms may substantially overestimate gaps in care quality., (Copyright © 2024 National Association for Healthcare Quality.)

Background: The relative contributions of common patient-reported social determinants of health on 30- and 90-day post-discharge outcomes among patients with acute coronary syndromes (ACS) is unclear., Objective: The aim of this article is to examine the independent associations of social determinants with readmission or death, accounting for medical history., Methods: Participants included adults who were hospitalized with ACS at an academic medical center. Domains measured were social support, health literacy/numeracy, and socioeconomic status (SES) (including education and difficulty paying bills). We employed multivariable Cox proportional hazard models to study associations with time to all-cause readmission or death, up to 30 or 90 days after discharge, and adjusted for demographics and medical history (prior admissions and Elixhauser comorbidity index)., Key Results: Among 1,168 patients with ACS and no history of heart failure, more prior admissions, and higher comorbidity index (the medical history domain) were associated with higher rates of 30- and 90-day readmission or death (domain p values <.01 and <.0001, respectively). The social support domain was not associated with outcomes. Higher health literacy and numeracy were associated with lower rates of 30- and 90-day readmission or death (domain p values .016 and .002, respectively). Higher education and less difficulty paying bills (the SES domain) was marginally associated with lower rates of 90-day readmission or death (domain, p = .052)., Conclusions: In addition to medical history, the domain of health literacy and numeracy was independently associated with readmission or death of patients with ACS during the 90 days after hospital discharge. [ HLRP: Health Literacy Research and Practice . 2024;8(4):e212-e223. ]., Competing Interests: Disclosure: ASM has served as a data safety and monitoring board member for the Clinical Science Research and Development Veterans Affairs Merit Grant: Personalizing Veteran Lung Cancer Screening and Diagnosis. RLR has received support for travel through the Engel Research Award from the Academy for Communication in Healthcare; and has received grants from the National Institutes of Health, Patient-Centered Outcomes Research Institute, Agency for Healthcare Research and Quality, Duke Clinical Research Institute/Novartis, Centers for Disease Control and Prevention Global Health Foundation, Centers for Medicare and Medicaid Services/Center for Medicare and Medicaid Innovation, paid to the institution. EEV has received grants from the National Heart, Lung, and Blood Institute and National Institute of Nursing Research (UG3HL165740), and the National Institutes of Health/National Institute on Aging (R01-AG065249), and served on a COVID-19 Advisory Board for Gilead Sciences. LSM has received grants from the National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases through the University of Utah (R01 DK124719), the Helmsley Charitable Trust (R-2203-05822), and the National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases (R01 DK119282 and R01 DK119282-S), paid to the institution. SPB has received grants from the National Institutes of Health/National Institute of Aging (1K23AG048347-A101), National Institutes of Health/Eunice Kennedy Shriver National Institute of Child Health and Human Development (K12-HD043483), paid to the institution. SK has received grants from the National Institutes of Health, Patient-Centered Outcomes Research Institute, Agency for Healthcare Research and Quality, Centers for Medicare and Medicaid Services, and Esperion Therapeutics, paid to the institution; and has served as a consultant to Gilead Sciences and Bayer. The remaining authors have disclosed no potential conflicts of interest, financial or otherwise.

Background: Heart failure (HF) hospitalizations are characterized by vulnerability in functioning and frequent post-discharge healthcare utilization in both acute and post-acute settings., Objective: To determine, in patients hospitalized for decompensated HF, the association of vulnerability with (1) detailed forms of post-discharge healthcare utilization, and (2) days spent away from home after initial hospital discharge., Design: Secondary analysis of a prospective longitudinal cohort study from a single-center academic institution in the USA., Participants: Adults admitted with acute decompensated HF who were discharged alive., Main Measures: The Vulnerable Elders Survey 13 (VES-13) measured functional vulnerability at baseline. The primary outcome was the Highest Healthcare Utilization (HHU) 90 days post-discharge, from the following ordered categories: at home, emergency room visit, skilled nursing facility stay, hospital readmission, or death. The secondary outcome was the proportion of days not at home (DNAH) within the first 90 days. Analyses were performed using a partial proportional odds model with adjustment for demographics and health characteristics., Key Results: A total of 806 patients were included with median age 65, interquartile range [IQR] 55-73 years. Fewer than half (N = 345 [43%]) of patients remained alive and at home during 90-day follow-up. There were 286 [35%] hospital readmissions and 70 [8.7%] participants died. The median DNAH was 3 [IQR 0-16]. Increased vulnerability was associated with (1) HHU, (2) higher odds of utilizing healthcare or dying versus being at home alive 90 days post-discharge (OR 1.81 [95% CI, 1.35, 2.42]), and (3) higher odds of DNAH in the first 90 days (OR 1.55 [95% CI, 1.27, 1.89])., Conclusions: In this cohort of patients hospitalized for decompensated HF, vulnerability predicted higher levels of healthcare utilization, as well as total days not at home in the 90 days following hospitalization. Vulnerability may have clinical applications to identify patients at greatest need for comprehensive, patient-centered discharge planning., (© 2024. The Author(s).)

Importance: Pragmatic randomized clinical trials (RCTs) often use multiple data sources to examine clinical events, but the relative contribution of data sources to clinical end-point rates is understudied., Objective: To assess the contribution of data sources (electronic health records [EHRs], public/private insurance claims, and/or participant-reported data) to clinical end points among ADAPTABLE participants who had available data., Design, Setting, and Participants: The ADAPTABLE study was an open-label, pragmatic RCT from April 2016 through June 2019 conducted in research networks within clinical practice. Participants had existing atherosclerotic cardiovascular disease and available data to analyze. The characteristics of patients by combinations of data source availability were compared to examine the contribution of each of the data sources to end-point ascertainment. Data for this prespecified analysis were examined from January 2022 to June 2023., Exposures: Randomized exposure to 81 mg or 325 mg of aspirin daily., Main Outcomes and Measures: Number of events for the primary end point (composite of death, hospitalization for myocardial infarction, and hospitalization for stroke) that were contributed by EHR or claims data and then number of events contributed by each additional data source., Results: Of 15 006 participants randomized with at least 1 other source of data available beyond participant-reported data, there were 8756 (58.3%) with participant-reported and EHR data; 4291 (28.6%) with participant-reported, EHR, and claims data; 1412 (9.4%) with EHR-only data; 262 (1.7%) with participant-reported and claims data; 202 (1.3%) with EHR and claims data; and 83 (0.6%) with claims-only data. Participants with EHR-only data were younger (median age, 63.7 years; IQR, 55.8-71.4) compared with the other groups (range, 65.6-71.9 years). Among participants with both EHR and claims data, with or without participant-reported data (n = 4493), for each outcome, most events (92%-100%) were identified in the EHR or in claims data. For all clinical end points, participant-reported data contributed less than 10% of events not otherwise available from claims or EHR data., Conclusions and Relevance: In this analysis of a pragmatic RCT, claims and EHR data provided the most clinical end-point data when compared with participant-reported events. These findings provide a framework for collecting end points in pragmatic clinical trials. Further work is needed to understand the data source combinations that most effectively provide clinical end-point data in RCTs.

Importance: Atherosclerotic cardiovascular disease (ASCVD) remains the leading cause of morbidity and mortality in the US. Although aspirin is recommended for secondary prevention of ASCVD, there was no difference in safety and effectiveness of aspirin dosed daily at 81 mg or 325 mg in the ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) randomized clinical trial. However, it is unknown whether differences by sex exist in the safety and effectiveness of the different aspirin doses., Objective: To evaluate sex-specific differences in the safety and effectiveness of 2 aspirin doses in the ADAPTAPLE trial., Design, Setting, and Participants: The ADAPTABLE study was an open-label, pragmatic, randomized clinical trial that randomly assigned participants with chronic, stable ASCVD to 81 mg vs 325 mg of aspirin daily. Using Cox proportional-hazard models, male and female participants were compared for outcomes. In addition, it was assessed whether sex was an effect modifier in the association between aspirin dose and outcomes. The ADAPTABLE trial was conducted at 40 medical centers and 1 health plan. Eligible patients were 18 years and older and had established ASCVD. Study data were analyzed from December 2021 to March 2024., Interventions: Patients received 81 mg or 325 mg of aspirin daily for the secondary prevention of ASCVD., Main Outcomes and Measures: The primary effectiveness outcomes included all-cause death and hospitalization for myocardial infarction (MI) or stroke. The primary safety outcome was hospitalization for major bleeding requiring transfusion., Results: A total of 15 076 patients (median [IQR] age, 67.6 [60.7-73.6] years; 10 352 male [68.7%]) were followed up for a median (IQR) of 26.2 (19.0-34.9) months. Overall, 4724 (31.3%) were female, and 2307 of the female participants (48.8%) received aspirin 81 mg. Compared with males, female participants were younger (median [IQR] age, 66.3 [59.4-72.6] years vs 68.2 (61.4-73.9) years, less likely to self-report White race (3426 [72.5%] vs 8564 [82.7%]), more likely to smoke (564 [12.9%] vs 818 [8.4%]), and more likely to have a history of peripheral arterial disease (1179 [25.7%] vs 2314 [23.0%]). The primary effectiveness outcome of all-cause death and hospitalization for MI or stroke occurred in 379 female participants (8.1%) and 780 male participants (7.1%). There was no significant interaction by sex for the primary effectiveness end point between the 2 aspirin doses (female adjusted hazard ratio [aHR], 1.01; 95% CI, 0.82-1.26 and male aHR, 1.06; 95% CI, 0.91-1.23; P interaction term for sex = .74). During the trial, female participants had fewer revascularization procedures (237 [5.0%] vs 680 [6.6%]; aHR, 0.79; 95% CI, 0.68-0.92; P = .002) but had a higher risk of hospitalization for stroke (aHR, 1.72; 95% CI, 1.27-2.33; P < .001). Among female participants, there was a slightly higher rate of bleeding in the 81-mg aspirin cohort compared with the 325-mg cohort (20 [0.83%] vs 13 [0.52%]; aHR, 2.21; 95% CI, 1.04-4.70; P interaction term for sex = .07). There were no significant differences between female and male participants regarding aspirin dose adherence., Conclusions and Relevance: In this secondary analysis of the ADAPTABLE trial, there were no significant sex-specific differences in the effectiveness and safety of 2 aspirin doses for secondary prevention of ASCVD events., Trial Registration: ClinicalTrials.gov Identifier: NCT02697916.

Objectives: To evaluate whether the effectiveness and safety of low (81 mg daily) versus high-dose (325 mg daily) aspirin is consistent across races among patients with established atherosclerotic cardiovascular disease (ASCVD)., Design: A secondary analysis of the randomised controlled trial ADAPTABLE was performed., Setting: The study was conducted in 40 centres and one health plan participating in the National Patient-Centred Clinical Research Network (PCORnet) in the USA., Participants: Among 15 076 participants with established ASCVD, 14 096 had self-reported race available and were included in the analysis. Participants were divided according to self-reported race as Black (n=1311, 9.3%), White (n=11 990, 85.1%) or other race (n=795, 5.6%)., Interventions: Participants were randomised to open-label daily aspirin doses of 81 mg versus 325 mg in a 1:1 ratio for a median of 26.2 months., Primary and Secondary Outcomes Measures: The primary effectiveness endpoint was a composite of death from any cause, hospitalisation for myocardial infarction or hospitalisation for stroke. The primary safety endpoint was hospitalisation for bleeding requiring blood product transfusion., Results: Estimated cumulative incidence of the primary effectiveness endpoint at median follow-up with the 81 mg and the 325 mg daily doses were 6.70% and 7.12% in White participants (adjusted HR: 1.00 [95% CI: 0.88 to 1.15]); 12.27% and 10.69% in Black participants (adjusted HR: 1.40 [95% CI: 1.02 to 1.93]); and 6.88% and 7.69% in other participants (adjusted HR: 0.86 [95% CI: 0.54 to 1.39]) (p-interaction=0.12), respectively. There was no significant interaction between self-reported race and assigned aspirin dose regarding the secondary effectiveness and the primary safety endpoints., Conclusion: Race is not an effect modifier on the impact of aspirin dosing on effectiveness and safety in patients with established ASCVD. In clinical practice, treatment decisions regarding aspirin dose in secondary prevention of ASCVD should not be influenced by race., Trial Registration Number: NCT02697916., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Automated text messaging is a promising approach to monitor patients after hospital discharge and avert readmissions; however, it is not known to what extent patients would engage with this type of program and whether engagement may vary based on patients' characteristics. Using data from a 30-day postdischarge texting program at a large university hospital, we examined engagement over time (operationalized as response rate to text messages) and patient characteristics associated with engagement. Of the 1324 patients in the study sample, 838 (63%) stayed in the program for the full duration. Among those retained, the median response rate was 33% (interquartile range: 11%-77%) and decreased over time. Patients who were male (p < .05), were Black/African American (p < .001), had lower health literacy (p < .01), or had not recently logged into the patient portal (p < .001), all had lower response rates. Results support closer examinations of patient engagement in hospital-based texting programs and who is positioned to benefit., (© 2024 The Authors. Journal of Hospital Medicine published by Wiley Periodicals LLC on behalf of Society of Hospital Medicine.)

Background: Hospital readmission is common among patients with heart failure. Vulnerability to decline in physical function may increase the risk of noncardiovascular readmission for these patients, but the association between vulnerability and the cause of unplanned readmission is poorly understood, inhibiting the development of effective interventions., Objectives: We examined the association of vulnerability with the cause of readmission (cardiovascular vs. noncardiovascular) among hospitalized patients with acute decompensated heart failure., Designs, Settings, and Participants: This prospective longitudinal study is part of the Vanderbilt Inpatient Cohort Study., Main Outcome and Measures: The primary outcome was the cause of unplanned readmission (cardiovascular vs. noncardiovascular). The primary independent variable was vulnerability, measured using the Vulnerable Elders Survey (VES-13)., Results: Among 804 hospitalized patients with acute decompensated heart failure, 315 (39.2%) experienced an unplanned readmission within 90 days of discharge. In a multinomial logistic model with no readmission as the reference category, higher vulnerability was associated with readmission for noncardiovascular causes (relative risk ratio [RRR] = 1.36, 95% confidence interval [CI]: 1.06-1.75) in the first 90 days after discharge. The VES-13 score was not associated with readmission for cardiovascular causes (RRR = 0.94, 95% CI: 0.75-1.17)., Conclusions: Vulnerability to functional decline predicted noncardiovascular readmission risk among hospitalized patients with heart failure. The VES-13 is a brief, validated, and freely available tool that should be considered in planning care transitions. Additional work is needed to examine the efficacy of interventions to monitor and mitigate noncardiovascular concerns among vulnerable patients with heart failure being discharged from the hospital., (© 2024 Society of Hospital Medicine.)

Background: In patients with atherosclerotic cardiovascular disease, increasing age is concurrently associated with higher risks of ischemic and bleeding events. The objectives are to determine the impact of aspirin dose on clinical outcomes according to age in atherosclerotic cardiovascular disease., Methods and Results: In the ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) trial, patients with atherosclerotic cardiovascular disease were randomized to daily aspirin doses of 81 mg or 325 mg. The primary effectiveness end point was death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke. The primary safety end point was hospitalization for bleeding requiring transfusion. A total of 15 076 participants were randomized to aspirin 81 mg (n=7540) or 325 mg (n=7536) daily (median follow-up: 26.2 months; interquartile range: 19.0-34.9 months). Median age was 67.6 years (interquartile range: 60.7-73.6 years). Among participants aged <65 years (n=5841 [38.7%]), a primary end point occurred in 226 (7.54%) in the 81 mg group, and in 191 (6.80%) in the 325 mg group (adjusted hazard ratio [HR], 1.23 [95% CI, 1.01-1.49]). Among participants aged ≥65 years (n=9235 [61.3%]), a primary end point occurred in 364 (7.12%) in the 81 mg group, and in 378 (7.96%) in the 325 mg group (adjusted HR, 0.95 [95% CI, 0.82-1.10]). The age-dose interaction was not significant ( P =0.559). There was no significant interaction between age and the randomized aspirin dose for the secondary effectiveness and the primary safety bleeding end points ( P >0.05 for all)., Conclusions: Age does not modify the impact of aspirin dosing (81 mg or 325 mg daily) on clinical end points in secondary prevention of atherosclerotic cardiovascular disease.

Objective: Patients with diabetes mellitus (DM) and concomitant atherosclerotic cardiovascular disease (ASCVD) must be on the most effective dose of aspirin to mitigate risk of future adverse cardiovascular events., Research Design and Methods: ADAPTABLE, an open-label, pragmatic study, randomized patients with stable, chronic ASCVD to 81 mg or 325 mg of daily aspirin. The effects of aspirin dosing was assessed on the primary effectiveness outcome, a composite of all-cause death, hospitalization for myocardial infarction, or hospitalization for stroke, and the primary safety outcome of hospitalization for major bleeding. In this prespecified analysis, we used Cox proportional hazards models to compare aspirin dosing in patients with and without DM for the primary effectiveness and safety outcome., Results: Of 15,076 patients, 5,676 (39%) had DM of whom 2,820 (49.7%) were assigned to 81 mg aspirin and 2,856 (50.3%) to 325 mg aspirin. Patients with versus without DM had higher rates of the composite cardiovascular outcome (9.6% vs. 5.9%; P < 0.001) and bleeding events (0.78% vs. 0.50%; P < 0.001). When comparing 81 mg vs. 325 mg of aspirin, patients with DM had no difference in the primary effectiveness outcome (9.3% vs. 10.0%; hazard ratio [HR] 0.98 [95% CI 0.83-1.16]; P = 0.265) or safety outcome (0.87% vs. 0.69%; subdistribution HR 1.25 [95% CI 0.72-2.16]; P = 0.772)., Conclusions: This study confirms the inherently higher risk of patients with DM irrespective of aspirin dosing. Our findings suggest that a higher dose of aspirin yields no added clinical benefit, even in a more vulnerable population., (© 2023 by the American Diabetes Association.)