Search

Two randomized controlled trials demonstrated no clinical benefit of hydroxychloroquine (HCQ) for either postexposure prophylaxis or early treatment of SARS-CoV-2 infection. Using data from these studies, we calculated the time-weighted average change from baseline SARS-CoV-2 viral load and demonstrated that HCQ did not affect viral clearance.

Medicaid expansion has led to earlier stage diagnoses in several cancers but has not been studied in hepatocellular carcinoma (HCC), a disease with complex risk factors. We examined the effect of Medicaid expansion on the diagnosis of HCC and associations with county-level social vulnerability.Patients with HCC65 years of age were identified from the SEER database (2010-2016). County-level social vulnerability factors were obtained from the CDC SVI and BRFSS. A Difference-in-Difference analysis evaluated change in early-stage diagnoses (stage I-II) between expansion and non-expansion states. A Difference-in-Difference-in-Difference analysis evaluated expansion impact among counties with higher proportions of social vulnerability.Of 19,751 patients identified, 81.5% were in expansion states. Uninsured status decreased in expansion states (6.3%-2.4%, p 0.0001) and remained unchanged in non-expansion states (12.7%-14.8%, p = 0.43). There was no significant difference in the incidence of early-stage diagnoses between expansion states and non-expansion states. Results were consistent when accounting for social vulnerability.Medicaid expansion was not associated with earlier stage diagnoses in patients with HCC, including those with higher social vulnerability. Unlike other cancers, expanded access did not translate into higher utilization of care in HCC, suggesting barriers on a multitude of levels.

Shared decision making (SDM) may result in treatment plans that best reflect the goals and wishes of patients, increasing patient satisfaction with the decision-making process. There is a knowledge gap to support the use of decision aids in SDM for anticoagulation therapy in patients with atrial fibrillation (AF). We describe the development and testing of a new decision aid, including a multicenter, randomized, controlled, 2-arm, open-label ENHANCE-AF clinical trial (Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AF Stroke Prevention) to evaluate its effectiveness in 1,200 participants.Participants will be randomized to either usual care or to a SDM pathway incorporating a digital tool designed to simplify the complex concepts surrounding AF in conjunction with a clinician tool and a non-clinician navigator to guide the participants through each step of the tool. The participant-determined primary outcome for this study is the Decisional Conflict Scale, measured at 1 month after the index visit during which a decision was made regarding anticoagulation use. Secondary outcomes at both 1 and 6 months will include other decision making related scales as well as participant and clinician satisfaction, oral anticoagulation adherence, and a composite rate of major bleeding, death, stroke, or transient ischemic attack. The study will be conducted at four sites selected for their ability to enroll participants of varying racial and ethnic backgrounds, health literacy, and language skills. Participants will be followed in the study for 6 months.The results of the ENHANCE-AF trial will determine whether a decision aid facilitates high quality shared decision making in anticoagulation discussions for stroke reduction in AF. An improved shared decision-making experience may allow patients to make decisions better aligned with their personal values and preferences, while improving overall AF care.

Background Using antibiotics without a prescription is potentially unsafe and may increase the risk of antimicrobial resistance. We evaluated the effect of patient, health system, and clinical encounter factors on intention to use antibiotics without a prescription that were (1) purchased in the United States, (2) obtained from friends or relatives, (3) purchased abroad, or (4) from any of these sources. Methods The survey was performed January 2020–June 2021 in 6 publicly funded primary care clinics and 2 private emergency departments in Texas, United States. Participants included adult patients visiting 1 of the clinical settings. Nonprescription use was defined as use of antibiotics without a prescription; intended use was professed intention for future nonprescription antibiotic use. Results Of 564 survey respondents (33% Black and 47% Hispanic or Latino), 246 (43.6%) reported prior use of antibiotics without a prescription, and 177 (31.4%) reported intent to use antibiotics without a prescription. If feeling sick, respondents endorsed that they would take antibiotics obtained from friends/relatives (22.3% of 564), purchased in the United States without a prescription (19.1%), or purchased abroad without a prescription (17.9%). Younger age, lack of health insurance, and a perceived high cost of doctor visits were predictors of intended use of nonprescription antibiotics from any of the sources. Other predictors of intended use were lack of transportation for medical appointments, language barrier to medical care, Hispanic or Latino ethnicity, and being interviewed in Spanish. Conclusions Patients without health insurance who report a financial barrier to care are likely to pursue more dangerous nonprescription antimicrobials. This is a harm of the US fragmented, expensive healthcare system that may drive increasing antimicrobial resistance and patient harm.

Background The coronavirus disease 2019 (COVID-19) pandemic has challenged researchers performing clinical trials to develop innovative approaches to mitigate infectious risk while maintaining rigorous safety monitoring. Methods In this report we describe the implementation of a novel exclusively remote randomized clinical trial (ClinicalTrials.gov NCT04354428) of hydroxychloroquine and azithromycin for the treatment of the SARS-CoV-2–mediated COVID-19 disease which included cardiovascular safety monitoring. All study activities were conducted remotely. Self-collected vital signs (temperature, respiratory rate, heart rate, and oxygen saturation) and electrocardiographic (ECG) measurements were transmitted digitally to investigators while mid-nasal swabs for SARS-CoV-2 testing were shipped. ECG collection relied on a consumer device (KardiaMobile 6L, AliveCor Inc.) that recorded and transmitted six-lead ECGs via participants’ internet-enabled devices to a central core laboratory, which measured and reported QTc intervals that were then used to monitor safety. Results Two hundred and thirty-one participants uploaded 3245 ECGs. Mean daily adherence to the ECG protocol was 85.2% and was similar to the survey and mid-nasal swab elements of the study. Adherence rates did not differ by age or sex assigned at birth and were high across all reported race and ethnicities. QTc prolongation meeting criteria for an adverse event occurred in 28 (12.1%) participants, with 2 occurring in the placebo group, 19 in the hydroxychloroquine group, and 7 in the hydroxychloroquine + azithromycin group. Conclusions Our report demonstrates that digital health technologies can be leveraged to conduct rigorous, safe, and entirely remote clinical trials.

Background Use of antibiotics without a prescription (purchased in the United States (U.S.), purchased in other countries, or obtained from friends and relatives) is potentially unsafe and may increase the global risk of antimicrobial resistance. We evaluated the effect of patient, health system, and clinical encounter factors on intention to use antibiotics without a prescription. Methods Waiting room survey conducted from January 2020 and March 2021 in three continuity and three same-day public primary care clinics and two private emergency departments. Non-prescription use was defined as the consumption of antibiotics not prescribed for the individual’s current condition. Intended use was defined as professed intention to take antibiotics if feeling sick, without contacting a doctor, nurse, or clinic, in any of the following situations: 1) buying antibiotics without a prescription in the U.S., 2) buying antibiotics without a prescription in another country, and 3) getting antibiotics from friends or relatives. The effect of patient, health care system, and clinical encounter factors were studied using multivariate logistic regression. Results Of the 564 respondents, 247 (43.8%) reported prior use of non-prescription antibiotics; half of these instances involved penicillins (mostly amoxicillin). Overall, 177 (31.4%) of the respondents intended to use antibiotics without a prescription from one of the three sources (Figure 1). Younger age, lack of health insurance and high cost of doctor visits were predictors of intention to buy antibiotics without a prescription in the U.S. (Table 1). Predictors of intention to buy antibiotics without a prescription from other countries included younger age, being interviewed in Spanish, and reporting that a language barrier is a major problem for medical appointments. Lack of health insurance and high cost of physician visits were associated with the intention to use antibiotics obtained from relatives or friends. Conclusion Interventions aimed at reducing non-prescription antibiotic use should focus on addressing language barriers, ensuring health insurance coverage, and reducing financial barriers to primary care visits. Disclosures Larissa Grigoryan, MD, PhD, Rebiotix Inc: Grant/Research Support Michael K. Paasche-Orlow, MD, MPH, GlaxoSmithKline: Advisor/Consultant Barbara Trautner, MD, PhD, Genetech: Advisor/Consultant.

Background The use of antibiotics obtained without a prescription (non-prescription use) in the United States (U.S.) may contribute to antimicrobial resistance. We hypothesized that among Hispanic/Latino patients, the intention to use non-prescription antibiotics would be associated with: [1] lower acculturation (preference to socialize with Hispanic/Latinos) and [2] having friends or relatives who use antibiotics without contacting a doctor (social norms). Methods We conducted a survey on the factors that impact Hispanic/Latino patients’ decisions to use non-prescription antibiotics in safety-net primary care clinics and private emergency departments in the greater Houston, Texas area between January 2020 and June 2021. Surveys were read to patients in English or Spanish and queried patient, health system, and clinical encounter factors. Results Of 263 Hispanic/Latino patients, 59% completed the survey in Spanish and 41% in English (Table 1). Overall, 47% reported previous non-prescription antibiotic use, and 36% professed intention to hypothetically obtain and use non-prescription antibiotics, if feeling sick, from one or more of three sources (bought without a prescription in the U. S., from another country, and from friends or relatives). Lack of health insurance, being surveyed in Spanish, having friends or relatives who use antibiotics without consulting a doctor, and high cost of doctor visits were predictors of intent to use antibiotics bought without a prescription in the U.S. (Table 2). Predictors of intent to use non-prescription antibiotics from other countries included lower acculturation scores (preferring to socialize with Hispanics/Latinos), younger age, having friends or relatives who use antibiotics without consulting a doctor, and reported language barriers to medical appointments. Predictors of intent to use antibiotics from friends and relatives included having friends or relatives who use antibiotics without consulting a doctor, and high cost of doctor visits. Conclusion Interventions aimed at reducing non-prescription use in the Hispanic/Latino community should focus on ensuring affordable language concordant healthcare and promoting antibiotic stewardship as a social norm. Disclosures Barbara Trautner, MD, PhD, Genetech: Advisor/Consultant Michael K. Paasche-Orlow, MD, MPH, GlaxoSmithKline: Advisor/Consultant Larissa Grigoryan, MD, PhD, Rebiotix Inc: Grant/Research Support.

OBJECTIVE: Guidelines recommend emergency medical services (EMS) patients to be transported to the nearest appropriate emergency department (ED). Our objective was to estimate the prevalence of EMS transport to an ED other than the nearest ED (“potential bypassing”). DATA SOURCES: Illinois Prehospital Patient Care Report Data of EMS transports (July 2019 to December 2019). DATA COLLECTION/EXTRACTION METHODS: We identified all EMS ground transports with an advanced life‐support (ALS) paramedic to an ED for patients aged 21 years and older. Using street address of incident location, we performed geocoding and driving route analyses and obtained estimated driving distance and time to the destination ED and alternative EDs. MAIN OUTCOME AND MEASURES: Our main outcomes were dichotomous indicators of potential bypassing of the nearest ED based on distance and time. As secondary outcomes we examined potential bypassing indicators based on excess driving distance and time. STUDY DESIGN: We used Poisson regression models to obtain adjusted relative rates of potential bypassing indicators by acuity level, primary impression, patient demographics and geographic characteristics. PRINCIPAL FINDINGS: Our study cohort of 361,051 EMS transports consisted of 5.8% critical, 37.2% emergent and 57.0% low acuity cases transported to 222 EDs. The observed rate of potential bypassing was approximately 34% of cases for each acuity level. Treating the cardiovascular primary impression code group as the reference case, we found small to no differences in potential bypassing rates across other primary impression code groups of all acuity levels, with the exception of critical acuity trauma cases for which potential bypassing rate was 64% higher (incidence rate ratio = 1.64, 95% confidence interval, 1.54–1.74). Compared to zip codes with one ED within a 5‐mile vicinity, potential bypassing was higher in areas with no ED or multiple EDs within a 5‐mile vicinity. CONCLUSION: Approximately one‐third of EMS transports potentially bypassed the nearest ED. EMS transport destination may be motivated by factors other than proximity.

Background: Electronic health records (EHRs) may help enable reliable, rapid data management for many uses, such as facilitating communication of advance care planning (ACP). However, issues with validity and accuracy of EHRs hinder the use of ACP information for practical applications. Design: We present a cross-sectional pilot study of 433 older adults with cancer from three large health care systems, participating in an ongoing multisite pragmatic trial (4UH3AG060626-02). We compared data extracted from dedicated structured EHR fields for ACP to a chart review of corresponding ACP documentation contained in the medical chart. Results: Structured ACP data existed for 43.2% of patients and varied by site (25.7% −48.9%). Of the identified structured ACP data elements, 59.2% of recorded elements were correct, 23.7% were incorrect, and 17.1% were duplicates with heterogeneity across sites. Conclusion: Structured ACP data in EHRs were frequently incorrect. This represents a problem for patients and their families, as well as quality improvement and research efforts. Clinical Trials Registration: NCT03609177.

Study Objective To characterize the short-term incidence of gynecologic cancer after undergoing uterine artery embolization (UAE). Design Retrospective cohort study. Setting Commercial insurance claims database. Patients Total of 15 393 United States women aged 18 to 64 years who underwent UAE between 2007 and 2017. Interventions We used the IBM MarketScan (Armonk, NY) claims to identify adult women without previous gynecologic cancer diagnoses undergoing UAE between 2007 and 2017. Database queries identified women with any diagnostic or procedure codes related to gynecologic malignancies occurring in the first 3 years after UAE. A malignancy diagnosis was suggested by recurrent malignancy-related claims not linked exclusively to diagnostic testing (e.g., transvaginal ultrasound) and malignancy codes linked to tissue pathology claims. Incidence of malignancy diagnosis was calculated. Rates of endometrial sampling in the year before UAE were identified. Measurements and Main Results Thirty-one women undergoing UAE had gynecologic cancer diagnoses within 3 years of the procedure (22 of 31, 71% uterine cancers; 7 of 31, 23% ovarian cancers; and 2 of 31, 6% cervical cancers). On average, cancer diagnoses were made 1.1 ± 0.9 years after UAE. One in 497 women undergoing UAE was diagnosed with a gynecologic malignancy within 3 years, with an incidence of 1.1 malignancies per 1000 person-years. Cancer incidence increased with age at the time of UAE: short-term malignancy diagnoses were made in 1 in 377 women aged 45 to 54 years, and 1 in 79 women aged 55 to 64 years. In the year before UAE, 28% (4311 of 15 362) of women without cancer, and 23% (5 of 22) of women diagnosed with uterine cancer had preprocedural endometrial sampling. Conclusion These data can inform risk/benefit counseling and shared decision-making regarding UAE and its alternatives. Short-term malignancies after UAE highlight the importance of preprocedure evaluation in symptomatic women and women with age-related risk.

OBJECTIVES: This study is a randomized controlled trial comparing the efficacy of a virtual counselor (VICKY) to the My Family Health Portrait (MFHP) tool for collecting family health history (FHx). METHODS: A total of 279 participants were recruited from a large safety-net hospital and block randomized by health literacy to use one of the digital FHx tools, followed by a genetic counselor interview. A final sample of 273 participants were included for analyses of primary study aims pertaining to tool concordance, which assessed agreement between tool and genetic counselor. RESULTS: Tool completion differed significantly between tools (VICKY=97%, MFHP=51%; p