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ObjectiveTo explore trends in blood pressure (BP) control before and during the COVID-19 pandemic.Patients and methodsHealth systems participating in the National Patient-Centered Clinical Research Network (PCORnet) Blood Pressure Control Laboratory Surveillance System responded to data queries, producing 9 BP control metrics. Averages of the BP control metrics (weighted by numbers of observations in each health system) were calculated and compared between two 1-year measurement periods (January 1, 2019, through December 31, 2019, and January 1, 2020, through December 31, 2020).ResultsAmong 1,770,547 hypertensive persons in 2019, BP control to

SARS-CoV-2 antibody levels associated with reduced hospitalization risk remain undefined. Our outpatient COVID-19 convalescent plasma (CCP), placebo-controlled trial observed SARS-CoV-2 antibody levels decreasing 22-fold from matched donor units into post-transfusion seronegative recipients. Unvaccinated recipients were jointly stratified by a) early or late transfusion (≤ 5 or >5 days from symptom onset) and b) high or low post-transfusion SARS-CoV-2 antibody levels (< or ≥ geometric mean). Early treatment with high post-transfusion antibody levels reduced hospitalization risk-0/102 (0%) compared to all other CCP recipients-17/370 (4.6%; Fisher exact p=0.03) and to all control plasma recipients-35/461 (7.6%; Fisher exact p=0.001). A similar donor upper/lower antibody level and early late transfusion stratified analyses indicated significant hospital risk reduction. Pre-transfusion nasal viral loads were similar in CCP and control recipients regardless of hospitalization outcome. Therapeutic CCP should comprise the upper 30% of donor antibody levels to provide effective outpatient use for immunocompromised and immunocompetent outpatients.

Polyclonal convalescent plasma may be obtained from donors who have recovered from coronavirus disease 2019 (Covid-19). The efficacy of this plasma in preventing serious complications in outpatients with recent-onset Covid-19 is uncertain.In this multicenter, double-blind, randomized, controlled trial, we evaluated the efficacy and safety of Covid-19 convalescent plasma, as compared with control plasma, in symptomatic adults (≥18 years of age) who had tested positive for severe acute respiratory syndrome coronavirus 2, regardless of their risk factors for disease progression or vaccination status. Participants were enrolled within 8 days after symptom onset and received a transfusion within 1 day after randomization. The primary outcome was Covid-19-related hospitalization within 28 days after transfusion.Participants were enrolled from June 3, 2020, through October 1, 2021. A total of 1225 participants underwent randomization, and 1181 received a transfusion. In the prespecified modified intention-to-treat analysis that included only participants who received a transfusion, the primary outcome occurred in 17 of 592 participants (2.9%) who received convalescent plasma and 37 of 589 participants (6.3%) who received control plasma (absolute risk reduction, 3.4 percentage points; 95% confidence interval, 1.0 to 5.8; P = 0.005), which corresponded to a relative risk reduction of 54%. Evidence of efficacy in vaccinated participants cannot be inferred from these data because 53 of the 54 participants with Covid-19 who were hospitalized were unvaccinated and 1 participant was partially vaccinated. A total of 16 grade 3 or 4 adverse events (7 in the convalescent-plasma group and 9 in the control-plasma group) occurred in participants who were not hospitalized.In participants with Covid-19, most of whom were unvaccinated, the administration of convalescent plasma within 9 days after the onset of symptoms reduced the risk of disease progression leading to hospitalization. (Funded by the Department of Defense and others; CSSC-004 ClinicalTrials.gov number, NCT04373460.).

Despite evidence of their effectiveness, free smoking quitlines are underused. The best way to educate providers about and encourage use of quitlines is not established. We examined if electronic medical record (EMR)-integrated best practices alerts (BPAs) with or without additional provider education resulted in increased quitline referrals.Waitlist-controlled, cluster-randomized trial of primary care practices assigned to three arms. Providers in participating sites received a new EMR-based BPA for quitline referral and additional education outreach visits, the BPA alone, or usual care. The study was conducted in 2 phases: phase 1 from April 17 to October 16, 2017, and phase 2 from November 9, 2017, to May 8, 2018. In phase 2, the usual-care sites were randomized to either of the two intervention arms. The unit of randomization was primary care practice site. All in-office, primary care provider visits with smokers were included. The primary outcome was referral to the quitline. Secondary outcomes included patient acceptance and enrollment in quitline services.Twenty-two practice sites were enrolled. Smoking prevalence at sites ranged from 4.4 to 23%. In phase 1, the BPA-plus-education arm had 5636 eligible encounters and 405 referrals (referral rate 7.2%) while the BPA-only arm had 6857 eligible encounters and 623 referrals (referral rate 9.1%). The usual-care arm had 7434 encounters but no referrals. Comparing the BPA-plus arm to the BPA-only arm, the odds ratio of referral was 0.76 (CI 0.3-1.8). In phase 2, the combined BPA-plus-education sites had 8516 eligible encounters and 475 referrals (rate 5.6%). The BPA-only sites had 9134 eligible encounters and 470 referrals (rate 5.2%). The odds ratio comparing the 2 groups in phase 2 was 1.06 (0.5-2.2).An EMR-based BPA can improve the number of referrals to quitline services, though more work is needed to improve providers' use of quitlines and low patient acceptance of services. Trial Registration NIH Clinicaltrials.gov identifier: NCT03229356.

Background New considerations during the ethical review processes may emerge from innovative, yet unfamiliar operational methods enabled in pragmatic randomized controlled trials (RCT), potentially making institutional review board (IRB) evaluation more complex. In this manuscript, key components of the pragmatic “Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE)” randomized trial that required a reappraisal of the IRB submission, review, and approval processes are discussed. Main text ADAPTABLE is a pragmatic, multicenter, open-label RCT evaluating the comparative effectiveness of two doses of aspirin widely used for secondary prevention (81 mg and 325 mg) in 15,000 patients with an established history of atherosclerotic cardiovascular disease. The electronic informed consent form is completed online by the participants at the time of enrollment, and endpoint ascertainment is conducted through queries of electronic health records. IRB challenges encountered regarding centralized IRB evaluation, electronic informed consent, patient engagement, and risk determination in ADAPTABLE are described in this manuscript. The experience of ADAPTABLE encapsulates how pragmatic protocol components intended to facilitate the study conduct have been tempered by unexpected, yet justified concerns raised by local IRBs. How the lessons learned can be applied to future similar pragmatic trials is delineated. Conclusion Development of engaging communication channels between IRB and study personnel in pragmatic randomized trials as early as at the time of protocol design allows to reduce issues with IRB approval. Integrations of the lessons learned in ADAPTABLE regarding the IRB process for centralized IRBs, informed consent, patient engagement, and risk determination can be emulated and will be instrumental in future pragmatic studies.

As the nation seeks to recruit and retain physician-scientists, gaps remain in understanding and addressing mitigatable challenges to the success of faculty from underrepresented minority (URM) backgrounds. The Doris Duke Charitable Foundation Fund to Retain Clinical Scientists program, implemented in 2015 at 10 academic medical centers in the United States, seeks to retain physician-scientists at risk of leaving science because of periods of extraordinary family caregiving needs, hardships that URM faculty-especially those who identify as female-are more likely to experience. At the annual Fund to Retain Clinical Scientists program directors conference in 2018, program directors-21% of whom identify as URM individuals and 13% as male-addressed issues that affect URM physician-scientists in particular. Key issues that threaten the retention of URM physician-scientists were identified through focused literature reviews; institutional environmental scans; and structured small- and large-group discussions with program directors, staff, and participants. These issues include bias and discrimination, personal wealth differential, the minority tax (i.e., service burdens placed on URM faculty who represent URM perspectives on committees and at conferences), lack of mentorship training, intersectionality and isolation, concerns about confirming stereotypes, and institutional-level factors. The authors present recommendations for how to create an environment in which URM physician-scientists can expect equitable opportunities to thrive, as institutions demonstrate proactive allyship and remove structural barriers to success. Recommendations include providing universal training to reduce interpersonal bias and discrimination, addressing the consequences of the personal wealth gap through financial counseling and benefits, measuring the service faculty members provide to the institution as advocates for URM faculty issues and compensating them appropriately, supporting URM faculty who wish to engage in national leadership programs, and sustaining institutional policies that address structural and interpersonal barriers to inclusive excellence.

PURPOSE To determine if interdisciplinary research has increased between 2005 and 2015, based on an analysis of journal articles containing at least 1 author from Johns Hopkins University, and to compare different methods for determining the disciplinarity of research articles. METHOD In 2017-2018, 100 peer-reviewed biomedical science articles were randomly selected from years 2005, 2010, and 2015 and classified as unidisciplinary or interdisciplinary based on Scopus author affiliation data (method 1). The corresponding authors of the 2010 and 2015 articles were sent a survey asking them to describe the disciplines involved in their research (method 2) and to define their research as unidisciplinary or interdisciplinary based on provided definitions (method 3). RESULTS There was a statistically significant increase in the proportion of interdisciplinary articles in 2015 compared with both 2005 and 2010 (P = .02). Comparison of the 3 methods indicated that 45% of the articles were classified as interdisciplinary based on author affiliation data (method 1), 40% based on the corresponding author's description of the disciplines involved in their research (method 2), and 71% based on the corresponding author's definition of their article's disciplinarity (method 3). There was a statistically significant difference in the proportion of articles classified as interdisciplinary between methods 1 and 3 (P < .001) and between methods 2 and 3 (P < .001). CONCLUSIONS This study found that interdisciplinary research increased at Johns Hopkins University over the past decade and highlights the difference between corresponding authors' views of their own research and other methods for determining interdisciplinarity.

BACKGROUNDThe efficacy of polyclonal high titer convalescent plasma to prevent serious complications of COVID-19 in outpatients with recent onset of illness is uncertain.METHODSThis multicenter, double-blind randomized controlled trial compared the efficacy and safety of SARS-CoV-2 high titer convalescent plasma to placebo control plasma in symptomatic adults ≥18 years positive for SARS-CoV-2 regardless of risk factors for disease progression or vaccine status. Participants with symptom onset within 8 days were enrolled, then transfused within the subsequent day. The measured primary outcome was COVID-19-related hospitalization within 28 days of plasma transfusion. The enrollment period was June 3, 2020 to October 1, 2021.RESULTSA total of 1225 participants were randomized and 1181 transfused. In the pre-specified modified intention-to-treat analysis that excluded those not transfused, the primary endpoint occurred in 37 of 589 (6.3%) who received placebo control plasma and in 17 of 592 (2.9%) participants who received convalescent plasma (relative risk, 0.46; one-sided 95% upper bound confidence interval 0.733; P=0.004) corresponding to a 54% risk reduction. Examination with a model adjusting for covariates related to the outcome did not change the conclusions.CONCLUSIONEarly administration of high titer SARS-CoV-2 convalescent plasma reduced outpatient hospitalizations by more than 50%. High titer convalescent plasma is an effective early outpatient COVID-19 treatment with the advantages of low cost, wide availability, and rapid resilience to variant emergence from viral genetic drift in the face of a changing pandemic.Trial RegistrationClinicalTrials.gov number, NCT04373460.

Background The National Patient‐Centered Clinical Research Network Blood Pressure Control Laboratory Surveillance System was established to identify opportunities for blood pressure (BP) control improvement and to provide a mechanism for tracking improvement longitudinally. Methods and Results We conducted a serial cross‐sectional study with queries against standardized electronic health record data in the National Patient‐Centered Clinical Research Network (PCORnet) common data model returned by 25 participating US health systems. Queries produced BP control metrics for adults with well‐documented hypertension and a recent encounter at the health system for a series of 1‐year measurement periods for each quarter of available data from January 2017 to March 2020. Aggregate weighted results are presented overall and by race and ethnicity. The most recent measurement period includes data from 1 737 995 patients, and 11 956 509 patient‐years were included in the trend analysis. Overall, 15% were Black, 52% women, and 28% had diabetes. BP control ( Conclusions Major opportunities exist for improving BP control and reducing disparities, especially through consistent medication intensification when BP is uncontrolled. These data demonstrate substantial room for improvement and opportunities to close health equity gaps.

Background: Insufficient support for balancing career and family responsibilities hinders retention of physician-scientists. Programs to improve retention of this important group of faculty are crucial. Understanding the experiences of program implementers is key to refining and improving program offerings. Methods: We conducted an interpretive, descriptive, and qualitative study as part of an ongoing evaluation of the Doris Duke Charitable Foundation's Fund to Retain Clinical Scientists (FRCS) awards. We conducted telephone interviews with 12 program directors representing all 10 US medical schools who received the Doris Duke funding in 2016. Results: Of the 12 participants, 10 were women (83.3%). Participating program directors perceived the FRCS award as capable of producing paradigmatic changes regarding how responsibilities at home and work in academic medicine are viewed and integrated by early-career faculty members. The main qualitative themes that captured directors' experiences implementing the program were as follows: (1) championing a new paradigm of support, (2) lessons learned while implementing the new paradigm, (3) results of the new paradigm, and (4) sustaining the paradigm. Conclusions: These findings may help to inform development of similar programs to retain and support the career progress of physician-scientists with extraprofessional caregiving responsibilities. The interviews illuminate ways in which the Doris Duke FRCS award has driven institutional culture change by normalizing discussion and prompted reassessment of extraprofessional challenges and how best to aid early-career faculty members in overcoming these challenges.

The COVID-19 pandemic has prompted an unprecedented global research effort to better understand this virus and to identify promising treatments. In this essay, the authors note that defining activities as public health surveillance has important implications, because such activities do not require further ethical oversight, informed consent, or protections for vulnerable persons or communities.

Background/aim:Cost-efficient methods are essential for successful participant recruitment in clinical trials. Patient portal messages are an emerging means of recruiting potentially eligible patients into trials. We assessed the response rate and complaint rate from direct-to-patient, targeted recruitment through patient portals of an electronic medical record for a clinical trial, and compared response rates by differences in message content.Methods:The Study to Understand Fall Reduction and Vitamin D in You (STURDY) trial is a National Institutes of Health–sponsored, community-based study of vitamin D supplementation for fall prevention in older adults conducted at Johns Hopkins. Potential participants were identified using the Epic electronic medical record at the Johns Hopkins Health System based on age (≥70 years), ZIP code (30-mile radius of study site), and prior activation of a patient portal account. We prepared a shorter message and a longer message. Both had basic information about study participation, but the longer message also contained information about the significance of the study and a personal invitation from the STURDY principal investigator. The Hopkins Institutional Review Board did not require prior consent from the patient or their providers. We calculated the response rate and tracked the number of complaints and requests for removal from future messages. We also determined response rate according to message content.Results:Of the 5.5 million individuals receiving care at the Johns Hopkins Health System, a sample of 6896 met our inclusion criteria and were sent one patient portal recruitment message between 6 April 2017 and 3 August 2017. Assessment of enrollment by this method ended on 1 December 2017. There were 116 patients who expressed interest in the study (response rate: 1.7%). Twelve (0.2%) recipients were randomized. There were two complaints (0.03%) and one request to unsubscribe from future recruitment messages (0.01%). Response rate was higher with the longer message than the shorter message (2.1% vs 1.2%; p = 0.005).Conclusion:Patient portal messages inviting seniors to participate in a randomized controlled trial resulted in a response rate similar to commercial email marketing and resulted in very few complaints or opt-out requests. Furthermore, a longer message with more content enhanced response rate. Recruitment through patient portals might be an effective strategy to enroll trial participants.

ObjectivesWomen report higher atrial fibrillation (AF) symptom severity and receive less AF therapies than their male counterparts. It is understudied if differences in AF therapies received explains sex differences in AF symptom severity. We investigate the impact of sex and AF therapies on patient-reported outcomes.MethodsParticipants were recruited (n=953) across four academic medical centres with an AF diagnosis and age ≥18 years. Patient-reported outcomes (AF symptom severity, AF-related quality of life, functional status and emotional status) were determined by biannual surveys. We performed multiple linear regressions on propensity-matched cohorts to determine the association of AF therapies and sex on patient-reported outcomes.ResultsOur study population (n=953) was 65% male (n=616), 93% white (n=890) and 72 (±10) years old. Individuals receiving rate control therapy reported comparatively lower AF-related quality of life (−7.22, 95% CI −11.51 to –2.92) and poorer functional status (−3.69, 95% CI −5.27 to –2.12). Individuals receiving rhythm control strategies did not report significantly different patient-reported outcomes. Women were more likely to report poorer functional status (−2.63, 95% CI −3.86 to –1.40) and poorer AF-related quality of life, higher anxiety (2.33, 95% CI 1.07 to 3.59), higher symptoms of depression (1.48, 95% CI 0.31 to 2.65) and AF symptom severity (0.29, 95% CI 0.07 to 0.52).ConclusionsFemale sex was associated with comparatively poorer AF symptom severity and quality of life, and this association remained after accounting for AF therapies received. Receiving rate control medication alone was associated with comparatively poorer AF-related quality of life and functional status.

Background In atrial fibrillation (AF), there are known sex and sociodemographic disparities in clinical outcomes such as stroke. We investigate whether disparities also exist with respect to patient-reported outcomes. We explored the association of sex, age, and education level with patient-reported outcomes (AF-related quality of life, symptom severity, and emotional and functional status). Methods The PaTH AF cohort study recruited participants (N = 953) with an AF diagnosis and age ≥ 18 years across 4 academic medical centers. We performed longitudinal multiple regression with random effects to determine if individual characteristics were associated with patient-reported outcomes. Results Women reported poorer functional status (β − 2.23, 95% CI: -3.52, − 0.94) and AF-related quality of life (β − 4.12, 95% CI: -8.10, − 0.14), and higher symptoms of anxiety (β 2.08, 95% CI: 0.76, 3.40), depression (β 1.44, 95% CI: 0.25, 2.63), and AF (β 0.29, 95% CI: 0.08, 0.50). Individuals

Introduction: The COVID-19 pandemic has required urgent scientific response to investigate the disease, its prevention and treatment and interactions with cardiovascular conditions. Consequently, a centralized workflow was needed to effectively recruit, screen and connect volunteers to COVID-19 research opportunities. Objective: To create a centralized registry to match eligible and interested volunteers ≥18 years with COVID-19 outpatient research studies at an academic health system. Methods: Key stakeholders, including researchers and participant advocates, collaborated to build the Hopkins Opportunity for Participant Engagement (HOPE) Registry in English and Spanish. REDCap, a secure web-based application, served as the Registry platform. Study teams recruiting for outpatient studies were invited to present their studies through the Registry. Study volunteers were recruited using multiple methods, including patient portal messages, email, social media, and online advertisement. The Registry included COVID testing results and participant survey of demographic and COVID-19 related questions. Branching logic was used to pre-screen and present participating studies for which the person was eligible. The individual then selected which studies, if any, they were interested in. Study teams received an automatic notification and reached out directly to individuals expressing interest in their study ( Figure ). Results: The HOPE Registry includes 7 studies and has enrolled 4186 people. Over half (55%) were >55 years and the majority were female (64%). Racial/ethnic groups represented were Whites (80%), Black s (9%), Asians (4.7%), Hispanics (5%), and American Indian (0.3%). Participants were interested in: 29%, treatment study; 37%, vaccine study; and 66%, donating plasma. Within 10 weeks, 585 persons were matched with an actively recruiting study. Conclusions: The ongoing HOPE registry has shown promise in engaging individuals with COVID-19 research and improving research recruitment workflow.

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 [IQR], 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.).

There is a need for multimodal strategies to keep research participants informed about study results. Our aim was to characterize preferences of genomic research participants from two institutions along four dimensions of general research result updates: content, timing, mechanism, and frequency. Methods: We conducted a web-based cross-sectional survey that was administered from 25 June 2018 to 5 December 2018. Results: 397 participants completed the survey, most of whom (96%) expressed a desire to receive research updates. Preferences with high endorsement included: update content (brief descriptions of major findings, descriptions of purpose and goals, and educational material), update timing (when the research is completed, when findings are reviewed, when findings are published, and when the study status changes), update mechanism (email with updates, and email newsletter), and update frequency (every three months). Hierarchical cluster analyses based on the four update preferences identified four profiles of participants with similar preference patterns. Very few participants in the largest profile were comfortable with budgeting less money for research activities so that researchers have money to set up services to send research result updates to study participants. Conclusion: Future studies may benefit from exploring preferences for research result updates, as we have in our study. In addition, this work provides evidence of a need for funders to incentivize researchers to communicate results to participants.

Background/Aims: Many investigators have tested interventions to improve research participant understanding of information shared during the informed consent process, using a variety of methods and with mixed results. A valid criticism of most consent research is that studies are often conducted in simulated research settings rather than ongoing clinical studies. The present study rigorously tested two simple and easily adoptable strategies for presenting key consent information to participants eligible to enroll in six actual clinical trials (i.e. six parent studies). Methods: In collaboration with the study team from each parent study, we developed two consent interventions: a fact sheet and an interview-style video. The content of each of the intervention was based on the information shared in the consent form approved for each parent study. Participants were randomized to the standard consent process, or to one of the two interventions. Once exposed to the assigned consent mode, participants were asked to complete an assessment of understanding. The study was powered to determine whether those exposed to the fact sheet or video performed better on the consent assessment compared to those exposed to the standard consent. We also assessed participant satisfaction with the consent process. Results: A total of 284 participants were randomized to one of the three consent arms. Assessments of understanding were completed with a total of 273 participants from July 2017 to April 2019. Participants exposed to the video had better understanding scores compared to those exposed to the standard consent form process ( p value = 0.020). Participants were more satisfied with the video when compared to the standard consent. Participants who received the fact sheet did not achieve higher overall understanding or satisfaction scores when compared to the standard consent process. Conclusion: This randomized study of two novel consent interventions across six different clinical trials demonstrated a statistically significant difference in participant understanding based on overall scores among those exposed to the video intervention compared to those exposed to the standard consent.

Background It is unclear whether chronic use of immunosuppressive drugs worsens or improves the severity of coronavirus disease 2019 (COVID-19), with plausible mechanisms for both. Methods Retrospective cohort study in 2121 consecutive adults with acute inpatient hospital admission between 4 March and 29 August 2020 with confirmed or suspected COVID-19 in a large academic health system, with adjustment for confounding with propensity score–derived stabilized inverse probability of treatment weights. Chronic immunosuppression was defined as prescriptions for immunosuppressive drugs current at the time of admission. Outcomes included mechanical ventilation, in-hospital mortality, and length of stay. Results There were 2121 patients admitted with laboratory-confirmed (1967, 93%) or suspected (154, 7%) COVID-19 during the study period, with a median age of 55 years (interquartile range, 40–67). Of these, 108 (5%) were classified as immunosuppressed before COVID-19, primarily with prednisone (>7.5 mg/day), tacrolimus, or mycophenolate mofetil. Among the entire cohort, 311 (15%) received mechanical ventilation; the median (interquartile range) length of stay was 5.2 (2.5–10.6) days, and 1927 (91%) survived to discharge. After adjustment, there were no significant differences in the risk of mechanical ventilation (hazard ratio [HR], .79; 95% confidence interval [CI], .46–1.35), in-hospital mortality (HR, .66; 95% CI, .28–1.55), or length of stay (HR, 1.16; 95% CI, .92–1.47) among individuals with immunosuppression and counterparts. Conclusions Chronic use of immunosuppressive drugs was neither associated with worse nor better clinical outcomes among adults hospitalized with COVID-19 in one US health system., Among adults with confirmed or suspected coronavirus disease 2019 (COVID-19), chronic use of immunosuppressive drugs was neither associated with worse nor better clinical outcomes such as mechanical ventilation, in-hospital mortality, or length of stay.

The COVID-19 pandemic changed the clinical research landscape in America. The most urgent challenge has been to rapidly review protocols submitted by investigators that were designed to learn more about or intervene in COVID-19. International Review Board (IRB) offices developed plans to rapidly review protocols related to the COVID-19 pandemic. An online survey was conducted with the IRB Directors at Clinical and Translational Science Awards (CTSA) institutions as well as two focus groups. Across the CTSA institutions, 66% reviewed COVID-19 protocols across all their IRB committees, 22% assigned protocols to just one committee, and 10% created a new committee for COVID-19 protocols. Fifty-two percent reported COVID-19 protocols were reviewed much faster, 41% somewhat faster, and 7% at the same speed as other protocols. Three percent reported that the COVID-19 protocols were reviewed with much better quality, 32% reported slightly better quality, and 65% reported the reviews were of the same quality as similar protocols before the COVID-19 pandemic. IRBs were able to respond to the emergent demand for reviewing COVID-19 protocols. Most of the increased review capacity was due to extra effort by IRB staff and members and not changes that will be easily implemented across all research going forward.

Background: The Coronavirus Disease 2019 (COVID-19) pandemic has had substantial global morbidity and mortality. Clinical research related to prevention, diagnosis, and treatment of COVID-19 is a top priority. Effective and efficient recruitment is challenging even without added constraints of a global pandemic. Recruitment registries offer a potential solution to slow or difficult recruitment. Objectives: The purpose of this paper is to describe the design and implementation of a digital research recruitment registry to optimize awareness and participant enrollment for COVID-19-related research in Baltimore and to report preliminary results. Methods: Planning began in March 2020, and the registry launched in July 2020. The primary recruitment mechanisms include electronic medical record data, postcards distributed at testing sites, and digital advertising campaigns. Following consent in a Research Electronic Data Capture survey, participants answer questions related to COVID-19 exposure, testing, and willingness to participate in research. Branching logic presents participants with studies they might be eligible for. Results: As of March 24, 2021, 9010 participants have enrolled, and 64.2% are female, 80.6% are White, 9.4% are Black or African American, and 6% are Hispanic or Latino. Phone outreach has had the highest response rate (13.1%), followed by email (11.9%), text (11.4%), and patient portal message (9.4%). Eleven study teams have utilized the registry, and 4596 matches have been made between study teams and interested volunteers. Conclusion: Effective and efficient recruitment strategies are more important now than ever due to the time-limited nature of COVID-19 research. Pilot efforts have been successful in connecting interested participants with recruiting study teams.

Background/aims:Electronic-based recruitment methods are increasingly utilized in clinical trials to recruit and enroll research participants. The cost-effectiveness of electronic-based methods and impact on sample generalizability is unknown. We compared recruitment yields, cost-effectiveness, and demographic characteristics across several electronic and traditional recruitment methods.Methods:We analyzed data from the diet gout trial recruitment campaign. The diet gout trial was a randomized, controlled, cross-over trial that examined the effects of a dietary approaches to stop hypertension (DASH)–like diet on uric acid levels in adults with gout. We used four electronic medical record and four non-electronic medical record–based recruitment methods to identify and recruit potentially eligible participants. We calculated the response rate, screening visit completion rate, and randomization rate for each method. We also determined cost per response, the screening, and randomization for each method. Finally, we compared the demographic characteristics among individuals who completed the screening visit by recruitment method.Results:Of the 294 adults who responded to the recruitment campaign, 51% were identified from electronic medical record–based methods. Patient portal messaging, an electronic medical record–based method, resulted in the highest response rate (4%), screening visit completion rate (37%), and randomization rate (21%) among these eight methods. Electronic medical record–based methods ($60) were more cost-effective per response than non-electronic medical record–based methods ($107). Electronic-based methods, including patient portal messaging and Facebook, had the highest proportion of White individuals screened (52% and 60%). Direct mail to non-active patient portal increased enrollment of traditionally under-represented groups, including both women and African Americans.Conclusion:An electronic medical record–based recruitment strategy that utilized the electronic medical record for participant identification and postal mailing for participant outreach was cost-effective and increased participation of under-represented groups. This hybrid strategy represents a promising approach to improve the timely execution and broad generalizability of future clinical trials.

IntroductionWe developed a service to identify potential study participants through electronic medical records and deliver study invitations through patient portals.MethodsThe service was piloted in a cohort study that used multiple recruitment methods.ResultsPatient portal messages were sent to 1303 individuals and the enrollment rate was 10% (n=127). The patient portal enrollment rate was significantly higher than email and post mail (4%) strategies.ConclusionPatient portal messaging was an effective recruitment strategy.

This study aimed to explore patient-, provider-, and system-level factors that may contribute to elevated risk of patient safety events among persons with serious mental illness (SMI). We conducted a medical record review of medical/surgical admissions in Maryland hospitals from 1994 to 2004 for a community-based sample of adults with SMI (N = 790 hospitalizations). We estimated the prevalence of multiple patient, provider, and system factors that could influence patient safety among persons with SMI. We conducted a case crossover analysis to examine the relationship between these factors and adverse patient safety events. Patients’ mental status, level of consciousness, disease severity, and providers’ lack of patient monitoring, delay/failure to seek consultation, lack of trainee supervision, and delays in care were positively associated with adverse patient safety events (p < 0.05). Efforts to reduce SMI-related patient safety risks will need to be multifaceted and address both patient- and provider-level factors.

Author(s): Fukushima, Masanori; Austin, Christopher; Sato, Norihiro; Maruyama, Tatsuya; Navarro, Eileen; Rocca, Mitra; Demotes, Jacques; Haendel, Melissa; Volchenboum, Samuel L; Cowperthwaite, Matthew; Silverstein, Jonathan C; Webb, Chris; Sim, Ida; Chase, Marianne; Speakman, John; Augustine, Erika; Ford, Daniel E; Kush, Rebecca | Abstract: Introduction:Global data sharing is essential. This is the premise of the Academic Research Organization (ARO) Council, which was initiated in Japan in 2013 and has since been expanding throughout Asia and into Europe and the United States. The volume of data is growing exponentially, providing not only challenges but also the clear opportunity to understand and treat diseases in ways not previously considered. Harnessing the knowledge within the data in a successful way can provide researchers and clinicians with new ideas for therapies while avoiding repeats of failed experiments. This knowledge transfer from research into clinical care is at the heart of a learning health system. Methods:The ARO Council wishes to form a worldwide complementary system for the benefit of all patients and investigators, catalyzing more efficient and innovative medical research processes. Thus, they have organized Global ARO Network Workshops to bring interested parties together, focusing on the aspects necessary to make such a global effort successful. One such workshop was held in Austin, Texas, in November 2017. Representatives from Japan, Taiwan, Singapore, Europe, and the United States reported on their efforts to encourage data sharing and to use research to inform care through learning health systems. Results:This experience report summarizes presentations and discussions at the Global ARO Network Workshop held in November 2017 in Austin, TX, with representatives from Japan, Korea, Singapore, Taiwan, Europe, and the United States. Themes and recommendations to progress their efforts are explored. Standardization and harmonization are at the heart of these discussions to enable data sharing. In addition, the transformation of clinical research processes through disruptive innovation, while ensuring integrity and ethics, will be key to achieving the ARO Council goal to overcome diseases such that people not only live longer but also are healthier and happier as they age. Conclusions:The achievement of global learning health systems will require further exploration, consensus-building, funding aligned with incentives for data sharing, standardization, harmonization, and actions that support global interests for the benefit of patients.