scholarly journals Plutonium in Manhattan Project workers: Using autopsy data to evaluate organ content and dose estimates based on urine bioassay with implications for radiation epidemiology

PLoS ONE ◽  
2021 ◽  
Vol 16 (10) ◽  
pp. e0259057
Author(s):  
Martin Šefl ◽  
Joey Y. Zhou ◽  
Maia Avtandilashvili ◽  
Stacey L. McComish ◽  
Sergei Y. Tolmachev
Keyword(s):  
Manhattan Project ◽  
The United States ◽  
Radiochemical Analysis ◽  
Post Mortem ◽  
Post Exposure ◽  
Commitment Period ◽  
Red Marrow ◽  
Effective Doses ◽  
Radiation Epidemiology

Purpose Radiation dose estimates in epidemiology typically rely on intake predictions based on urine bioassay measurements. The purpose of this article is to compare the conventional dosimetric estimates for radiation epidemiology with the estimates based on additional post-mortem tissue radiochemical analysis results. Methods The comparison was performed on a unique group of 11 former Manhattan Project nuclear workers, who worked with plutonium in the 1940s, and voluntarily donated their bodies to the United States Transuranium and Uranium Registries. Results Post-mortem organ activities were predicted using different sets of urine data and compared to measured activities. Use of urinalysis data collected during the exposure periods overestimated the systemic (liver+skeleton) deposition of 239Pu by 155±134%, while the average bias from using post-exposure urinalyses was –4±50%. Committed effective doses estimated using early urine data differed from the best estimate by, on average, 196±193%; inclusion of follow-up urine measurements in analyses decreased the mean bias to 0.6±36.3%. Cumulative absorbed doses for the liver, red marrow, bone surface, and brain were calculated for the actual commitment period. Conclusion On average, post-exposure urine bioassay results were in good agreement with post-mortem tissue analyses and were more reliable than results of urine bioassays collected during the exposure.

scholarly journals Relocation of a GPS collared conflict Sloth Bear Melursus ursinus (Mammalia: Carnivora) in Karnataka, India

2021 ◽  
Vol 13 (3) ◽  
pp. 17856-17864
Author(s):  
Attur Shanmugam Arun ◽  
Swaminathan Shanmugavelu ◽  
Yogaraj Pannerselvam ◽  
Thomas Robert Sharp ◽  
Sydney Stephens ◽  
...  
Keyword(s):  
United States ◽  
National Park ◽  
Movement Pattern ◽  
The United States ◽  
Early Morning ◽  
Post Mortem ◽  
Explosive Device ◽  
Sloth Bear ◽  
Melursus Ursinus

The relocation of conflict bears has been a tool used widely across the United States and Canada with mixed results.  It has also been used in India with Sloth Bears, though without follow-up it remains unknown how successful these relocation efforts have been.  We documented the capture and relocation of a conflict female Sloth Bear from a rural area near Bangalore, Karnataka, India to Bannerghatta National Park roughly 30km away.  This female bear, approximately six years old, was fitted with a VHF/GPS store-on-board collar, and her movements tracked.  She did not attempt to return to her capture location but during the first two-month period after being released she did roam over an area roughly six times that of typical female Sloth Bear home range.  Over the subsequent months the area over which she roamed continued to decline.  She was least active mid-day and more active in the evening, night, and early morning.  During her last few weeks in January, before she was killed by an explosive device just outside of the park, her movement pattern shrank considerably.  The post-mortem examination showed that she had been pregnant when killed and would have given birth within the next two weeks.  These reduced movements were consistent with those of periparturient female bears or potentially with a bear becoming more acclimated to her new surroundings.  The relocation effort appeared successful up until the Sloth Bear was killed by poacher activity. 

scholarly journals Post-exposure Prophylaxis or Preemptive Therapy for SARS-Coronavirus-2: Study Protocol for a Pragmatic Randomized Controlled Trial

2020 ◽  
Author(s):  
Sylvain A Lother ◽  
Mahsa Abassi ◽  
Alyssa Agostinis ◽  
Ananta S Bangdiwala ◽  
Matthew P Cheng ◽  
...  
Keyword(s):  
Intensive Care ◽  
Disease Severity ◽  
The United States ◽  
Ordinal Scale ◽  
Post Exposure Prophylaxis ◽  
Symptom Duration ◽  
Post Exposure ◽  
Trial Outcome ◽  
Exposure Prophylaxis

AbstractBackgroundThe severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in December 2019 causing the coronavirus disease 2019 (COVID-19) pandemic. Currently, there are a lack of evidence-based therapies to prevent COVID-19 following exposure, or to prevent worsening of symptoms following confirmed infection. We describe the design of a clinical trial of hydroxychloroquine for post-exposure prophylaxis and pre-emptive therapy for COVID-19.MethodsWe will conduct two nested multicenter international double-blind randomized placebo-controlled clinical trials of hydroxychloroquine for: 1) post-exposure prophylaxis (PEP) of asymptomatic household contacts or healthcare workers exposed to COVID-19 within the past four days, and 2) pre-emptive therapy (PET) for symptomatic outpatients with COVID-19 with a total symptom duration of less than 4 days. We will recruit 1500 patients for each the PEP and PET trials. Participants will be randomized 1:1 to receive 5 days of hydroxychloroquine or placebo. The primary PEP trial outcome will be the incidence of symptomatic COVID-19 disease. The primary PET trial outcome will be an ordinal scale of disease severity (not hospitalized; hospitalized without intensive care, hospitalization with intensive care, or death). Participant screening, informed consent, and follow up will be exclusively internet-based with appropriate regulatory and research ethics board approvals in Canada and the United States.DiscussionThese complementary randomized control trials are innovatively designed and adequately powered to rapidly answer urgent questions regarding the effectiveness of hydroxychloroquine to reduce transmission and disease severity of COVID-19 during a pandemic. In-person participant follow-up will not be conducted in order to facilitate social distancing strategies and reduce risks of exposure to study personnel. Innovative trial approaches are needed to urgently assess therapeutic options to mitigate the global impact of this pandemic.Trials Registrationclinicaltrials.gov (NCT04308668); 16 March 2020.

scholarly journals 987. Improving Patient Access to HIV Post-Exposure Prophylaxis with Pharmacist Involvement

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S522-S522
Author(s):  
Katlyn H Grossman
Keyword(s):  
Hospital Pharmacy ◽  
Medical Center ◽  
Cost Savings ◽  
The United States ◽  
Post Exposure Prophylaxis ◽  
Total Cost ◽  
Post Exposure ◽  
Exposure Prophylaxis ◽  
The Impact

Abstract Background Appropriate use of post-exposure prophylaxis (PEP) after isolated sexual, injection drug use, or other exposures to HIV is an effective tool to reduce the risk of HIV acquisition. PEP completion rates are low, with literature reporting only 40% of sexual assaulted persons adhering to a full 28-day course. One important barrier to adherence can be access to medications in a timely manner. In the United States, a four week course of PEP costs nearly $4,000 without insurance and can remain unaffordable with high copays and deductibles for patients who are underinsured. Methods A pharmacist in the Infectious Disease (ID) clinic was notified of all non-occupational post-exposure prophylaxis (nPEP) cases referred from the Emergency Department for follow up and coordinated benefits investigation, ensured low or no cost medication access, completed medication reconciliation, counseled on PEP adherence, and coordinated filling of same day prescriptions at the hospital based pharmacy. To assess the impact of pharmacist involvement, a retrospective review of nPEP cases over a 6 month period were compared to a 6 month period prior to pharmacist presence in clinic. Results 16 nPEP cases were seen by a pharmacist compared to 8 nPEP cases seen in the ID clinic without pharmacist involvement. 100% of patients received medications prior to leaving the medical center, compared to 63% of cases filling at the hospital pharmacy prior to pharmacist presence. 25% of patients required an insurance related override in order to access PEP urgently. The average out of pocket cost was $2.25 with maximum total cost being $7.30. Prior to pharmacist involvement, the average out of pocket cost was $475 for complete PEP regimen with a maximum total cost of $3,733.40. 42% of patients completed their entire PEP course and came to follow up appointment after pharmacist involvement, compared to 31% of patients prior to pharmacist presence. Conclusion Pharmacist involvement led to a substantial cost savings to patients receiving nPEP. It was also associated with higher capture rates of prescriptions filled at the hospital pharmacy along with a higher rate of PEP completion and follow up. Disclosures All Authors: No reported disclosures

scholarly journals Natural History and Evolution of Anti-Interferon-γ Autoantibody-Associated Immunodeficiency Syndrome in Thailand and the United States

2019 ◽  
Vol 71 (1) ◽  
pp. 53-62 ◽  
Author(s):  
Gloria H Hong ◽  
Ana M Ortega-Villa ◽  
Sally Hunsberger ◽  
Ploenchan Chetchotisakd ◽  
Siriluck Anunnatsiri ◽  
...  
Keyword(s):  
United States ◽  
Natural History ◽  
The United States ◽  
Interferon Γ ◽  
Mycobacterium Abscessus ◽  
Annual Data ◽  
Persistent Infections ◽  
Ifn Γ ◽  
Immunodeficiency Syndrome

Abstract Background The natural history of anti-interferon-γ (IFN-γ) autoantibody-associated immunodeficiency syndrome is not well understood. Methods Data of 74 patients with anti-IFN-γ autoantibodies at Srinagarind Hospital, Thailand, were collected annually (median follow-up duration, 7.5 years). Annual data for 19 patients and initial data for 4 patients with anti-IFN-γ autoantibodies at the US National Institutes of Health were collected (median follow-up duration, 4.5 years). Anti-IFN-γ autoantibody levels were measured in plasma samples. Results Ninety-one percent of US patients were of Southeast Asian descent; there was a stronger female predominance (91%) in US than Thai (64%) patients. Mycobacterium abscessus (34%) and Mycobacterium avium complex (83%) were the most common nontuberculous mycobacteria in Thailand and the United States, respectively. Skin infections were more common in Thailand (P = .001), whereas bone (P < .0001), lung (P = .002), and central nervous system (P = .03) infections were more common in the United States. Twenty-four percent of Thai patients died, most from infections. None of the 19 US patients with follow-up data died. Anti-IFN-γ autoantibody levels decreased over time in Thailand (P < .001) and the United States (P = .017), with either cyclophosphamide (P = .01) or rituximab therapy (P = .001). Conclusions Patients with anti-IFN-γ autoantibodies in Thailand and the United States had distinct demographic and clinical features. While titers generally decreased with time, anti-IFN-γ autoantibody disease had a chronic clinical course with persistent infections and death. Close long-term surveillance for new infections is recommended.

scholarly journals How Family Physicians Practice the Principle of Remission Along the Glycemic Continuum

2020 ◽  
Vol 11 ◽  
pp. 215013272097774
Author(s):  
Stephanie T. Fulleborn ◽  
Paul F. Crawford ◽  
Jeremy T. Jackson ◽  
Christy J.W. Ledford
Keyword(s):  
Type 2 Diabetes ◽  
Medical Record ◽  
The United States ◽  
Case Scenario ◽  
Cross Sectional ◽  
Normal Glucose ◽  
Normal Glucose Regulation

Introduction Recent evidence reveals that diabetes and prediabetes (preDM) can be reversed to normal glucose regulation (NGR) through significant weight loss, but how physicians clinically identify the principles of partial and complete remission of diabetes is largely unknown. Methods As part of the cross-sectional omnibus survey conducted in March 2019 at a professional annual meeting in the United States, physician participants answered case scenario questions about the diagnosis and documentation of patients with preDM and type 2 diabetes (T2DM). Results Of the registered conference attendees, 387 (72.7%) responded. When presented with the initial case of preDM, 201 physicians (70.8%) selected R73.03 Prediabetes. In a follow-up encounter with improved lab results, 118 physicians (58.7%) indicated that they would not chart any diabetes-related code and 62 (30.8%) would chart preDM again. When presented with the case of T2DM, 256 physicians (90.1%) indicated E11.0–E11.9 Type 2 Diabetes. In the follow-up encounter, only 38 (14.8%) coded a diagnosis reflecting remission from T2DM to prediabetes and 211 (82.4%) charted T2DM. Conclusion Physicians may be reluctant to document diabetes regression as there is little evidence for long-term outcomes and “downgrading” the diagnosis in the medical record may cause screenings to be missed. Documenting this regression in the medical record should communicate the accurate point on the continuum of glucose intolerance with both the patient and the care team.

scholarly journals Testing telediagnostic thyroid ultrasound in Peru: a new horizon in expanding access to imaging in rural and underserved areas

2021 ◽  
Author(s):  
T. J. Marini ◽  
S. L. Weiss ◽  
A. Gupta ◽  
Y. T. Zhao ◽  
T. M. Baran ◽  
...  
Keyword(s):  
Thyroid Nodule ◽  
Standard Of Care ◽  
The United States ◽  
Epidemiological Studies ◽  
Thyroid Ultrasound ◽  
Target Region ◽  
Experienced Radiologist ◽  
Significant Difference ◽  
Size Evaluation

Abstract Purpose Thyroid ultrasound is a key tool in the evaluation of the thyroid, but billions of people around the world lack access to ultrasound imaging. In this study, we tested an asynchronous telediagnostic ultrasound system operated by individuals without prior ultrasound training which may be used to effectively evaluate the thyroid and improve access to imaging worldwide. Methods The telediagnostic system in this study utilizes volume sweep imaging (VSI), an imaging technique in which the operator scans the target region with simple sweeps of the ultrasound probe based on external body landmarks. Sweeps are recorded and saved as video clips for later interpretation by an expert. Two operators without prior ultrasound experience underwent 8 h of training on the thyroid VSI protocol and the operation of the telemedicine platform. After training, the operators scanned patients at a health center in Lima. Telediagnostic examinations were sent to the United States for remote interpretation. Standard of care thyroid ultrasound was performed by an experienced radiologist at the time of VSI examination to serve as a reference standard. Results Novice operators scanned 121 subjects with the thyroid VSI protocol. Of these exams, 88% were rated of excellent image quality showing complete or near complete thyroid visualization. There was 98.3% agreement on thyroid nodule presence between VSI teleultrasound and standard of care ultrasound (Cohen’s kappa 0.91, P < 0.0001). VSI measured the thyroid size, on average, within 5 mm compared to standard of care. Readers of VSI were also able to effectively characterize thyroid nodules, and there was no significant difference in measurement of thyroid nodule size (P = 0.74) between VSI and standard of care. Conclusion Thyroid VSI telediagnostic ultrasound demonstrated both excellent visualization of the thyroid gland and agreement with standard of care thyroid ultrasound for nodules and thyroid size evaluation. This system could be deployed for evaluation of palpable thyroid abnormalities, nodule follow-up, and epidemiological studies to promote global health and improve the availability of diagnostic imaging in underserved communities.

scholarly journals SAT0172 UTILIZATION OF HYDROXYCHLOROQUINE AND CORTICOSTEROIDS AMONG LUPUS PATIENTS WITH INCIDENT END-STAGE RENAL DISEASE (ESRD) ONSET: A LONGITUDINAL STUDY USING USRDS REGISTRY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1027.2-1027
Author(s):  
A. R. Broder ◽  
W. Mowrey ◽  
A. Valle ◽  
B. Goilav ◽  
K. Yoshida ◽  
...  
Keyword(s):  
United States ◽  
Lupus Nephritis ◽  
Renal Disease ◽  
International Classification Of Diseases ◽  
The United States ◽  
Diagnostic Code ◽  
Prescribing Practices ◽  
Part D ◽  
Stage Renal Disease

Background:The development of ESRD due to lupus nephritis is one of the most common and serious complications of SLE. Mortality among SLE ESRD patients is 4-fold higher compared to lupus nephritis patients with preserved renal function1Mortality in SLE ESRD is also twice as high compared with non-SLE ESRD, even though SLE patients develop ESRD at a significantly younger age. In the absence of ESRD specific guidelines, medication utilization in SLE ESRD is unknown.Objectives:The objective of this study was to investigate the real-world current US-wide patterns of medication prescribing among lupus nephritis patients with new onset ESRD enrolled in the United States Renal Disease Systems (USRDS) registry. We specifically focused on HCQ and corticosteroids (CS) as the most used medications to treat SLE.Methods:Inclusion: USRDS patients 18 years and above with SLE as a primary cause of ESRD (International Classification of Diseases, 9thRevision (ICD9) diagnostic code 710.0, previously validated2). who developed ESRD between January 1st, 2006 and July 31, 2011 (to ensure at least 6 months of follow-up in the USRDS). Patients had to be enrolled in Medicare Part D (to capture pharmacy claims). The last follow-up date was defined as either the last date of continuous part D coverage or the end of the study period, Dec 31, 2013.Results:Of the 2579 patients included, 1708 (66%) were HCQ- at baseline, and 871 (34%) were HCQ+ at baseline. HCQ+ patients at baseline had a slightly lower duration of follow-up compared to HCQ- patients at baseline, median (IQR) of 2.32 (1.33, 3.97) years and 2.55 (1.44, 4.25) years, respectively, p= 0.02. During follow-up period, only 778 (30%) continued HCQ either intermittently or continuously to the last follow-up date, 1306 (51%) were never prescribed HCQ after baseline, and 495 (19%) discontinued HCQ before the last follow-up date. Of the 1801 patients who were either never prescribed or discontinued HCQ early after ESRD onset, 713 (40%) were prescribed CS to the end of the follow-up period: 55% were receiving a low dose <10mg/daily, and 43 were receiving moderate dose (10-20mg daily)Conclusion:HCQ may be underprescribed and CS may be overprescribed in SLE ESRD. Changing the current prescribing practices may improve outcomes in SLE ESRDReferences:[1]Yap DY et al., NDT 2012.[2]Broder A et al., AC&R 2016.Acknowledgments :The data reported here have been supplied by the United States Renal Data System (USRDS). The interpretation and reporting of these data are the responsibility of the author(s) and in no way should be seen as an official policy or interpretation of the U.S. government.Funding: :NIH/NIAMS K23 AR068441 (A Broder), NIH/NIAMS R01 AR 057327 and K24 AR 066109 (KH Costenbader)Disclosure of Interests: :Anna R. Broder: None declared, Wenzhu Mowrey: None declared, Anna Valle: None declared, Beatrice Goilav: None declared, Kazuki Yoshida: None declared, Karen Costenbader Grant/research support from: Merck, Consultant of: Astra-Zeneca

scholarly journals 986. Improvement in Administration of HIV Post-Exposure Prophylaxis in the Emergency Department Following Sexual Assault

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S521-S522
Author(s):  
Jennifer R Silva-Nash ◽  
Stacie Bordelon ◽  
Ryan K Dare ◽  
Sherrie Searcy
Keyword(s):  
Emergency Department ◽  
Sexual Assault ◽  
Hiv Transmission ◽  
Post Exposure Prophylaxis ◽  
Intervention Period ◽  
Post Intervention ◽  
Post Exposure ◽  
Assault Victims ◽  
Exposure Prophylaxis

Abstract Background Nonoccupational post exposure prophylaxis (nPEP) following sexual assault can prevent HIV transmission. A standardized Emergency Department (ED) protocol for evaluation, treatment, and follow up for post assault victims was implemented to improve compliance with CDC nPEP guidelines. Methods A single-center observational study of post sexual assault patients before/after implementation of an ED nPEP protocol was conducted by comparing the appropriateness of prescriptions, labs, and necessary follow up. A standardized order-set based on CDC nPEP guidelines, with involvement of an HIV pharmacist and ID clinic, was implemented during the 2018-2019 academic year. Clinical data from pre-intervention period (07/2016-06/2017) was compared to post-intervention period (07/2018-08/2019) following a 1-year washout period. Results During the study, 147 post-sexual assault patients (59 Pre, 88 Post) were included. One hundred thirty-three (90.4%) were female, 68 (46.6%) were African American and 133 (90.4%) were candidates for nPEP. Median time to presentation following assault was 12.6 hours. nPEP was offered to 40 (67.8%) and 84 (95.5%) patients (P&lt; 0.001) and ultimately prescribed to 29 (49.2%) and 71 (80.7%) patients (P&lt; 0.001) in pre and post periods respectively. Renal function (37.3% vs 88.6%; P&lt; 0.001), pregnancy (39.0% vs 79.6%; P&lt; 0.001), syphilis (3.4% vs 89.8%; P&lt; 0.001), hepatitis B (15.3% vs 95.5%; P&lt; 0.001) and hepatitis C (27.1% vs 94.3%) screening occurred more frequently during the post period. Labratory, nPEP Prescription and Follow up Details for Patients Prescribed nPEP Conclusion The standardization of an nPEP ED protocol for sexual assault victims resulted in increased nPEP administration, appropriateness of prescription, screening for other sexually transmitted infectious and scheduling follow up care. While guideline compliance dramatically improved, further interventions are likely warranted in this vulnerable population. Disclosures Ryan K. Dare, MD, MS, Accelerate Diagnostics, Inc (Research Grant or Support)

scholarly journals Response to treatment with intra-articular triamcinolone hexacetonide and triamcinolone acetonide in oligo articular juvenile idiopathic arthritis

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Rana Harhay ◽  
Wajiha Jeelani ◽  
Barbine Tchamba Agbor Agbor ◽  
Teresa Hennon ◽  
Brian H. Wrotniak ◽  
...  
Keyword(s):  
Juvenile Idiopathic Arthritis ◽  
Side Effects ◽  
Triamcinolone Acetonide ◽  
The United States ◽  
Response To Treatment ◽  
Joint Injection ◽  
Triamcinolone Hexacetonide ◽  
Active Arthritis ◽  
General Response

Abstract Background Oligo-articular juvenile idiopathic arthritis (Oligo JIA) is the most common subtype of juvenile idiopathic arthritis. Intra-articular corticosteroid (IAC) injection is a mainstay treatment of oligo JIA providing pain relief, improving mobility and preventing further joint destruction in the majority of patients. In 2015, production of triamcinolone hexacetonide (TH) an intra-articular corticosteroid was discontinued in the United States leading to use of triamcinolone acetonide (TA) as an alternative. In this study, we compared response to treatment in children with oligo JIA who underwent therapy with intra-articular TA and TH injection. Methods Our study is a retrospective chart review of children with oligo JIA who were treated with IAC injections with TH between January 2012 and June 2015 and TA between J uly 2015 and December 2018. The two groups were followed at John R. Oishei Children’s Hospital of Buffalo and were evaluated for response to treatment, side effects and predictors of response including duration of disease before treatment, erythrocyte sedimentation rate (ESR), and c-reactive protein (CRP). Response to treatment was defined as at least 6 months follow up without evidence of active arthritis in injected joints. Patients were considered to be non-responders if they continued to show active arthritis during their first follow up after joint injection. The primary objective was to evaluate whether there was a significant difference in rate of response between TH and TA. Results Forty-nine patients, 38 female and 11 male with oligo JIA were included in the study. The average age was 6.7 years. A total of 111 joints were injected includin g 78 knees, 13 ankles, 9 wrists, 4 hips, 4 elbows, 2 TMJ and one subtalar joint. In the TA group, 49% (29/59) did not show response to injection compared to 27% (14/52) in the TH group. After 6 months, response rates were better for individuals injected with TH compared to TA (73% vs. 51%). In general, response to intra-articular TH was superior to TA with P = .016 using chi-square test of independence. This difference in outcome was not influenced by other variables such as duration of illness before treatment (P value 0.784) or elevated ESR and CRP. No difference in side effects between the two groups were noted. Conclusion Our results in conjunction with prior published data suggests that TH intra-articular joint injection in oligo JIA is superior to TA, although future controlled trials are necessary for confirmation. An effective, long lasting treatment can have a great impact on the outcome of these children.

Transitioning a randomized controlled trial to a digital registry – experience from the TAILOR-PCI digital follow-up study on onboarding, engagement and geofencing consent rate

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
R Avram ◽  
D So ◽  
E Iturriaga ◽  
J Byrne ◽  
R.J Lennon ◽  
...  
Keyword(s):  
Clinical Trial ◽  
The United States ◽  
Mobile App ◽  
Funding Source ◽  
Location Tracking ◽  
Main Trial ◽  
Phone Calls ◽  
Effective Manner ◽  
Research Platform

Abstract Background/Introduction TAILOR-PCI is the largest cardiovascular genotype-based randomized trial (NCT#01742117) investigating whether genotype-guided selection of oral P2Y12 inhibitor therapy improves ischemic outcomes after percutaneous coronary intervention (PCI). The TAILOR-PCI Digital Sub-Study tests the feasibility of extending original follow-up of 1 year to 2 years using state-of-the-art digital solutions. Deep phenotyping acquired during a clinical trial can be leveraged by extending follow-up in an efficient and cost-effective manner using digital technology. Purpose Our objective is to describe onboarding and engagement of participants initially recruited in a large, pragmatic, international, multi-center clinical trial to a digital registry. Methods TAILOR-PCI participants, within 23 months of their index PCI, were invited by letters containing a URL to the Digital Sub-Study website (http://tailorpci.eurekaplatform.org). These invitations were followed by phone calls, if no response to the letter, to determine reason for non-participation. A NIH-funded direct-to-participant digital research platform (the Eureka Research Platform) was used to onboard, consent and enroll participants for the digital follow-up. Participants were asked to answer health-related surveys at fixed intervals using the Eureka mobile app and desktop platform. To capture hospitalizations, participants could enable geofencing to allow background location tracking, which triggered surveys if a hospitalization was detected. Result(s) Letters were mailed to 893 of 929 eligible participants across 22 sites in the United States and Canada leading to 226 homepage visits and 118 registrations. There were 107 consents (12.0% of invited; mean age: 66.4±9.0; 19 females [18%]): 47 (44%) participants consented after the letter, 36 (34%) consented after the 1st call and 24 (22%) consented after a 2nd call. Among those who consented, 100 were eligible (7 did not have a smartphone) 81 downloaded the study mobile app and 73 agreed for geofencing (Figure 1). Among the 722 invited participants who were surveyed, 354 declined participation: due to lack of time (146; 20.2%), lack of smartphone (125; 17.3%), difficulty understanding (41; 5.7%), concern about using smartphone (34; 4.7%), concern of data privacy (14; 1.9%), concerns of location tracking (6; 0.8%) and other reasons (57; 7.9%). Conclusion Extended follow-up of a clinical trial using a digital platform is feasible but uptake in this study population was limited largely due to lack of time or a smartphone among participants. Based on data from other digital studies, uptake may also have been limited since digital follow-up consent was not incorporated at the time of consent for the main trial. Figure 1. Onboarding of the digital substudy Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): National Institute of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

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