Impact of the removal of chocolate milk from school milk programs for children in Saskatoon, Canada

Studies in the United States report inclusion of flavoured milk in the diets of children and youth improves nutrient intakes. No research has investigated the contribution of flavoured milk to overall milk intake or the milk preferences of Canadian children. The objective of the study was to measure milk consumption (plain milk and flavoured milk) by children in an elementary school environment and investigate factors contributing to milk choice. A mixed-method research design was applied across 6 schools for 12 weeks. Milk waste was measured in grades 1–8 for 12 weeks. Weeks 1–4 (phase 1) and 9–12 (phase 3) provided both plain milk and flavoured milk as chocolate milk while weeks 5–8 (phase 2) provided plain milk only. Beverage Frequency Questionnaires were used in each phase (in grades 5–8 only) to assess usual beverage consumption. Statistical nutrient modelling was conducted to determine the effects of removing chocolate milk during phase 2 as a milk choice. Later, focus groups were conducted with students in grades 5–8 to determine what influences them to choose/not choose to drink milk. Total milk intake decreased by 12.3% when chocolate milk was removed from the schools (26.6% ± 5.2% to 14.31% ± 1.6%, p < 0.001). Milk choice was influenced by environmental factors as well as taste, cost, convenience, and variety. Total milk intake was associated with location (p = 0.035) and cost (p < 0.001), with rural students and/or those students receiving free milk drinking the greatest amount of milk. Nutrient modelling revealed chocolate milk is more cost-efficient and convenient at providing nutrients than alternative food/drink combinations.

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Disparity in Clinical Trial Opportunities for Patients with B-Cell Malignancies in the United States

Blood ◽

10.1182/blood-2018-99-117155 ◽

2018 ◽

Vol 132 (Supplement 1) ◽

pp. 4861-4861

Author(s):

Sikander Ailawadhi ◽

Sri Lekha Bodepudi ◽

Zan Tahir Shareef ◽

Fabiola Coromoto Cardozo ◽

Salman Ahmed ◽

...

Keyword(s):

United States ◽

Clinical Trial ◽

Clinical Trials ◽

Geographical Distribution ◽

Research Funding ◽

Phase 1 ◽

The United States ◽

Phase 2 ◽

B Cell Malignancies ◽

The Us

Abstract Background: Clinical trials are fundamental to advance therapeutics systematically and improve patient outcomes. Despite this, enrollment on clinical trials remains dismal in the United States (US) and is a constant focus of healthcare policy. We studied distribution of clinical trials for B-cell malignancies over time across the US and unique clinical trial opportunities i.e. individual clinical trials for the given diagnosis at a site that patients may have access to participate. Methods: We abstracted data from clinicaltrials.gov for all trials that had non-Hodgkin lymphoma (NHL) or multiple myeloma (MM) as an inclusion indication between 1999-2018. Clinical trial characteristics and distribution over US geographical divisions (West, Midwest, Northeast, and South) were studied, and differences were assessed by Chi-square test. Results: A total of 1930 trials were identified (NHL: 982, MM: 948), of which 483 were recruiting at the time of data abstraction (NHL: 250, MM: 233). Over the past 2 decades, 182691 patients were enrolled on the various trials (NHL: 81592, MM: 101099). Trials by phase of study included phase 1: 629, phase 1/2: 316, phase 2: 813, phase 2/3: 11 and phase 3: 161. Number of trials by phase separated by NHL and MM are shown in Figure 1. Of these, 197 trials were randomized (NHL: 67, MM: 130). Geographical distribution of trials by diagnosis type is shown in Figure 2. A total of 31806 unique trial opportunities were noted for MM and NHL, of which 9,513 were international and 22,293 were in the US, with a geographical distribution of 5080 in West, 8198 in Midwest, 3944 in Northeast, and 5071 in South. 4,883 of the unique trial opportunities were available at NCI/NCCN accredited sites and 17,410 were at non-NCI/NCCN sites in the US. Treatment characteristics of the trials included monoclonal antibodies in 1218, other targeted agents in 2641, stem cell transplant in 526, and other agents in 517 trials with several trials utilizing more than one of these therapeutic options. There was no statistically significant difference in the distribution of clinical trials by phase of study across various US geographical regions for MM (p=0.71), NHL (p=0.98) or combined MM+NHL (p=0.16). On the other hand, unique trial opportunities were significantly different by study phase and geographical distribution for MM, NHL or MM+NHL (all p<0.001) (Figure 3). Conclusions: Widespread access to clinical trials within a cancer diagnosis is imperative for generalizability of trial results. In a comprehensive, national analysis we noted that while it may appear that clinical trials are available across the US, sites where they are open are distributed unevenly, giving rise to a disparity in access to evidence-based therapeutic advancements for patients. Disclosures Ailawadhi: Janssen: Consultancy; Amgen: Consultancy; Pharmacyclics: Research Funding; Takeda: Consultancy; Celgene: Consultancy. Sher:Affimed: Research Funding.

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The COVID-19 pandemic continues to change the way people recreate outdoors: A second preliminary report on a national survey of outdoor enthusiasts amid the COVID-19 pandemic

10.31235/osf.io/dghba ◽

2020 ◽

Author(s):

William L. Rice ◽

Tim Mateer ◽

B. Derrick Taff ◽

Ben Lawhon ◽

Nathan Reigner ◽

...

Keyword(s):

Preliminary Report ◽

Research Effort ◽

Phase 1 ◽

Rapid Assessment ◽

Public Lands ◽

The United States ◽

Second Phase ◽

Phase 2 ◽

Leave No Trace ◽

The Way

The COVID-19 pandemic continues to alter daily life and lead to changes in the way we spend time outside. In an effort to gather timely and relevant data on national recreation patterns before, during, and after the pandemic, the Leave No Trace Center for Outdoor Ethics and its academic partner, Pennsylvania State University, have been working to conduct a study that can offer guidance to land managers, recreation providers, and outdoor enthusiasts across the United States. Phase 1 of this assessment was conducted April 9th – 11th, 2020 (Rice et al., 2020). Phase 2 of this assessment was conducted April 30th – May 2nd. This second phase of research—discussed in this preliminary report— was designed to provide additional information regarding changes in recreation trends since April 9th, which provides valuable information for managing dynamic recreational use on public lands. In total, 823 outdoor recreationists were surveyed through the Leave No Trace community in a 48-hour window beginning on the morning of April 30th. The results of this second rapid assessment—complete with comparisons to Phase 1 data—will provide valuable information for managing the changing recreation use of public lands, predicting spikes in recreation, and offering insight for land managers as they work to protect the natural world.The following tables, figures, and corresponding brief descriptions are intended to provide initial results from Phase 2 of our research effort, with comparisons to Phase 1 when appropriate. Further results are forthcoming.

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A Mobile App Directory of Occupational Therapists Who Provide Home Modifications: Development and Preliminary Usability Evaluation

JMIR Rehabilitation and Assistive Technologies ◽

10.2196/14465 ◽

2020 ◽

Vol 7 (1) ◽

pp. e14465

Author(s):

An Thi Nguyen ◽

Emily Kling Somerville ◽

Sandra Martina Espín-Tello ◽

Marian Keglovits ◽

Susan Lynn Stark

Keyword(s):

Older Adults ◽

Phase 1 ◽

Occupational Therapists ◽

The United States ◽

Mobile App ◽

Community Dwelling ◽

Phase 2 ◽

Home Modifications ◽

The Mean ◽

Community Dwelling Older Adults

Background Home modifications provided by occupational therapists (OTs) are effective in improving daily activity performance and reducing fall risk among community-dwelling older adults. However, the prevalence of home modification is low. One reason is the lack of a centralized database of OTs who provide home modifications. Objective This study aimed to develop and test the usability of a mobile app directory of OTs who provide home modifications in the United States. Methods In phase 1, a prototype was developed by identifying OTs who provide home modifications through keyword Web searches. Referral information was confirmed by phone or email. In phase 2, community-dwelling older adults aged older than 65 years and OTs currently working in the United States were purposefully recruited to participate in a single usability test of the mobile app, Home Modifications for Aging and Disability Directory of Referrals (Home Maddirs). Participants completed the System Usability Scale (SUS) and semistructured interview questions. Interview data were coded, and themes were derived using a grounded theory approach. Results In phase 1, referral information for 101 OTs across 49 states was confirmed. In phase 2, 6 OTs (mean clinical experience 4.3 years, SD 1.6 years) and 6 older adults (mean age 72.8 years, SD 5.0 years) participated. The mean SUS score for OTs was 91.7 (SD 8.0; out of 100), indicating good usability. The mean SUS score for older adults was 71.7 (SD 27.1), indicating considerable variability in usability. In addition, the SUS scores indicated that the app is acceptable to OTs and may be acceptable to some older adults. For OTs, self-reported barriers to acceptability and usability included the need for more information on the scope of referral services. For older adults, barriers included high cognitive load, lack of operational skills, and the need to accommodate sensory changes. For both groups, facilitators of acceptability and usability included perceived usefulness, social support, and multiple options to access information. Conclusions Home Maddirs demonstrates good preliminary acceptability and usability to OTs. Older adults’ perceptions regarding acceptability and usability varied considerably, partly based on prior experience using mobile apps. Results will be used to make improvements to this promising new tool for increasing older adults’ access to home modifications.

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1361. Pharmacokinetics and Safety of Ridinilazole (RDZ), a Potential New Therapy for Clostridium difficile Infection (CDI): From Animal Models to Patients

Open Forum Infectious Diseases ◽

10.1093/ofid/ofy210.1192 ◽

2018 ◽

Vol 5 (suppl_1) ◽

pp. S417-S417

Author(s):

Esther Duperchy ◽

Sumita Chowdhury ◽

Richard Vickers ◽

Neil Robinson

Keyword(s):

Animal Models ◽

Oral Dose ◽

Plasma Levels ◽

Phase 1 ◽

The United States ◽

Whole Body ◽

Oral Drug ◽

Systemic Absorption ◽

Phase 2 ◽

Gi Tract

Abstract Background CDI is the leading cause of nosocomial diarrhea associated with 29,000 deaths p.a. in the United States. RDZ is a novel oral drug highly selective for C. difficile limiting collateral damage to the gut microbiota. Here we present a combined analysis of all pharmacokinetic (PK) and tolerability data obtained throughout the development of RDZ from animal models to Phase 2, including new human PK data. Methods RDZ levels were measured in plasma and in the GI tract of infected hamster after a single oral dose at 25 mg/kg. Quantitative whole-body autoradiography (QWBA) and excretion mass balance studies were performed in rats following a single 50 mg/kg oral dose of 14C RDZ. In GLP toxicology studies, RDZ was administered orally for 28 days to dogs and rats at 1,000 mg/kg/day. Toxicokinetic, clinical pathology, and histopathology analysis were performed. The Phase 1 study enrolled 56 healthy male subjects receiving single ascending doses from 2 to 2,000 mg, or, 200 or 500 mg BID for 10 days. The Phase 2 enrolled 100 patients assigned 1:1 to 10 days oral RDZ 200 mg BID or VAN 125 mg QID treatment. Both clinical trials quantified RDZ in plasma and feces, and assessed safety and tolerability. Results In all animal studies, plasma levels of RDZ were below or at the limit of quantification (LOQ, 1.0 ng/mL). In the GI tract of hamsters, RDZ levels were highest in the colon. QWBA and excretion studies showed RDZ accumulated in the cecum and colon, the site of infection; >99% of radioactivity was excreted in feces and no radioactivity was detected systemically. 28 days repeat dosing in dog and rat resulted in no observations from treatment, histopathology or in-life parameters. In Phase 1 and 2 studies, RDZ plasma levels were generally near or below the LOQ (0.1 ng/mL). Concomitant medications, CDI severity, and age had no impact on exposure. In Phase 1, AEs were mild with no dose-dependent relationship, occurring and at a similar incidence to placebo. No significant findings from clinical laboratory, ECGs or other assessment were observed. RDZ was well tolerated in Phase 2 with the incidence of AEs and SAEs similar in both RDZ and VAN groups. Conclusion In both clinical and nonclinical studies to date, RDZ has been well tolerated and associated with low systemic absorption. Further assessment of safety, tolerability, and PK in Phase 3 studies is warranted. Disclosures E. Duperchy, Summit Therapeutics: Employee, Salary. S. Chowdhury, Summit Therapeutics Inc.: Employee and Shareholder, Salary and Shareholder. R. Vickers, Summit Therapeutics: Employee, Salary and Stock options. N. Robinson, Summit Therapeutics: Consultant, Consulting fee.

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Impact of replacing regular chocolate milk with the reduced-sugar option on milk consumption in elementary schools in Saskatoon, Canada

Applied Physiology Nutrition and Metabolism ◽

10.1139/apnm-2015-0501 ◽

2016 ◽

Vol 41 (5) ◽

pp. 511-515 ◽

Cited By ~ 7

Author(s):

Carol Henry ◽

Susan J. Whiting ◽

Sarah L. Finch ◽

Gordon A. Zello ◽

Hassan Vatanparast

Keyword(s):

Elementary Schools ◽

Phase 1 ◽

Milk Consumption ◽

Chocolate Milk ◽

Phase 2 ◽

Older Children ◽

Older Students ◽

Sugar Consumption

Excess sugar consumption in children has led to the removal of chocolate milk from some schools. Lower-sugar formulations, if accepted, would provide the benefits of milk consumption. In a cross-over trial, milk consumption was measured in 8 schools over 6 weeks in 2 phases: phase 1 provided standard 1% chocolate milk and plain 2% milk choices for the first 3 weeks, and phase 2 provided reduced-sugar 1% chocolate milk and plain 2% milk for the next 3 weeks. Milk selection and milk wasted were measured by sex and grade (1–8). Children chose chocolate milk more often than white milk in both phases (phase 1, 8.93% ± 0.75% vs. 0.87% ± 0.11% (p < 0.001), and phase 2, 5.76% ± 0.29% vs. 0.78% ± 0.14% (p < 0.001), respectively). Fewer children chose reduced-sugar chocolate milk in phase 2 (p < 0.001). A greater percentage of younger students (grades 1–4) than older students (grades 5–8) purchased milk in both phases (phase 1, 11.10% ± 0.81% vs. 8.36% ± 0.74%, p = 0.020, and phase 2, 8.47% ± 0.43% vs. 4.62% ± 0.40%, p < 0.001, respectively); older children drank more milk at lunch. Schoolchildren preferred chocolate milk over plain milk even when a reduced-sugar formula was offered; however, switching to reduced-sugar chocolate milk led to a decrease in the number of students choosing milk. Longer-duration studies are required to determine if students would purchase reduced-sugar chocolate milk at the same rate as they would purchase regular chocolate milk.

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A Population-Based Study of Peyronie's Disease: Prevalence and Treatment Patterns in the United States

Advances in Urology ◽

10.1155/2011/282503 ◽

2011 ◽

Vol 2011 ◽

pp. 1-9 ◽

Cited By ~ 111

Author(s):

Dana Britt DiBenedetti ◽

Dat Nguyen ◽

Laurie Zografos ◽

Ryan Ziemiecki ◽

Xiaolei Zhou

Keyword(s):

Health Care Professionals ◽

Phase 1 ◽

The United States ◽

Treatment Patterns ◽

Care Physician ◽

Peyronie’S Disease ◽

Phase 2 ◽

Patient Reported ◽

The Us ◽

Peyronie's Disease

Purpose. To estimate the US prevalence of Peyronie's disease (PD) from patient-reported data and to identify diagnosis and treatment patterns.Methods. 11,420 US males ≥18 years old completed a brief web-based survey regarding the presence of PD, past treatments, and penile symptoms (Phase 1). Phase 1 respondents with PD diagnosis, history of treatment, or PD-related symptoms then completed a disease-specific survey (Phase 2).Results. Estimated prevalence of PD ranged from 0.5% (diagnosis of PD) to 13% (diagnosis, treatment, or penile symptoms). Thirty-six percent of Phase 2 participants reported that penile symptoms interfered with sexual activities. Of participants who sought treatment for penile symptoms (), 73% initially saw a primary care physician, 74% did not receive treatment from their first doctor, and 92% were not diagnosed with PD.Conclusions. PD may be underdiagnosed/undertreated in the US. Improved awareness is needed of PD symptoms and treatment options among health care professionals.

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A Mobile App Directory of Occupational Therapists Who Provide Home Modifications: Development and Preliminary Usability Evaluation (Preprint)

10.2196/preprints.14465 ◽

2019 ◽

Author(s):

An Thi Nguyen ◽

Emily Kling Somerville ◽

Sandra Martina Espín-Tello ◽

Marian Keglovits ◽

Susan Lynn Stark

Keyword(s):

Older Adults ◽

Phase 1 ◽

Occupational Therapists ◽

The United States ◽

Mobile App ◽

Community Dwelling ◽

Phase 2 ◽

Home Modifications ◽

The Mean ◽

Community Dwelling Older Adults

BACKGROUND Home modifications provided by occupational therapists (OTs) are effective in improving daily activity performance and reducing fall risk among community-dwelling older adults. However, the prevalence of home modification is low. One reason is the lack of a centralized database of OTs who provide home modifications. OBJECTIVE This study aimed to develop and test the usability of a mobile app directory of OTs who provide home modifications in the United States. METHODS In phase 1, a prototype was developed by identifying OTs who provide home modifications through keyword Web searches. Referral information was confirmed by phone or email. In phase 2, community-dwelling older adults aged older than 65 years and OTs currently working in the United States were purposefully recruited to participate in a single usability test of the mobile app, Home Modifications for Aging and Disability Directory of Referrals (Home Maddirs). Participants completed the System Usability Scale (SUS) and semistructured interview questions. Interview data were coded, and themes were derived using a grounded theory approach. RESULTS In phase 1, referral information for 101 OTs across 49 states was confirmed. In phase 2, 6 OTs (mean clinical experience 4.3 years, SD 1.6 years) and 6 older adults (mean age 72.8 years, SD 5.0 years) participated. The mean SUS score for OTs was 91.7 (SD 8.0; out of 100), indicating good usability. The mean SUS score for older adults was 71.7 (SD 27.1), indicating considerable variability in usability. In addition, the SUS scores indicated that the app is acceptable to OTs and may be acceptable to some older adults. For OTs, self-reported barriers to acceptability and usability included the need for more information on the scope of referral services. For older adults, barriers included high cognitive load, lack of operational skills, and the need to accommodate sensory changes. For both groups, facilitators of acceptability and usability included perceived usefulness, social support, and multiple options to access information. CONCLUSIONS Home Maddirs demonstrates good preliminary acceptability and usability to OTs. Older adults’ perceptions regarding acceptability and usability varied considerably, partly based on prior experience using mobile apps. Results will be used to make improvements to this promising new tool for increasing older adults’ access to home modifications.

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Prognosticating Mesothelioma Using Predictive Analytics

10.20944/preprints201908.0061.v1 ◽

2019 ◽

Author(s):

Avishek Choudhury

Keyword(s):

Classification Accuracy ◽

Mean Squared Error ◽

Predictive Analytics ◽

Phase 1 ◽

The United States ◽

Support Vector ◽

Pleural Mesothelioma ◽

Phase 2 ◽

Duration Of Symptoms ◽

Adaptive Boosting

Background: Malignant pleural mesothelioma (MPM) is an atypical, belligerent tumor that matures into cancer in the pleura, a stratum of tissue bordering the lungs. Pleural mesothelioma is a common type of mesothelioma that accounts for about 75 percent of all mesothelioma diagnosed yearly in the United States. Diagnosis of mesothelioma takes several months and is expensive. Given the difficulty of diagnosing MPM, early identification is crucial for patient survival. Our study implements artificial intelligence and recommends the best fit model for early diagnosis and prognosis of MPM. Method: We retrospectively retrieved patient’s medical reports generated by Dicle University, Turkey and implemented multi-layered perceptron (MLP), voted perceptron (VP), Clojure classifier (CC), kernel logistic regression (KLR), stochastic gradient decent SGD), adaptive boosting (AdaBoost), Hoeffding tree (VFDT), and primal estimated sub-gradient solver for support vector machine (s-Pegasos). We evaluated the models, compared and tested using paired T-test (corrected) at 0.05 significance based on their respective classification accuracy, f-measure, precision, recall, root mean squared error, receivers characteristic curve (ROC), and precision-recall curve (PRC). Results: In phase-1 SGD, AdaBoost.M1, KLR, MLP, VFDT generates optimal results with the highest possible performance measures. In phase-2, AdaBoost with a classification accuracy of 71.29% outperformed all other algorithms. C-reactive protein, platelet count, duration of symptoms, gender, and pleural protein were found to be the most relevant predictors that can prognosticate mesothelioma. Conclusion: This study confirms that data obtained from biopsy and imagining tests are strong predictors of mesothelioma but are associated with high cost, however, can identify mesothelioma with optimal accuracy. Predictive analytics without using biopsy results can diagnose mesothelioma with acceptable accuracy. Implementation of phase-2 followed by phase-1 can address diagnosis expenses and maximize disease prognosis. Additionally, results indicate improved MPM diagnosis using AI methods dependent upon the specific application.

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A Phase 1/2 Study to Evaluate the Safety and Efficacy of Ponatinib with Chemotherapy in Pediatric Patients with Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL)

Blood ◽

10.1182/blood-2020-134724 ◽

2020 ◽

Vol 136 (Supplement 1) ◽

pp. 47-47

Author(s):

Yousif Matloub ◽

Lia Gore ◽

Mignon L. Loh ◽

Chin-Hon Pui ◽

Michael J. Hanley ◽

...

Keyword(s):

Board Of Directors ◽

Pediatric Patients ◽

Phase 1 ◽

The United States ◽

Advisory Board ◽

Marketing Approval ◽

Phase 2 ◽

Advisory Committees ◽

Free Survival ◽

Secondary Endpoints

Introduction: Ph+ ALL accounts for 3-5% of pediatric ALL and is associated with improved outcomes when tyrosine kinase inhibitors (TKIs) are added to chemotherapy, with 5-year event-free survival (EFS) and overall survival (OS) of 58-60% and 70-86%, respectively. Ponatinib is a potent third-generation TKI pan-BCR-ABL1 inhibitor that is active against BCR-ABL1 and all identified single resistance mutations, including the gatekeeper alteration, T315I, which confers resistance to other TKIs. Ponatinib has marketing approval in more than 50 countries, which includes the United States and European Union, for adults with chronic-/accelerated-/blast-phase chronic myeloid leukemia or Ph+ ALL that are resistant/intolerant to other TKIs or are T315I+. Ponatinib may also overcome drug resistance in pediatric patients with relapsed or resistant Ph+ ALL. This study will assess the pharmacokinetics, safety, and efficacy of ponatinib in pediatric patients. Methods: This Phase 1/2, single-arm, open-label, multicenter study (NCT04501614) will enroll approximately 18 patients in Phase 1 and 68 patients in Phase 2, including those enrolled in Phase 1 at the recommended Phase 2 dose (RP2D). Patients (aged ≥1 year to ≤21 years) with Ph+ ALL, Ph+ mixed phenotype acute leukemia, or Ph-like ALL (US only) with ABL class lesions will be enrolled. Enrolled patients must have either relapsed or are resistant or intolerant to ≥1 prior therapy with a BCR-ABL1-targeted TKI or have a BCR-ABL1 T315I mutation. Patients >16 years must have a Karnofsky performance status ≥50%; patients ≤16 years must have a Lansky Play Scale ≥50%. During Phase 1, prior to availability of an age-appropriate formulation (AAF), patients must weigh ≥30 kg and be able to swallow tablets. The Phase 1 study will establish the RP2D of ponatinib in combination with the chemotherapy backbone using the adult tablet formulation in patients able to swallow tablets. Patients will receive fixed doses of ponatinib based on body weight ranges. The initially selected doses are expected to achieve systemic exposures that approximately match adult exposures after a 30-mg dose. Dose selection for the AAF will be in a separate cohort and informed by the results of a relative bioavailability study in healthy adult volunteers. A rolling 6 design will be used for both cohorts; additional cohorts may be enrolled at lower or higher doses based on the emerging data. In both Phase 1 and Phase 2, patients will receive two 35-day blocks of therapy (reinduction and consolidation). Each block includes 29 days of study treatment consisting of daily ponatinib and a modified United Kingdom ALL R3 chemotherapy backbone regimen, followed by a rest period of at least 6 days with daily ponatinib only. Disease assessment will occur at the end of each block. Patients will undergo an end-of-treatment visit 25 to 30 days after the last dose of study treatment in the consolidation block, or earlier if the patient is proceeding to alternate therapy or optional ponatinib continuation therapy. For the Phase 1 study, the primary endpoint is the RP2D of ponatinib (tablet and AAF) in combination with chemotherapy. Secondary endpoints are complete response (CR) rate at the end of the reinduction block and characterization of BCR-ABL1 domain mutations prior to and following ponatinib treatment. For the Phase 2 study, the primary endpoint is the CR rate at the end of the reinduction block. Secondary endpoints will be summarized descriptively, and include the proportion of patients in continued CR or who achieve CR at the end of consolidation, the proportion with minimal residual disease-negative status <0.01% at the end of each block, and the proportion who relapsed or progressed, and time-to-event estimates including EFS, progression-free survival, and OS. The study will include approximately 70 study sites in approximately 16 countries. Disclosures Matloub: Takeda: Current Employment. Gore:Amgen, Novartis, Roche: Membership on an entity's Board of Directors or advisory committees. Loh:Medisix Therapeutics: Membership on an entity's Board of Directors or advisory committees; Pfizer: Other: Institutional Research Funding. Pui:Adaptive Biotechnologies: Membership on an entity's Board of Directors or advisory committees. Hanley:Takeda: Current Employment. Lu:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Current Employment. Leonard:Takeda: Current Employment. Granier:Incyte: Current Employment. Silverman:Servier: Other: advisory board; Syndax: Other: advisory board; Takeda: Other: advisory board. OffLabel Disclosure: Ponatinib has marketing approval in the United States and European Union for adult patients with chronic-/accelerated-/blast-phase chronic myeloid leukemia or Ph+ ALL that are resistant/intolerant to other TKIs or are T315I+. This trials-in-progress abstract describes a study in pediatric patients.

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175. Assessment of Institutional Uptake of Vancomycin AUC Monitoring One-Year Post Guideline Publication in Hospitals Across the United States

Open Forum Infectious Diseases ◽

10.1093/ofid/ofab466.377 ◽

2021 ◽

Vol 8 (Supplement_1) ◽

pp. S196-S197

Author(s):

Nicole Bradley ◽

Yuman Lee ◽

Ariel E Francis ◽

Duchess Iregbulem

Keyword(s):

Phase 1 ◽

The United States ◽

Research Network ◽

Therapeutic Monitoring ◽

Phase 2 ◽

Chi Square ◽

Initial Survey ◽

American Society ◽

One Year ◽

The Impact

Abstract Background A new therapeutic monitoring of vancomycin for serious methicillin resistant Staphylococcus aureus infections guideline was published in March 2020. The guideline recommends a change in monitoring from trough to AUC/MIC based to improve patient outcomes. The purpose of this study was to determine institutional uptake of vancomycin AUC monitoring 1-year post guideline publication in hospitals across the U.S. Methods An electronic survey was created to assess vancomycin AUC monitoring practices and distributed to the American College of Clinical Pharmacy Infections Diseases Practice and Research Network (ACCP IDprn) and American Society of Health System Pharmacists (ASHP). Initial survey distribution (phase 1) occurred May-June 2020 and aimed to serve as baseline data. The survey was re-distributed (phase 2) to the ACCP IDprn and ASHP one year later, May-June 2021. Prior to re-distribution the survey was updated to assess the impact of COVID-19 on uptake. Results were analyzed and reported using descriptive statistics. Chi-Square tests were used to compare categorical data. Results A total of 202 responses to phase 1 and 138 responses to phase 2 were recorded. Significantly more respondents implemented AUC monitoring 1-year post guideline than at baseline (42.8% vs 29.8%, p= 0.013). In both phases, 57% of those who had not implemented AUC monitoring had plans to do so over the next year. Additionally, 46.2% phase 2 respondents reported COVID-19 impacted their ability to transition to AUC monitoring citing issues such as lack of time and inadequate resources. The most common AUC monitoring programs utilized at baseline and 1-year post guideline were purchased Bayesian software (38.3% vs. 35.6%) and homemade software (26.1% vs 23.7%). Perceived challenges to implementing AUC monitoring included cost, difficult use and integration. Conclusion Increased uptake of vancomycin AUC monitoring occurred from baseline to 1-year post guideline publication. However, less than half of hospitals implemented this recommendation. Although COVID-19 impacted a large portion respondents’ ability to implement AUC monitoring, majority plan to transition to vancomycin AUC monitoring over the next year. AUC monitoring should be adapted by all hospitals to optimize vancomycin efficacy and safety. Disclosures All Authors: No reported disclosures

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