Patient-Centered Outcomes Research Institute Research Articles

Abstract PO4-13-04: Added Value from Patient Advocates in a Translational Working Group: the COMET Study

Abstract Introduction: A phase III multicenter prospective randomized clinical trial called “Comparing an Operation to Monitoring, with or without Endocrine Therapy (COMET)” (NCT02926911) assesses the risks/benefits of active monitoring (AM) versus surgery for women with low-risk ductal carcinoma in situ (DCIS). It is funded by the Patient-Centered Outcomes Research Institute and enrolled 997 women between 06/30/17 and 01/13/23. Research Patient Advocates (PAs) have been embedded from the study design stage and continue to provide guidance as part of the COMET leadership team. The COMET biobank is funded by independent foundations and is managed through monthly Translational Working Group (TWG) meetings. The TWG includes PAs, clinicians, pathologists, radiologists, and researchers from multiple institutions who discuss topics like categorization of biospecimens into discovery/validation sets; development of a pathology workflow/sample tracking process; use of small samples; and potential areas of future research/technologies that may improve DCIS diagnostics, prognostics, and care management. Methods: The TWG leveraged the existing Alliance Foundation Trials, LLC biobank infrastructure and facilitates the collection, submission, storage and analysis/use of blood, tissue, and breast images collected at specified timepoints and stored in central tissue/image repositories. PAs are active and integral in the TWG, assisting with logistical issues (contracts, transfer agreements, resource requests); communicating with sites; identifying study topics and biomarkers relevant to diverse patients; providing guidance on commercial predictive/prognostic tests; promoting effective stewardship of samples; ensuring overall focus remains on advancing clinical utility; and reporting translational study results to trial participants who agreed to donate samples/images. Results: Over 90% of requested samples/images have been submitted by ˃85 sites. Each patient’s biospecimens and pathology images are linked and de-identified for research. Use of artificial intelligence (AI) is being considered to assist in sample review. TWG members have complementary areas of expertise/experience and promote active stewardship for effective management of these scarce resources. PAs have played key roles concerning equitable data-sharing and acceleration of data and material transfer agreements. They have also been active in development of standards for discovery/training sets, validation test sets; communication procedures for patient cases that progress to future breast events; ways to catalog technologies (e.g., multi-omics, AI); and in research proposal review. Consensus has been achieved regarding major issues such as authorship, biospecimen custodianship, intellectual property, and criteria relevant to patient needs. Logistical barriers, including data sharing and technicalities of biospecimen release, have been resolved. The TWG also played an integral role in resolving recruitment challenges to COMET by creating standard pathology eligibility criteria, resulting in evidence-based protocol amendments that increased accrual. A retrospective review of biospecimens has been performed to determine adequacy for ensuing correlative molecular and spatial profiling studies. Conclusion: PAs help the COMET TWG set policy, and oversee biospecimen/image collection, and biobank use and sharing. PA input also facilitates equitable, transparent research studies and technology development that can improve personalized decisions for surgery versus AM in women with low-risk DCIS. PAs in the TWG aim to integrate the diagnostic and prognostic tools developed as part of the COMET study into future patient care. Citation Format: Deborah Collyar, Desiree Basila, Thomas Lynch, Stuart Schnitt, Jeffrey Marks, Siri Strand, Terry Hyslop, Sunil Badve, Mark Watson, H. T. Carisa Le-Petross, Lars Grimm, Robert West, Anna Weiss, Anna Rapperport, Lorraine King, Rachel Factor, Marc Ryser, Ann Partridge, E Shelley Hwang, Alastair Thompson. Added Value from Patient Advocates in a Translational Working Group: the COMET Study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-13-04.

An Overview of the Methodology Used to Develop Clinical Practice Guidelines for the Management of Acute and Intraoperative Spinal Cord Injury.

An overview of the methods used to develop clinical practice guidelines (CPGs). Acute spinal cord injury (SCI) and intraoperative SCI (ISCI) can have devastating physical and psychological consequences for patients and their families. To date, there are several studies that have discussed the diagnostic and management strategies for both SCI and ISCI. CPGs in SCI help to distill and translate the current evidence into actionable recommendations, standardize care across centers, optimize patient outcomes, and reduce costs and unnecessary interventions. Furthermore, they can be used by patients to assist in making decisions about certain treatments and by policy makers to inform allocation of resources. The objective of this article is to summarize the methods used to develop CPGs for the timing of surgery and hemodynamic management of acute SCI, as well as the identification and treatment of ISCI. The CPGs were developed using standards established by the Institute of Medicine (now the National Academy of Medicine), the Guideline International Network and several other organizations. Systematic reviews were conducted according to accepted methodological standards (eg, Institute of Medicine, Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute) in order to summarize the current body of evidence and inform the guideline development process. Protocols for each guideline were created. A multidisciplinary guideline development group (GDG) was formed that included individuals living with SCI as well as clinicians from the broad range of specialties that encounter patients with SCI: spine or trauma surgeons, critical care physicians, rehabilitation specialists, neurologists, anesthesiologists and other healthcare professionals. Individuals living with SCI were also included in the GDG. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach was used to rate the certainty of the evidence for each critical outcome. The "evidence to recommendation" framework was then used to translate the evidence obtained from the systematic review to an actionable recommendation. This framework provides structure when assessing the body of evidence and considers several additional factors when rating the strength of the recommendation, including the magnitude of benefits and harms, patient preferences, resource use, health equities, acceptability and feasibility. Finally, the CPGs were appraised both internally and externally. The results of the CPGs for SCI are provided in separate articles in this focus issue. Development of these CPGs for SCI followed the methodology proposed by the Institute of Medicine the Guideline International Network and the GRADE Working Group. It is anticipated that these CPGs will assist clinicians implement the best evidence into practice and facilitate shared-decision making with patients.

Raising the Bar for Real-World Data in Oncology: Approaches to Quality Across Multiple Dimensions.

Electronic health record (EHR)-based real-world data (RWD) are integral to oncology research, and understanding fitness for use is critical for data users. Complexity of data sources and curation methods necessitate transparency into how quality is approached. We describe the application of data quality dimensions in curating EHR-derived oncology RWD. A targeted review was conducted to summarize data quality dimensions in frameworks published by the European Medicines Agency, The National Institute for Healthcare and Excellence, US Food and Drug Administration, Duke-Margolis Center for Health Policy, and Patient-Centered Outcomes Research Institute. We then characterized quality processes applied to curation of Flatiron Health RWD, which originate from EHRs of a nationwide network of academic and community cancer clinics, across the summarized quality dimensions. The primary quality dimensions across frameworks were relevance (including subdimensions of availability, sufficiency, and representativeness) and reliability (including subdimensions of accuracy, completeness, provenance, and timeliness). Flatiron Health RWD quality processes were aligned to each dimension. Relevancy to broad or specific use cases is optimized through data set size and variable breadth and depth. Accuracy is addressed using validation approaches, such as comparison with external or internal reference standards or indirect benchmarking, and verification checks for conformance, consistency, and plausibility, selected on the basis of feasibility and criticality of the variable to the intended use case. Completeness is assessed against expected source documentation; provenance by recording data transformation, management procedures, and auditable metadata; and timeliness by setting refresh frequency to minimize data lags. Development of high-quality, scaled, EHR-based RWD requires integration of systematic processes across the data lifecycle. Approaches to quality are optimized through knowledge of data sources, curation processes, and use case needs. By addressing quality dimensions from published frameworks, Flatiron Health RWD enable transparency in determining fitness for real-world evidence generation.

Comparative effectiveness of azathioprine and mycophenolate mofetil for myasthenia gravis (PROMISE-MG): a prospective cohort study

Myasthenia gravis is an autoimmune disorder of the neuromuscular junction. Treatment typically includes symptomatic oral cholinesterase inhibitors, immunosuppression, and immunomodulation. In addition to corticosteroids, azathioprine and mycophenolate mofetil are the most frequently used immunosuppressants in North America. We aimed to evaluate the comparative effectiveness of these two drugs, and to assess the effect of the dose and duration of treatment. We did a prospective cohort study at 19 academic centres in Canada and the USA. We included patients (aged ≥18 years) with autoimmune myasthenia gravis, who were never treated with immunosuppressants. Treating clinicians determined the choice of medication, dose, follow-up intervals, and drug monitoring. Outcome measures and adverse events were recorded at each visit. We assessed two co-primary outcomes. The first was the patient-reported Myasthenia Gravis-Quality of Life 15-revised (MGQOL-15r) score, measured as the mean change from treatment initiation to the follow-up visit with the lowest score. A clinically meaningful reduction (CMR) in MGQOL-15r was defined as a 5-point decrease. The second was a composite clinical outcome of disease improvement (Myasthenia Gravis Foundation of America Post-Intervention Status Minimal Manifestations or better) and low adverse event burden (defined as grade ≤1 Common Terminology Criteria for Adverse Events). We also compared these outcomes in patients receiving an adequate dose and duration of azathioprine (≥2 mg/kg per day for at least 12 months) or mycophenolate mofetil (≥2 g per day for at least 8 months) and a lower dose or shorter duration of these agents. We used propensity score weighting with generalised linear regression models. This study is registered with ClinicalTrials.gov (NCT03490539). Between May 1, 2018, and Aug 31, 2020, 167 patients were enrolled; 85 did not receive azathioprine or mycophenolate mofetil and were excluded. Four were excluded from outcome analyses because they had scores of 0 on an outcome measure at treatment initiation. Of the 78 patients included in analyses, 47 received mycophenolate mofetil (median follow-up 25 months [IQR 13·5-31·5]) and 31 received azathioprine (median follow-up 20 months [IQR 13-30]). The mean change in MG-QOL15r was -10·4 (95% CI -18·9 to -1·3) with mycophenolate mofetil and -6·8 (-17·2 to 3·6) with azathioprine (mean difference -3·3, 95% CI -7·7 to 1·2; p=0·15). 38 (81%) of 47 patients receiving mycophenolate mofetil and 18 (57%) of 31 receiving azathioprine had a CMR in MG-QOL15r (risk difference 24·0%; 95% CI -0·2 to 48·0; p=0·052). The clinical composite outcome was achieved in 22 (47·7%) of 47 patients who received mycophenolate mofetil and nine (28·1%) of 31 who received azathioprine (risk difference 19·6%, 95% CI -4·9 to 44·2; p=0·12). Descriptive analysis did not find a difference in the proportion of patients reaching a CMR in MG-QOL15r between the adequate dose and duration group and the lower dose or shorter duration group. Adverse events occurred in 11 (32%) of 34 patients who received azathioprine and nine (19%) of 48 who received mycophenolate mofetil. The most frequent adverse events were hepatotoxicity with azathioprine (five [15%] of 34) and gastrointestinal disturbances (seven [15%] of 48) with mycophenolate mofetil. There were no study-related deaths. More than half of patients treated with azathioprine and mycophenolate mofetil felt their quality of life improved; no difference in clinical outcomes was noted between the two drugs. Adverse events associated with azathioprine were potentially more serious than those with mycophenolate mofetil, although mycophenolate mofetil is teratogenic. Lower than recommended doses of azathioprine might be effective, with reduced dose-dependent adverse events. More comparative effectiveness studies are required to inform treatment choices in myasthenia gravis. Patient-Centered Outcomes Research Institute, Myasthenia Gravis Foundation of America.

Skin Antisepsis before Surgical Fixation of Extremity Fractures

BackgroundStudies evaluating surgical-site infection have had conflicting results with respect to the use of alcohol solutions containing iodine povacrylex or chlorhexidine gluconate as skin antisepsis before surgery to repair a fractured limb (i.e., an extremity fracture).MethodsIn a cluster-randomized, crossover trial at 25 hospitals in the United States and Canada, we randomly assigned hospitals to use a solution of 0.7% iodine povacrylex in 74% isopropyl alcohol (iodine group) or 2% chlorhexidine gluconate in 70% isopropyl alcohol (chlorhexidine group) as preoperative antisepsis for surgical procedures to repair extremity fractures. Every 2 months, the hospitals alternated interventions. Separate populations of patients with either open or closed fractures were enrolled and included in the analysis. The primary outcome was surgical-site infection, which included superficial incisional infection within 30 days or deep incisional or organ-space infection within 90 days. The secondary outcome was unplanned reoperation for fracture-healing complications.ResultsA total of 6785 patients with a closed fracture and 1700 patients with an open fracture were included in the trial. In the closed-fracture population, surgical-site infection occurred in 77 patients (2.4%) in the iodine group and in 108 patients (3.3%) in the chlorhexidine group (odds ratio, 0.74; 95% confidence interval [CI], 0.55 to 1.00; P=0.049). In the open-fracture population, surgical-site infection occurred in 54 patients (6.5%) in the iodine group and in 60 patients (7.3%) in the chlorhexidine group (odd ratio, 0.86; 95% CI, 0.58 to 1.27; P=0.45). The frequencies of unplanned reoperation, 1-year outcomes, and serious adverse events were similar in the two groups.ConclusionsAmong patients with closed extremity fractures, skin antisepsis with iodine povacrylex in alcohol resulted in fewer surgical-site infections than antisepsis with chlorhexidine gluconate in alcohol. In patients with open fractures, the results were similar in the two groups. (Funded by the Patient-Centered Outcomes Research Institute and the Canadian Institutes of Health Research; PREPARE ClinicalTrials.gov number, NCT03523962.)

Making progress against rare cancers: A case study on neuroendocrine tumors.

In April 2023, the National Cancer Institute offered a roadmap for cancer research to achieve Cancer Moonshot goals. To reach these goals requires making progress for all cancers, not just those that are most common. Achieving progress against rare cancers, as well as common cancers, requires involvement of large clinical research networks. In 2020, the Patient-Centered Outcomes Research Institute (PCORI) launched an initiative on Conducting Rare Disease Research using PCORnet, the National Patient-Centered Clinical Research Network. The purpose of this commentary is to introduce the broader community of cancer researchers to the PCORnet NET-PRO study (comparing the effects of different treatment approaches for neuroendocrine tumors on patient-reported outcomes) thereby demonstrating how researchers can use the PCORnet infrastructure to conduct large-scale patient-centered studies of rare cancers.

How Do Consumers Interact with Digital Expert Advice? Experimental Evidence from Health Insurance

Consumers increasingly use digital advice when making purchasing decisions. How do such tools change consumer behavior and what types of consumers are likely to use them? We examine these questions with a randomized controlled trial of digital expert advice in the context of prescription drug insurance. The intervention we study was effective at changing consumer choices. We propose that, conceptually, expert advice can affect consumer choices through two distinct channels: by updating consumer beliefs about product features (learning) and by influencing how much consumers value product features (interpretation). Using our trial data to estimate a model of consumer demand, we find that both channels are quantitatively important. Digital expert advice tools not only provide consumers with information, but also alter how consumers value product features. For example, consumers are willing to pay 14% less for a plan with the most popular brand and 37% less for an extra star rating when they incorporate digital expert advice on plan choice relative to only having information about product features. Further, we document substantial selection into the use of digital advice on two margins. Consumers who are inherently less active shoppers and those who we predict would have responded to advice more were less likely to demand it. Our results raise concerns regarding the ability of digital advice to alter consumer preferences as well as the distributional implications of greater access to digital expert advice. This paper was accepted by Stefan Scholtes, healthcare management. Funding: This work was supported by the National Institute on Aging [Grant K01AG059843] and the Patient-Centered Outcomes Research Institute [Grant CDR-1306-03598]. The project also received financial support from Stanford Innovation Funds. Supplemental Material: The online appendix and data files are available at https://doi.org/10.1287/mnsc.2020.02453 .

Engaging patients and stakeholders to identify a research agenda to support social determinants of health (SDOH) screening and intervention initiatives in community pharmacy

Community pharmacists can play a vital role in supporting the nation’s effort to address patients’ social needs at a scalable, system-wide level. However, evidence is scarce related to the acceptability, and effectiveness of existing programs that administer social determinants of health (SDOH) screening and referral interventions. The Pharmacy Quality Alliance and National Patient Advocate Foundation convened a multistakeholder panel consisting of patient and pharmacy stakeholders in 2022 to develop a patient-centered outcomes research (PCOR) agenda for community pharmacies. Guided by the Patient-Centered Outcomes Research Institute’s Engagement Rubric, the series of three workshops sought to amplify the patient voice throughout the process. Identified priorities include research to support the development of infrastructure required to incorporate SDOH screening and intervention programs into existing workflows; defining the feasibility of screening and interventions in the community pharmacy setting; and understanding patient perception and preferences on communication strategies, educational outreach efforts, and appropriate handling of sensitive information related to social needs. Pharmacy stakeholders emphasized the importance of generating evidence to demonstrate the effectiveness of programs to support the development of reimbursement strategies aimed at the long-term sustainability of effective programs. Developing patient and community collaborations and integrating efforts with other healthcare professionals is going to be vital to minimize care fragmentation and maximize the healthcare system’s overall ability to address patients’ social needs. Future research efforts should examine the impact of multisectoral collaboration to address patients’ social needs, patient experience with the interventions, and the effectiveness of the interventions themselves.

BUILDING BRIDGES AND CATALYZING RESEARCH FOR EVIDENCE-BASED INFECTION CONTROL: PROJECT ECHO FOR NURSING HOMES

Abstract Nursing homes were ill-equipped for the pandemic; though facilities are required to have infection control staff, only 3% have taken a basic infection control course. Significant research has focused on infection control in the acute care setting; however, little is known about the implementation of infection control practices in long-term care communities. In this symposium, we will describe findings from the Project ECHO for Nursing Homes- a national, Patient-Centered Outcomes Research Institute (PCORI) funded study. First, Dr. Kraschnewski will present over all study findings from the stratified, cluster randomized controlled trial of 136 nursing homes that participated in up to 33 weeks of best-practice training to improve COVID-19 infection control practices. Next, Dr. Calo will present on implementation outcomes at 6-months including readiness for change and the implementation climate in the NH. Next, Ms. Heilbrunn will discuss the impacts of implementing evidence-based infection control practices through COVID-19 on NH residents’ well-being. Finally, Dr. Behrens will describe NH leadership perspectives (n=14) on preparing and maintaining care quality during times of diminishing resources. Data presented in this symposium can guide NHs in strategies to implement evidence-based infection control in their homes and informs researchers who are looking to implement similar implementation studies in the NH setting.

Abstract A049: Community partnership to empower Black men to drive research to identify barriers to prostate cancer early detection and equitable care

Abstract Introduction: Black men have a two-fold higher rate of prostate cancer death in the US compared with other men, the largest racial inequity in US cancer-related deaths. Annual PSA testing among Black men starting at age 45 years would reduce mortality compared with current screening practices. However, the US Preventive Service Task Force (USPSTF) guidelines do not make screening recommendations specifically for Black men. Black men comprised only 0-3% of practice-informing PSA screening trial cohorts. Given the burden of prostate cancer among Black men, capacity must be built to empower Black men and their communities to develop and execute clinical trials that may provide guidance on early detection strategies. Methods: We conducted semi-structured interviews to examine prostate cancer screening access among Black men in the Pacific Northwest, and we surveyed primary care physicians (PCPs) and urologists in the Washington, Wyoming, Alaska, Montana, and Idaho (WWAMI) region to assess knowledge, attitudes, and practices about prostate cancer screening. Interviews were recorded and transcribed; consensus coding and thematic analysis were used to identify structural barriers associated with screening access. Anonymous online surveys were distributed to physicians via email using REDCap. Results: 29 men participated in semi-structured interviews. We identified three equity-related barriers related to prostate cancer screening access: (1) lack of information on the benefits and harms of prostate cancer screening, (2) lack of PCP knowledge about prostate cancer disparities confronted by Black men, and (3) lack of trusted relationships with PCPs to support shared decision-making about prostate cancer screening. 32 urologists and 31 PCPs completed the survey. Nearly all urologists and PCPs were aware of the 2018 USPSTF guidelines regarding PSA testing (93.8% and 96.7%, respectively). 75% of urologists and 6.5% of PCPs agreed that PSA testing can significantly reduce prostate cancer mortality. Conclusion: Findings from the survey support the perception reported by interviewees that there is variation in knowledge and support for prostate cancer screening for early detection of prostate cancer among Black men. Our combined findings further demonstrate that (1) Black men have unique needs around early detection of prostate cancer and (2) patient partnerships can identify these areas of need and best inform patient-centered design of practice-changing research studies. Future Directions: With funding from the Patient Centered Outcomes Research Institute we will apply these findings by (1) building engagement and research capacity among a cohort of Black men with a history of prostate cancer and their advocates, (2) identifying community derived research priorities around the early detection of prostate cancer in Black men, and (3) developing a research agenda to inform future large, patient-centered, comparative effectiveness clinical trials in early detection of prostate cancer in Black men. Citation Format: Jenney R. Lee, Dante' Morehead, Ben Young, Victor Tolbert, John Masambe, Garrett Britt, Lars Neuenschwander, Kyle Schuppe, Richard Pelman, Debi Johnson, Sung Min Kim, Erika M. Wolff, John L. Gore, Yaw A. Nyame. Community partnership to empower Black men to drive research to identify barriers to prostate cancer early detection and equitable care [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A049.

Real-World Implementation of Sickle Cell Transition Programs As Part of a State Quality Improvement Network

The Florida Department of Health's Division of Children's Medical Services administers, with facilitation service from the National Institute for Children's Health Quality, a Statewide Network of Access and Quality program composed of five pediatric hematology-oncology organizations throughout Florida. Recognizing the importance of an adequate transition process to minimize morbidity and even mortality among youth with sickle cell disease (SCD), we have worked together for three years in several projects related to transition including educating medical providers and our own practices about SCD, transition, and GotTransition™ Six Core Elements ®. In June 2022, we began a new project with the aim statement that by December 2023, 80% or higher of the sickle cell patients ages 14-21 years attending clinic at the five hematology centers would have a readiness assessment and a transition plan updated at least once during the previous 12 months as assessed on monthly chart audits. At onset, 486 patients met criteria to be on a transition program due to age and cognitive ability. Two programs had previously participated in The Sickle Cell Trevor Thompson Transition Project (ST3P Up) (NCT 03593395), a Patient-Centered Outcomes Research Institute (PCORI) sponsored sickle cell transition study and learned to implement the GotTransition Six Core Elements. Three programs did not have transition programs implemented. The change ideas were either collective or implemented in a particular program depending on the program decision. The collective change ideas consisted of educating the clinical staff about GotTransition and quality improvement strategies, identifying eligible patients through patient roster, and implementing either monthly audits of ten random charts or reviewing charts of all patients who came the previous month for missed opportunities. The program-specific change ideas consisted of prospective review of patients who were scheduled to come to clinic within the week, staff huddles to discuss patients on transition, conversion of paper-based ASH or TIP-RFT sickle cell readiness assessment into electronic medical record (EMR) version, the use of smart phrases to document the readiness assessment and plan, and sharing ownership of the process with different members of the staff for sustainability. Data and learning from improvement strategies were reviewed twice a month with all group members in virtual one-hour meetings. Two quality improvement consultants encouraged and coached sites. Figures show the run charts of the aggregate data. Per the Health Care Data Guide [Provost and Murray vbk://9781119690122] we used the median of the first three data points as a surrogate baseline in the absence of not having any prior data. We froze and extended the baseline median, looked at data collected after the changes were made and adjusted the median once improvement signals emerged. At the aggregate level, the mean percentage with a readiness assessment increased from 50% in June 2022 to 80% in May 2023 and the median performance throughout the 12 months increased from 50% to 81%. The mean percentage with a transition plan increased from 36% in June 2022 to 80% in May 2023 with an increase in the median performance across the 12 months from 36% to 78%. The activities which were identified as most successful were planning ahead of time to assess patients, having electronic document versions of the readiness assessments and documenting plans with smart phrases on the EMRs. Our network was successful in working together, sharing knowledge, and achieving goals. We plan to assess patient reported outcomes such as patient satisfaction with transition and completion of transition process as future projects.

Derivation of paediatric blood pressure percentiles from electronic health records

Identification of abnormal blood pressure (BP) in children requires normative data. We sought to examine the feasibility of using "real-world" office BP data obtained from electronic health records (EHR) to generate age-, sex- and height-specific BP percentiles for children. Using data collected 01/01/2009-8/31/2021 from eight large children's healthcare organisations in PEDSnet, we applied a mixed-effects polynomial regression model with random slopes to generate Z-scores and BP percentiles and compared them with currently used normative BP distributions published in the 2017 American Academy of Paediatrics (AAP) Clinical Practise Guidelines (CPG). We identified a study sample of 292,412 children (1,085,083 BP measurements), ages 3-17 years (53% female), with no chronic medical conditions, who were not overweight/obese and who were primarily seen for general paediatric care in outpatient settings. Approximately 45,000-75,000 children contributed data to each age category. The PEDSnet systolic BP percentile values were 1-4mmHg higher than AAP CPG BP values across age-sex-height groups, with larger differences observed in younger children. Diastolic BP values were also higher in younger children; starting with age 7 years, diastolic BP percentile values were 1-3mmHg lower than AAP CPG values. Cohen's Kappa was 0.90 for systolic BP, 0.66 for diastolic BP, and 0.80 overall indicating excellent agreement between PEDSnet and 2017 AAP CPG data for systolic BP and substantial agreement for diastolic BP. Our analysis indicates that real-word EHR data can be used to generate BP percentiles consistent with current clinical practise on BP management in children. Funding for this work was provided by the Preserving Kidney Function in Children with Chronic Kidney Disease (PRESERVE) study; Patient-Centred Outcomes Research Institute (PCORI) RD-2020C2020338 (Principal Investigator: Dr. Forrest; Co-Principal Investigator: Dr. Denburg).

Avenues for Strengthening PCORnet's Capacity to Advance Patient-Centered Economic Outcomes in Patient-Centered Outcomes Research (PCOR).

PCORnet, the National Patient-Centered Clinical Research Network, provides the ability to conduct prospective and observational pragmatic research by leveraging standardized, curated electronic health records data together with patient and stakeholder engagement. PCORnet is funded by the Patient-Centered Outcomes Research Institute (PCORI) and is composed of 8 Clinical Research Networks that incorporate at total of 79 health system "sites." As the network developed, linkage to commercial health plans, federal insurance claims, disease registries, and other data resources demonstrated the value in extending the networks infrastructure to provide a more complete representation of patient's health and lived experiences. Initially, PCORnet studies avoided direct economic comparative effectiveness as a topic. However, PCORI's authorizing law was amended in 2019 to allow studies to incorporate patient-centered economic outcomes in primary research aims. With PCORI's expanded scope and PCORnet's phase 3 beginning in January 2022, there are opportunities to strengthen the network's ability to support economic patient-centered outcomes research. This commentary will discuss approaches that have been incorporated to date by the network and point to opportunities for the network to incorporate economic variables for analysis, informed by patient and stakeholder perspectives. Topics addressed include: (1) data linkage infrastructure; (2) commercial health plan partnerships; (3) Medicare and Medicaid linkage; (4) health system billing-based benchmarking; (5) area-level measures; (6) individual-level measures; (7) pharmacy benefits and retail pharmacy data; and (8) the importance of transparency and engagement while addressing the biases inherent in linking real-world data sources.

Integrating Care Coordination and Mental Health Research Into Dialysis Practice: Stakeholder Perspectives, Methods, and Outcomes

Despite many studies suggesting beneficial innovations for patients, few make it into clinical practice. This study aims to enhance patient care by facilitating effective dissemination of patient-centered outcomes research to health care workers in outpatient dialysis facilities, aided by the Patient-Centered Outcomes Research Institute's (PCORI) dissemination and implementation framework. Dissemination and implementation project. Outpatient hemodialysis facilities in the United States. We brought together panels of key stakeholders, which included researchers, patient subject matter experts, and dialysis personnel. Their role was to provide guidance on the content and methods for disseminating research findings. With a focus on 2 critical patient safety areas-care coordination or care transitions and mental or behavioral health-we developed virtual education modules. These modules were then made available to outpatient dialysis facilities by the national 5-Diamond Patient Safety Program. In 2022, the training was used by more than 2,500 dialysis facilities and approximately 40,000 dialysis staff in the care coordination module, and by more than 300 dialysis facilities and 5,000 staff for the mental health module. Cumulatively, the modules affected more than 179,000 patients. Evidence of efficacy was the significant increase in trainee knowledge of research findings and implementation considerations (P≤0.05). Potential selection bias because dialysis facilities that did not participate in the program may differ significantly from those that did, which may affect generalizability. In addition, variable timing in release of the different modules may have influenced uptake by facilities. By using key stakeholder guidance and accessible virtual education modules, the implementation framework shows promise in effectively disseminating research findings within outpatient dialysis settings. This method potentially carries implications for broader health care settings as well. Our study addresses a common health care challenge-many promising ideas for improving patient care never actually reach the patients. We aimed to bridge the dissemination gap by sharing research with health care workers in outpatient dialysis, promoting evidence-based practice. We collaborated with experts, patients, and dialysis personnel to develop easy-to-understand educational materials focused on 2 critical topics: care coordination and mental health. In 2022, our training benefited more than 2,500 facilities and 40,000 staff for care coordination, and 300 facilities with 5,000 staff for mental health, positively affecting more than 179,000 patients. We found that the training significantly increased knowledge among staff. Our approach shows promise for sharing research effectively in dialysis centers and potentially in other health care settings.

Assessment of racial and ethnic inequities in copay card utilization and enrollment in copay adjustment programs.

BACKGROUND: Increases in consumer cost sharing lead to decreases in the use of both high- and low-value care. Copay assistance was designed to reduce out-of-pocket (OOP) cost burden. Commercial insurers have recently instituted copay adjustment programs (CAPs), which exclude copay assistance from deductibles and OOP cost maximums, thereby effectively increasing the financial burden on patients. The utilization of these programs by specific demographic populations is unknown. OBJECTIVE: To assess utilization of copay assistance and CAP exposure in a commercially insured patient population and examine potential differences in the use of each of these programs by non-White and by White patients. METHODS: A retrospective, cross-sectional study using IQVIA Longitudinal Access and Adjudication Data, linked to Experian Marketing Solutions, LLC consumer data, identified unique patients who were younger than 65 years, covered by commercial insurance, had at least 1 pharmacy claim for treatment within prespecified therapeutic areas, and had full financial data visibility on paid claims (ie, nonmissing data on costs associated with the pharmacy claim and the secondary payer) between January 1, 2019, and September 30, 2021. Analyses of copay card use or CAP exposure (defined as the likelihood to be included in the accumulator or maximizer program) between non-White and White patient populations were adjusted for age, gender, household income, patient state of residence, pharmacy benefit manager, state-level CAP policy, and overall drug cost. RESULTS: In total, 4,073,599 unique patients (5.6% of the total database population) were included in the copay card analysis. In adjusted analyses, there were no significant differences in copay card utilization between non-White patients and White patients (odds ratio [OR] = 0.995, 95% CI = 0.99-1.00; P = 0.0964). However, among copay card users, non-White patients were significantly more likely to be exposed to CAPs, as either maximizers (OR = 1.27, 95% CI = 1.22-1.33; P < 0.0001) or accumulators (OR = 1.31, 95% CI = 1.26-1.36; P < 0.0001), compared with White patients. CONCLUSIONS: In an adjusted analysis of this selected sample of a commercially insured population, there was no difference in the use of copay cards between non-White and White patients. CAP exposure, however, was significantly higher among non-White patients. This increased exposure suggests a disproportionate effect due to this reduction in copay assistance benefits, which has the potential to exacerbate racial and ethnic disparities in access to medications. DISCLOSURES: This study was sponsored by Janssen Scientific Affairs, LLC. Mr Ingham, Dr Sadik, and Dr Song are employees of Janssen Scientific Affairs, LLC. Dr Zhao is an employee of IQVIA. Dr Fendrick is a consultant for AbbVie, Amgen, Bayer, CareFirst BlueCross BlueShield, Centivo, Community Oncology Association, Covered California, EmblemHealth, Exact Sciences, Freedman Health, GRAIL, Harvard University, Health & Wellness Innovations, Health at Scale Technologies, HealthCorum, Hygeia, MedsIncontext, MedZed, Merck, Mercer, Montana Health Cooperative, Pair Team, Penguin Pay, Phathom Pharmaceuticals, Proton Intelligence, Risalto Health, Risk International, Sempre Health, Silver Fern Health, State of Minnesota, Teladoc Health, US Department of Defense, Virginia Center for Health Innovation, Wellth, Wildflower Health, Yale New Haven Health System, and Zansors; received research funds from Agency for Healthcare Research and Quality (AHRQ), Boehringer-Ingelheim, Gary and Mary West Health Policy Center, Arnold Ventures, National Pharmaceutical Council, Patient-Centered Outcomes Research Institute (PCORI), Pharmaceutical Research and Manufacturers of America (PhRMA), Robert Wood Johnson (RWJ) Foundation, State of Michigan/The Centers for Medicare & Medicaid Services (CMS); and has an outside position at the American Journal of Managed Care (AJMC; co-editor), Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) member, VBID Health (partner).

189-LB: LDL Cholesterol Reduction and Cardiovascular Outcomes in High-Risk Primary Prevention Patients

Background: Current guidelines recommend reducing LDL cholesterol in patients at high risk for a first major adverse cardiovascular event (primary prevention). However, these recommendations are predominately based on clinical trials conducted many years ago. Most contemporary trials of LDL-cholesterol lowering therapies have enrolled only secondary prevention patients. Some authorities have questioned whether the benefits of cholesterol lowering exceed the harms in primary prevention patients. Currently, lipid-lowering therapies are underutilized in high-risk patients without a prior event, particularly in women and patients with diabetes. More than half of eligible patients are not currently receiving LDL-cholesterol lowering therapies. Methods: The CLEAR Outcomes trial reported cardiovascular outcomes for bempedoic acid treatment compared with placebo in a mixed population of primary and secondary prevention patients unable or unwilling to take guideline-recommended doses of statins (N=13,970). The primary end point was a composite of death from cardiovascular causes, nonfatal myocardial infarction (MI), nonfatal stroke, or coronary revascularization. The results of the CLEAR OUTCOMES trial were presented and simultaneously published in the NEJM on March 4. The hazard ratio for the primary end point for the full population was 0.87 (95% CI 0.79-0.96), P=0.004. Results: In the CLEAR Outcomes trial, 4206 patients (30%) met high risk primary prevention entry criteria, two thirds with diabetes. The HR in these primary prevention patients was lower than the HR for secondary prevention patients, 0.68 (95% CI 0.53-0.87), with a significant interaction P value (0.03). The current Late Breaking Trial will report detailed results for the primary and all key secondary endpoints for the 4206 patients enrolled based on high risk primary prevention criteria. Full results will be available in mid-April for simultaneous presentation and publication during the ADA meeting. Disclosure S. Nissen: Research Support; Eli Lilly and Company, AbbVie Inc., AstraZeneca, Bristol-Myers Squibb Company, ESPERION Therapeutics, Inc., New Amsterdam Pharma, Novartis, Patient-Centered Outcomes Research Institute, Silence Therapeutics. For the clear outcomes trial investigators: n/a. Funding National Heart, Lung, and Blood Institute (K23HL153774 to J.E.T.); University of Toronto (to B.R.S.)

Risk of new disease activity in patients with multiple sclerosis who continue or discontinue disease-modifying therapies (DISCOMS): a multicentre, randomised, single-blind, phase 4, non-inferiority trial

Multiple sclerosis typically has onset in young adults and new disease activity diminishes with age. Most clinical trials of disease-modifying therapies for multiple sclerosis have not enrolled individuals older than 55 years. Observational studies suggest that risk of return of disease activity after discontinuation of a disease-modifying therapies is greatest in younger patients with recent relapses or MRI activity. We aimed to determine whether risk of disease recurrence in older patients with no recent disease activity who discontinue disease-modifying therapy is increased compared to those who remain on disease-modifying therapy. DISCOMS was a multicentre, randomised, controlled, rater-blinded, phase 4, non-inferiority trial. Individuals with multiple sclerosis of any subtype, 55 years or older, with no relapse within the past 5 years or new MRI lesion in the past 3 years while continuously taking an approved disease-modifying therapy were enrolled at 19 multiple sclerosis centres in the USA. Participants were randomly assigned (1:1 by site) with an interactive response technology system to either continue or discontinue disease-modifying therapy. Relapse assessors and MRI readers were masked to patient assignment; patients and treating investigators were not masked. The primary outcome was percentage of individuals with a new disease event, defined as a multiple sclerosis relapse or a new or expanding T2 brain MRI lesion, over 2 years. We assessed whether discontinuation of disease-modifying therapy was non-inferior to continuation using a non-inferiority, intention-to-treat analysis of all randomly assigned patients, with a predefined non-inferiority margin of 8%. This trial is registered at ClinicalTrials.gov, NCT03073603, and is completed. 259 participants were enrolled between May 22, 2017, and Feb 3, 2020; 128 (49%) were assigned to the continue group and 131 (51%) to the discontinue group. Five participants were lost to follow-up (continue n=1, discontinue n=4). Six (4·7%) of 128 participants in the continue group and 16 (12·2%) of 131 in the discontinue group had a relapse or a new or expanding brain MRI lesion within 2 years. The difference in event rates was 7·5 percentage points (95% CI 0·6-15·0). Similar numbers of participants had adverse events (109 [85%] of 128 vs 104 [79%] of 131) and serious adverse events (20 [16%] vs 18 [14%]), but more adverse events (422 vs 347) and serious adverse events (40 vs 30) occurred in the discontinue group. The most common adverse events were upper respiratory infections (20 events in 19 [15%] participants in the continue group and 37 events in 30 [23%] participants in the discontinue group). Three participants in the continue group and four in the discontinue group had treatment-related adverse events, of which one in each group was a serious adverse event (multiple sclerosis relapse requiring admission to hospital). One participant in the continue group and two in the discontinue group died; no deaths were deemed to be related to treatment. We were unable to reject the null hypothesis and could not conclude whether disease-modifying therapy discontinuation is non-inferior to continuation in patients older than 55 years with multiple sclerosis and no recent relapse or new MRI activity. Discontinuation of disease-modifying therapy might be a reasonable option in patients older than 55 years who have stable multiple sclerosis, but might be associated with a small increased risk of new MRI activity. Patient-Centered Outcomes Research Institute and the National Multiple Sclerosis Society.

1031-P: Virtual Clinic Support—Patient-Reported Outcome Benefits

Behavioral health support can benefit those living with diabetes, but there is limited information on patient reported outcomes (PROs) associated with a virtual clinic. Adults with diabetes (n=234) received virtual care including support for CGM initiation and management over a 6-month study period. Care was led by a CDCES with support from a behavioral team. Participants completed PROs surveys 1) at baseline and 6 months to evaluate change and 2) each month on diabetes distress (DD), fear of hypoglycemia (FOH), and depression (DEP). Full list of PROs surveys included in table. A positive screen led to recommendation for a brief behavioral intervention. Participants with T1D (n=160) were 44(±14) years and mean baseline A1c of 7.8%. Participants with T2D (n=74) were 55(±12) years and mean baseline A1c of 8.1%. Participants screened positive for DD, FOH, or DEP 67% of the time with FOH as the most common concern. Of those with a positive screen, 70% of T1D and 59% of T2D participants had at least one behavioral team contact. Virtual clinic care was associated with a benefit on 7 of 9 PROs for T1D and 7 of 9 PROs for T2D (p values &amp;lt; 0.05; see table). For these virtual clinic adults with diabetes, PROs improved 78% of the time with noteworthy benefits of less FOH, less DD, and more glucose monitoring satisfaction. Paired with the glycemic improvements observed in this virtual clinic study, there were robust benefits on the quality of life of adults with diabetes. Disclosure K.K.Hood: Consultant; Cecelia Health. S.Oser: Advisory Panel; Cecelia Health, Dexcom, Inc., Consultant; Medscape, Research Support; Abbott Diabetes. T.Oser: Advisory Panel; Cecelia Health, Consultant; Dexcom, Inc., Medscape, Research Support; Abbott. D.Raghinaru: None. Z.Thompson: None. R.S.Weinstock: Consultant; Jaeb Center for Health Research, Other Relationship; Wolters Kluwer Health, Research Support; Insulet Corporation, Medtronic, Eli Lilly and Company, Novo Nordisk, Boehringer Ingelheim Inc., Hemsley Charitable Trust, National Institute of Diabetes and Digestive and Kidney Diseases, Tandem Diabetes Care, Inc., Kowa Pharmaceuticals America, Inc. R.Beck: Consultant; Eli Lilly and Company, Novo Nordisk, Diasome, Insulet Corporation, Research Support; Tandem Diabetes Care, Inc., Beta Bionics, Inc., Dexcom, Inc., Bigfoot Biomedical, Inc., Medtronic, Ascensia Diabetes Care, Roche Diabetes Care, Eli Lilly and Company, Novo Nordisk. G.Aleppo: Advisory Panel; Medscape, Consultant; Bayer Inc., Insulet Corporation, Research Support; Dexcom, Inc., Eli Lilly and Company, Emmes, Insulet Corporation, Fractyl Health, Inc., WellDoc, Speaker's Bureau; Dexcom, Inc. R.M.Bergenstal: Advisory Panel; Abbott Diabetes, Eli Lilly and Company, Medtronic, Novo Nordisk, Roche Diabetes Care, Zealand Pharma A/S, Consultant; Ascensia Diabetes Care, Bigfoot Biomedical, Inc., CeQur SA, Dexcom, Inc., Hygieia, Onduo LLC, Sanofi, Vertex Pharmaceuticals Incorporated, Research Support; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk, Sanofi, UnitedHealth Group. T.L.Cushman: None. R.L.Gal: None. C.Kollman: Research Support; Insulet Corporation, Dexcom, Inc., Tandem Diabetes Care, Inc. D.F.Kruger: Advisory Panel; Abbott Diabetes, Lilly, Medtronic, Novo Nordisk, Research Support; Dexcom, Inc., Beta Bionics, Inc., Speaker's Bureau; Dexcom, Inc., Lilly, Xeris Pharmaceuticals, Inc., Novo Nordisk. M.L.Johnson: Research Support; Abbott, Lilly, Insulet Corporation, NIH - National Institutes of Health, Patient-Centered Outcomes Research Institute, Novo Nordisk, Tandem Diabetes Care, Inc., Medtronic, Hemsley Charitable Trust, Jaeb Center for Health Research. T.S.Mcarthur: None. B.A.Olson: Stock/Shareholder; Abbott. Funding The Leona M. and Harry B. Helmsley Charitable Trust; Dexcom, Inc.

1174-P: Characterization of Glucose Levels in Pregnancy Measured by Blood Glucose Testing or CGM Monitoring after a 50-g Screening or a 75-g or 100-g OGTT

Glucose challenge testing (GCT) is standard diagnostic approach for gestational diabetes (GDM). Using CGM glucose values to characterize glycemia during GCT is not well described. CGM and blood glucose (BG) values were matched with closest CGM value ±5 min of each reported BG time. GDM diagnosed by standard glucose thresholds for 50g GCT, 75g and 100g OGTTs. GCT (n=543, mean gestation 28 wks) showed mean±SD 1 hr BG of 117±28 mg/dL, while matched CGM mean BG was 126±36 mg/dL. The 1 hr BG was ≥135 mg/dL in 24% of GCT vs. 38% by CGM. OGTT (75g) (n=44, mean gestational age 28 wks) showed mean±SD fasting, 1 hr and 2 hr BG of 84±9 mg/dL, 156±33 mg/dL, and 119±26 mg/dL. OGTT (100g) (n=77, mean gestational age 29 wks) showed mean±SD fasting, 1 hr, 2 hr, and 3 hr BG of 82±9 mg/dL, 166±31 mg/dL, 137±27, and 101±27 mg/dL. CGM levels during GCT and both OGTT were similar but slightly higher for each time point; maximum glucose and glucose excursions were also similar between each test vs CGM. Those diagnosed with GDM had consistently higher CGM glucoses than those without GDM (Figure 1). CGM during GCT/OGTT demonstrates CGM correlates to BG, although consistently slightly higher for all 3 glucose tests, regardless of glucose load or timing of measurement. Correlating CGM values to obstetric outcomes would help further describe the role of CGM for diagnosing GDM and improving glucose metabolism in pregnancy. Disclosure A.L.Carlson: Advisory Panel; MannKind Corporation, Novo Nordisk, Research Support; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Medtronic, Novo Nordisk, Insulet Corporation, UnitedHealth Group, Sanofi. J.Sibayan: None. P.Calhoun: None. C.Durnwald: None. R.Beck: Consultant; Eli Lilly and Company, Novo Nordisk, Diasome, Insulet Corporation, Research Support; Tandem Diabetes Care, Inc., Beta Bionics, Inc., Dexcom, Inc., Bigfoot Biomedical, Inc., Medtronic, Ascensia Diabetes Care, Roche Diabetes Care, Eli Lilly and Company, Novo Nordisk. Z.Li: None. E.Norton: None. R.M.Bergenstal: Advisory Panel; Abbott Diabetes, Eli Lilly and Company, Medtronic, Novo Nordisk, Roche Diabetes Care, Zealand Pharma A/S, Consultant; Ascensia Diabetes Care, Bigfoot Biomedical, Inc., CeQur SA, Dexcom, Inc., Hygieia, Onduo LLC, Sanofi, Vertex Pharmaceuticals Incorporated, Research Support; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk, Sanofi, UnitedHealth Group. M.L.Johnson: Research Support; Abbott, Lilly, Insulet Corporation, NIH - National Institutes of Health, Patient-Centered Outcomes Research Institute, Novo Nordisk, Tandem Diabetes Care, Inc., Medtronic, Hemsley Charitable Trust, Jaeb Center for Health Research. S.Dunnigan: None. M.Banfield: None. K.J.Krumwiede: None. Funding The Leona M. and Harry B. Helmsley Charitable Trust; United Health Group

173-OR: CGM-Measured Differences in Pregnancies With vs. Without Gestational Diabetes (GDM) and Adverse Perinatal Outcomes (APO)

An objective of the study was to characterize if continuous glucose monitor (CGM) glycemic patterns throughout pregnancy are indicative of gestational diabetes (GDM) and adverse pregnancy outcomes (APOs). A prospective observational cohort of 760 pregnant patients enrolled &amp;lt;17 weeks with A1c &amp;lt;6.5% wore a blinded CGM sequentially during pregnancy. Patients with ≥14 days of CGM data overall with ≥10 days in the 2nd trimester, oral glucose tolerance test (OGTT), and an APO assessment were included. The primary outcome was GDM diagnosis by abnormal OGTT. Large gestational age (LGA) birthweight &amp;gt;90% and hypertensive disorder of pregnancy (HDP) were analyzed. Glycemic metrics using CGM between those with and without GDM and each APO were compared. Participants had a mean±SD of 112±42 days of CGM data. Prevalence of GDM, LGA, and HDP were 7%, 16%, and 27%. Mean glucose, glucose standard deviation, time &amp;gt; 120 mg/dL and &amp;gt; 140 mg/dL were significantly higher during the entire gestational period prior to OGTT (mean 27 ± 2 weeks) in those who developed GDM. TIR 63-120 mg/dL and 63-140 mg/dL were significantly lower in those who developed GDM (Table 1). Similar findings were noted for the diagnosis of LGA and HDP. CGM use during pregnancy revealed glycemic differences between those with vs without GDM, LGA, and HDP throughout gestation. Higher glucose levels during pregnancy are associated with these APOs. Disclosure C.Durnwald: None. P.Calhoun: None. A.L.Carlson: Advisory Panel; MannKind Corporation, Novo Nordisk, Research Support; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Medtronic, Novo Nordisk, Insulet Corporation, UnitedHealth Group, Sanofi. R.Beck: Consultant; Eli Lilly and Company, Novo Nordisk, Diasome, Insulet Corporation, Research Support; Tandem Diabetes Care, Inc., Beta Bionics, Inc., Dexcom, Inc., Bigfoot Biomedical, Inc., Medtronic, Ascensia Diabetes Care, Roche Diabetes Care, Eli Lilly and Company, Novo Nordisk. Z.Li: None. E.Norton: None. R.M.Bergenstal: Advisory Panel; Abbott Diabetes, Eli Lilly and Company, Medtronic, Novo Nordisk, Roche Diabetes Care, Zealand Pharma A/S, Consultant; Ascensia Diabetes Care, Bigfoot Biomedical, Inc., CeQur SA, Dexcom, Inc., Hygieia, Onduo LLC, Sanofi, Vertex Pharmaceuticals Incorporated, Research Support; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk, Sanofi, UnitedHealth Group. M.Banfield: None. M.L.Johnson: Research Support; Abbott, Lilly, Insulet Corporation, NIH - National Institutes of Health, Patient-Centered Outcomes Research Institute, Novo Nordisk, Tandem Diabetes Care, Inc., Medtronic, Hemsley Charitable Trust, Jaeb Center for Health Research. S.Dunnigan: None. J.Sibayan: None. Funding The Leona M. and Harry B. Helmsley Charitable Trust; United Health Group