Disparities in Diagnosis, Treatment, and Outcomes of Peripheral Artery Disease: JACC Scientific Statement.

Disparities by sex, race, socioeconomic status, and geography exist in diagnosis, treatment, and outcomes for people with lower extremity peripheral artery disease (PAD). PAD prevalence is similar in men and women, but women have more atypical symptoms and undergo lower extremity revascularization at older ages compared to men. People who are Black have an approximately 2-fold higher prevalence of PAD, compared to people who are White and have more atypical symptoms, greater mobility loss, less optimal medical care, and higher amputation rates. Although fewer data are available for other races, people with PAD who are Hispanic have higher amputation rates than White people. Rates of amputation also vary by geography in the United States, with the highest rates of amputation in the southeastern United States. To improve PAD outcomes, intentional actions to eliminate disparities are necessary, including clinician education, patient education with culturally appropriate messaging, improved access to high-quality health care, science focused on disparity elimination, and health policy changes.

Engaging Operational Partners Is Critical for Successful Implementation of Research Products: a Coincidence Analysis of Access-Related Projects in the Veterans Affairs Healthcare System.

BACKGROUND/OBJECTIVE: The Veterans Health Administration (VHA) has prioritized timely access to care and has invested substantially in research aimed at optimizing veteran access. However, implementing research into practice remains challenging. Here, we assessed the implementation status of recent VHA access-related research projects and explored factors associated with successful implementation. DESIGN: We conducted a portfolio review of recent VHA-funded or supported projects (1/2015-7/2020) focused on healthcare access ("Access Portfolio"). We then identified projects with implementable research deliverables by excluding those that (1) were non-research/operational projects; (2) were only recently completed (i.e., completed on or after 1/1/2020, meaning that they were unlikely to have had time to be implemented); and (3) did not propose an implementable deliverable. An electronic survey assessed each project's implementation status and elicited barriers/facilitators to implementing deliverables. Results were analyzed using novel Coincidence Analysis (CNA) methods. PARTICIPANTS/KEY RESULTS: Among 286 Access Portfolio projects, 36 projects led by 32 investigators across 20 VHA facilities were included. Twenty-nine respondents completed the survey for 32 projects (response rate = 88.9%). Twenty-eight percent of projects reported fully implementing project deliverables, 34% reported partially implementing deliverables, and 37% reported not implementing any deliverables (i.e., resulting tool/intervention not implemented into practice). Of 14 possible barriers/facilitators assessed in the survey, two were identified through CNA as "difference-makers" to partial or full implementation of project deliverables: (1) engagement with national VHA operational leadership; (2) support and commitment from local site operational leadership. CONCLUSIONS: These findings empirically highlight the importance of operational leadership engagement for successful implementation of research deliverables. Efforts to strengthen communication and engagement between the research community and VHA local/national operational leaders should be expanded to ensure VHA's investment in research leads to meaningful improvements in veterans' care. The Veterans Health Administration (VHA) has prioritized timely access to care and has invested substantially in research aimed at optimizing veteran access. However, implementing research findings into clinical practice remains challenging, both within and outside VHA. Here, we assessed the implementation status of recent VHA access-related research projects and explored factors associated with successful implementation. Only two factors were identified as "difference-makers" to adoption of project findings into practice: (1) engagement with national VHA leadership or (2) support and commitment from local site leadership. These findings highlight the importance of leadership engagement for successful implementation of research findings. Efforts to strengthen communication and engagement between the research community and VHA local/national leaders should be expanded to ensure VHA's investment in research leads to meaningful improvements in veterans' care.

Dissemination of an evidence-based behavioral intervention to alleviate distress in caregivers of children recently diagnosed with cancer: Bright IDEAS.

BACKGROUND: Four multisite randomized clinical trials of > 1400 caregivers of children newly diagnosed with cancer showed that the Bright IDEAS (BI) paradigm of problem-solving skills training is an acceptable and efficacious approach to alleviating the high levels of distress they experience. To facilitate providing evidence-based caregiver support as recommended in the pediatric oncology standards of care, the project described here was designed to disseminate BI to 200 psychosocial professionals. PROCEDURE: We partnered with the Children's Oncology Group (COG), Association of Pediatric Oncology Social Workers (APOSW), Association of Pediatric Hematology/Oncology Nurses (APHON), and special interest group in pediatric hematology/oncology of the Society for Pediatric Psychology (SPP). Membership surveys revealed substantial enthusiasm for training in BI. We structured training to include review of the evidence base for BI, role plays, and strategies for implementation at individual sites. Four conference calls designed to enhance implementation were held one, two, three, and five months after training. RESULTS: Ten 1.5-day workshops were held in conjunction with annual meetings of COG, APOSW, APHON, and SPP. A total of 209 psychosocial clinicians from 134 sites were trained. Evaluations were highly favorable. Trainees had provided BI to 545 individuals as of the last conference call. CONCLUSIONS: Initial dissemination goals were met. BI is now available at numerous pediatric oncology centers, but it has not become part of routine care. Future work focused on implementation might consider top-down approaches that include direct communication with pediatric oncologists and hospital leaders about the benefits of incorporating this evidence-based intervention systemically.

Engaging Stakeholders in Identifying Access Research Priorities for the Department of Veterans Affairs.

BACKGROUND: The Veterans Access Research Consortium (VARC), a Department of Veterans Affairs (VA) Consortium of Research focused on access to healthcare, has been funded by VA's Health Services Research and Development Service (HSR&D) to develop a research roadmap for healthcare access. The goal of the roadmap is to identify operationally aligned research questions that are most likely to lead to meaningful improvements in Veterans' healthcare access. OBJECTIVES: To describe the process of soliciting diverse stakeholder perspectives about key priorities on which VA's HSR&D access agenda should focus and identify the results of that process. METHODS: We used a modified Delphi approach to engage researchers and VA operational partners in a process to develop recommendations regarding the access-related research questions VA should prioritize. We then collaborated with three Veteran Engagement Groups (VEGs) across the country to solicit Veterans' reactions to the Delphi results and their perspectives about access-related issues affecting access to VA health care. RESULTS: The Delphi panel consisted of 22 research and operational experts, both internal and external to VA. The Delphi process resulted in five research questions identified by the panelists as highest priority for VA to pursue, each representing one of the following domains: (1) measurement of access, (2) barriers to access, (3) equity and subpopulations, (4) effective interventions to improve access, and (5) consequences of poor/better access. Veterans' perspectives focused primarily on the barriers to access domain. Veterans indicated several barriers that might be addressed through research or operational initiatives, including poor communication about services, weak connections to and partnerships with local community care facilities, and poor provision of telehealth resources and education. CONCLUSIONS: Engaging multiple methods to solicit stakeholder perspectives enables more nuanced understanding of access-related priorities for VA. Future research should consider utilizing such an approach to identify additional research and/or operational priorities.

Operational and Ethical Considerations for a National Adult Congenital Heart Disease Database.

As more adults survive with congenital heart disease, the need to better understand the long-term complications, and comorbid disease will become increasingly important. Improved care and survival into the early and late adult years for all patients equitably requires accurate, timely, and comprehensive data to support research and quality-based initiatives. National data collection in adult congenital heart disease will require a sound foundation emphasizing core ethical principles that acknowledge patient and clinician perspectives and promote national collaboration. In this document we examine these foundational principles and offer suggestions for developing an ethically responsible and inclusive framework for national ACHD data collection.

Core functions and forms of Bright IDEAS: A multi-methods evaluation of the adoption of an evidence-based psychosocial training program through iterative adaptation.

Background: Despite efforts to widely disseminate interventions designed to increase access to quality supportive care to pediatric cancer patients and their families, many of these interventions fail to meet expectations once deployed in real-life clinical settings. This study identifies the functions and forms of Bright IDEAS: Problem-Solving Skills Training, an evidence based psychosocial intervention for caregivers of children recently diagnosed with cancer, to identify pragmatic program adaptations in its real-world clinical implementation. We compare intervention adoption before and after adaptations to the Bright IDEAS training program as part of a national training program designed to disseminate the intervention. Methods: 209 pediatric psychosocial oncology practitioners representing 134 unique institutions were trained during 10 in-person 8-hour workshops (2015-2019). Functions and forms of Bright IDEAS were identified, and adaptations made to the training agenda and curriculum based on practitioner feedback following implementation in local institutions. Mixed method evaluation included longitudinal surveys at 6- and 12-months post training; and qualitative interviews among a subgroup of practitioners (N = 47) to understand and compare perspectives on intervention adoption and barriers to implementation before and after adaptations to the Bright IDEAS training program. The RE-AIM framework was used to guide dissemination evaluation. Results: A total of four adaptations were tailored to the identified forms of the intervention: case studies; pre-training reading materials; training videos; and letters of institutional support from primary supervisor. Pre- and post-training adaptations to the Bright IDEAS training program were mapped to RE-AIM constructs. Quantitative findings demonstrate that adaptations appeared to improve adoption and usage overall. Conclusion: This study provides insight into how contextual factors influence psychosocial practitioners' capacity to adopt, implement, and maintain Bright IDEAS in the clinical setting. This study demonstrates the use of real-time stakeholder feedback to guide intervention translation from research to practice settings.

Promoting rigor and sustainment in implementation science capacity building programs: A multi-method study.

Background: The field of Implementation science (IS) continues to evolve, and the number and type of IS capacity building Programs (ISCBPs) are in flux. These changes push the field to revisit the accepted IS competencies and to guide sustainment of ISCBPs. Our objectives were: (1) compare characteristics of current ISCBPs; (2) identify recommendations to support ISCBP sustainment; (3) measure how often ISCBPs address IS competencies; (4) identify novel and important IS competencies for the field. Method: This multi-method study included ISCBPs delivering structured, longitudinal IS training, excluding single courses and brief workshops. We used three complementary methods to meet our objectives. First, we identified ISCBPs via an internet search and snowball sampling methods. Second, we surveyed these ISCBPs to identify areas of program focus, types of trainees, IS competencies addressed, and recommendations to sustain ISCBPs. Third, we conducted a modified Delphi process with IS researchers/leaders to reach consensus on the IS competencies that were both important and novel as compared to the IS competencies published to date. Results: Among 74 eligible ISCBPs identified, 46 responded (62% response rate). Respondent ISCBPs represented diverse areas of focus (e.g., global health, cardiopulmonary disease) and trainee stages (e.g., graduate students, mid-career faculty). While most respondent ISCBPs addressed core IS methods, targeting IS competencies was less consistent (33% for nongraduate/non-fellowship ISCBPs; >90% for graduate/national ISCBPs). Our modified Delphi process identified eight novel and important IS competencies related to increasing health equity or the speed of translation. Recommendations to sustain ISCBPs included securing financial administrative support. Conclusions: Current ISCBPs train learners across varying career stages in diverse focus areas. To promote rigor, we recommend ISCBPs address specific IS competencies, with consideration of these eight novel/emerging competencies. We also recommend ISCBPs report on their IS competencies, focus area(s), and trainee characteristics. ISCBP programs need administrative financial support. Plain Language Summary: There is a limited workforce capacity to conduct implementation science (IS) research. To address this gap, the number and type of IS capacity building Programs (ISCBPs) focusing on training researchers and practitioners in IS methods continue to increase. Our efforts to comprehensively identify and describe ISCBPs for researchers and practitioners highlighted four implications for leaders of ISCBPs related to program sustainment and rigor. First, we identified a range of contextual characteristics of ISCBPs, including the research topics, methods, and IS competencies addressed, and the types of trainees accepted. Second, given the variability of trainee types and research, rigorous ISCBP programs should tailor the IS competencies and methods addressed to the skills needed by the types of trainees in their program. Third, the field of IS needs to periodically revisit the competencies needed with attention to the skills needed in the field. We used a consensus-building process with ISCBP leaders and other IS experts to expand existing IS competencies and identified eight important, novel IS competencies that broadly relate to promoting health equity and speeding the translation of research to practice. Finally, as more institutions consider developing ISCBPs, we identified factors needed to support ISCBP sustainment, including ongoing financial support. In addition to these implications for ISCBP leaders, there are also policy implications. For example, IS journals may enact policies to require manuscripts evaluating ISCBP performance to report on certain contextual characteristics, such as the IS competencies addressed and types of trainees accepted. The field may also consider developing an accreditation body to evaluate the rigor of ISCBP curricula.

Fostering innovation at Academic Medical Centers: The Case of University of Colorado Anschutz Medical Campus.

Commercializing biomedical discoveries is a challenging process for many reasons. However, Academic Medical Centers (AMC) that have teaching, patient care, research, and service engrained in their mission are well poised to host these discoveries. These academic discoveries can lead to improvement in patient health and economic development if supported to cross the "valley of death" through institutional assistance, by providing guidance, gap funding and product development expertise. Colorado has a vibrant local startup ecosystem, state support for commercialization and entrepreneurship as well as critical mass of product development expertise. University of Colorado Anschutz Medical Campus, as a major AMC, is an engine for growth for the region. This article discusses innovation efforts at the University of Colorado Anschutz Medical Campus as a case study, which is built around two major efforts: the CCTSI and CU Innovations. I-Corps at CCTSI and the SPARK|REACH program of CU Innovations have been instrumental in fostering innovation, commercialization, and entrepreneurship on the campus.

Potential unrealized mortality benefit of glucagon-like peptide-1 receptor agonists and sodium-glucose co-transport-2 inhibitors: A report from the Veterans Health Administration Clinical Assessment, Reporting and Tracking program.

AIM: To assess the unrealized potential of glucagon-like peptide-1 receptor agonist (GLP-1RA) or sodium-glucose co-transport-2 inhibitor (SGLT2i) use to reduce mortality in veterans with type 2 diabetes (T2D), coronary artery disease (CAD), and other characteristics congruent with clinical trial cohorts that established the efficacy of these agents. METHODS: Veterans with T2D and CAD on angiography in 2014 who were untreated with either a GLP-1RA or a SGLT2i were assessed for key eligibility criteria of the LEADER (GLP-1RA) and EMPA-REG OUTCOME (SGLT2i) trials. Trial hazard ratios and 95% confidence intervals for all-cause death were applied to deaths observed in veterans through 2018 to estimate the potential benefit of GLP-1RA or SGLT2i use. RESULTS: Median observation was 4.3 years. Of 15 987 veterans with T2D and CAD, 1186 (7.4%) were excluded for GLP-1RA or SGLT2i treatment, and 1386 lacked glycated haemoglobin measurement. Of the remaining 13 415 patients, 4103 (30.1%) and 5313 (39.6%) fulfilled the key criteria for the LEADER and EMPA-REG OUTCOME trials, respectively. Death occurred in 1009 (24.6%) of LEADER-eligible patients and 1335 (25.1%) of EMPA-REG OUTCOME-eligible patients. Under treatment with liraglutide in LEADER-eligible veterans, a 3.5% (0.7%-6.2%) potential absolute mortality reduction, corresponding to 144 (28-253) fewer deaths (0.88 [0.17-1.56] per 100 person-years), might have been expected. Similarly, under treatment with empagliflozin in EMPA-REG OUTCOME-eligible veterans, a 7.9% (4.5%-10.8%) potential absolute mortality reduction, corresponding to 418 (230-573) fewer deaths (1.98 [1.14-2.72] per 100 person-years), might have been expected. CONCLUSIONS: This analysis indicates unrealized opportunities to reduce mortality in selected veterans with T2D and CAD via increased GLP-1RA and SGLT2i use.

Enhancing Success of Medicare's Shared Decision Making Mandates Using Implementation Science: Examples Applying the Pragmatic Robust Implementation and Sustainability Model (PRISM).

The Centers for Medicare and Medicaid Services (CMS) has mandated shared decision making (SDM) using patient decision aids for three conditions (lung cancer screening, atrial fibrillation, and implantable defibrillators). These forward-thinking approaches are in response to a wealth of efficacy data demonstrating that decision aids can improve patient decision making. However, there has been little focus on how to implement these approaches in real-world practice. This article demonstrates how using an implementation science framework may help programs understand multilevel challenges and opportunities to improve adherence to the CMS mandates. Using the PRISM (Pragmatic Robust Implementation and Sustainability Model) framework, we discuss general challenges to implementation of SDM, issues specific to each mandate, and how to plan for, enhance, and assess SDM implementation outcomes. Notably, a theme of this discussion is that successful implementation is context-specific and to truly have successful and sustainable changes in practice, context variability, and adaptation to context must be considered and addressed.

Perspectives of scientists on disseminating research findings to non-research audiences.

BACKGROUND: Little is known about practices used to disseminate findings to non-research, practitioner audiences. This study describes the perspectives, experience and activities of dissemination & implementation (D&I) scientists around disseminating their research findings. METHODS: The study explored D&I scientists' experiences and recommendations for assessment of dissemination activities to non-research audiences. Existing list serves were used to recruit scientists. Respondents were asked three open-ended questions on an Internet survey about dissemination activities, recommendations for changing evaluation systems and suggestions to improve their own dissemination of their work. RESULTS: Surveys were completed by 159 scientists reporting some training, funding and/or publication history in D&I. Three themes emerged across each of the three open-ended questions. Question 1 on evaluation generated the themes of: 1a) promotional review; 1b) funding requirements and 1c) lack of acknowledgement of dissemination activities. Question 2 on recommended changes generated the themes of: 2a) dissemination as a requirement of the academic promotion process; 2b) requirement of dissemination plan and 2c) dissemination metrics. Question 3 on personal changes to improve dissemination generated the themes of: 3a) allocation of resources for dissemination activities; 3b) emerging dissemination channels and 3c) identify and address issues of priority for stakeholders. CONCLUSIONS: Our findings revealed different types of issues D&I scientists encounter when disseminating findings to clinical, public health or policy audiences and their suggestions to improve the process. Future research should consider key requirements which determine academic promotion and grant funding as an opportunity to expand dissemination efforts.

I-Corps@NCATS trains clinical and translational science teams to accelerate translation of research innovations into practice.

INTRODUCTION: A key barrier to translation of biomedical research discoveries is a lack of understanding among scientists regarding the complexity and process of implementation. To address this challenge, the National Science Foundation's Innovation Corps™ (I-Corps™) program trains researchers in entrepreneurship. We report results from the implementation of an I-Corps™ training program aimed at biomedical scientists from institutions funded by the National Center for Advancing Translational Sciences (NCATS). METHODS: National/regional instructors delivered 5-week I-Corps@NCATS short courses to 62 teams (150 individuals) across six institutions. Content included customer discovery, value proposition, and validating needs. Teams interviewed real-life customers and presented the value of innovations for specific end-users weekly, culminating in a "Finale" featuring their refined business thesis and business model canvas. Methodology was developed to evaluate the newly adapted program. National mixed-methods evaluation assessed program implementation, reach, effectiveness using observations of training delivery and surveys at Finale (n = 55 teams), and 3-12 months post-training (n = 34 teams). RESULTS: Innovations related to medical devices (33%), drugs/biologics (20%), software applications (16%), and diagnostics (8%). An average of 24 interviews was conducted. Teams reported increased readiness for commercialization over time (83%, 9 months; 14%, 3 months). Thirty-nine percent met with institutional technology transfer to pursue licensing/patents and 24% pursued venture capital/investor funding following the short courses. CONCLUSIONS: I-Corps@NCATS training provided the NCATS teams a rigorous and repeatable process to aid development of a business model based on customer needs. Outcomes of this pilot program support the expansion of I-Corps™ training to biomedical scientists for accelerating research translation.