Meeting Report: Vaccine Stability Considerations to Enable Rapid Development and Deployment

The Stability Community of the American Association of Pharmaceutical Scientists (AAPS) held a virtual workshop on “Vaccine Stability Considerations to Enable Rapid Development and Deployment”, on March 24-25, 2021. The workshop included distinguished speakers and panelists from across the industry, academia, regulatory agencies, as well as health care leaders. This paper presents a review of the topics covered. Specifically the challenges in accelerating vaccine development and analytical characterization techniques to establish shelf-life were covered. Additionally, vaccine stability modeling using prior knowledge stability models and advanced kinetic analysis played a key in the EUA approaches discussed during the workshop. Finally, the role of stability studies in addressing the challenges of vaccine distribution and deployment during the pandemic were a focus of presentations and panel discussions.Although the workshop did not have any presentation topics directly dedicated to the mRNA vaccines, the techniques discussed are generally applicable. The mRNA vaccine developers were represented in the panel discussions, where experts involved in the EUA approval/deployment stages for this vaccine type could discuss the challenges as applied to their vaccines.

Clinician and Health Care Leaders' Experiences with—and Perceptions of—COVID-19 Documentation Reduction Policies and Practices

Background Substantial strategies to reduce clinical documentation were implemented by health care systems throughout the coronavirus disease-2019 (COVID-19) pandemic at national and local levels. This natural experiment provides an opportunity to study the impact of documentation reduction strategies on documentation burden among clinicians and other health professionals in the United States. Objectives The aim of this study was to assess clinicians' and other health care leaders' experiences with and perceptions of COVID-19 documentation reduction strategies and identify which implemented strategies should be prioritized and remain permanent post-pandemic. Methods We conducted a national survey of clinicians and health care leaders to understand COVID-19 documentation reduction strategies implemented during the pandemic using snowball sampling through professional networks, listservs, and social media. We developed and validated a 19-item survey leveraging existing post-COVID-19 policy and practice recommendations proposed by Sinsky and Linzer. Participants rated reduction strategies for impact on documentation burden on a scale of 0 to 100. Free-text responses were thematically analyzed. Results Of the 351 surveys initiated, 193 (55%) were complete. Most participants were informaticians and/or clinicians and worked for a health system or in academia. A majority experienced telehealth expansion (81.9%) during the pandemic, which participants also rated as highly impactful (60.1–61.5) and preferred that it remain (90.5%). Implemented at lower proportions, documenting only pertinent positives to reduce note bloat (66.1 ± 28.3), changing compliance rules and performance metrics to eliminate those without evidence of net benefit (65.7 ± 26.3), and electronic health record (EHR) optimization sprints (64.3 ± 26.9) received the highest impact scores compared with other strategies presented; support for these strategies widely ranged (49.7–63.7%). Conclusion The results of this survey suggest there are many perceived sources of and solutions for documentation burden. Within strategies, we found considerable support for telehealth, documenting pertinent positives, and changing compliance rules. We also found substantial variation in the experience of documentation burden among participants.

Improving Quality in Primary Care: A Model for Change

Health care spending accounts for 17.7% of the gross domestic product in the United States, and it is expected to continue rising at an annual rate of 5.3%. Despite high costs, health care quality lags behind other high-income countries; yet, over 70% of change initiatives fail. The purpose of this multiple case study was to explore strategies primary care leaders use for implementing quality improvement initiatives to improve patient outcomes and reduce waste in primary care facilities. The target population consisted of 3 health care leaders of 3 primary care facilities in southern California who successfully implemented quality improvement initiatives. The conceptual framework for this study was Kotter’s 8-step of change management. Data were collected through face-to-face semi-structured interviews with senior health care leaders, document review, and quality reports. Patterns were identified through a rigorous process of data familiarization, data coding, and theme development and revision. Interpretations from the data were subjected to member-checking to ensure trustworthiness of the findings. Four themes emerged from this study: communication, leadership support, inclusive decision-making, and employee recognition.

Strategies during digital transformation to make progress in achievement of sustainable development by 2030

Purpose The purpose of this study is to explore strategies during transformation to obtain sustainable development and to identify the human-based factors contributing to the transformation. Design/methodology/approach This qualitative study explored the strategies that health-care leaders need to adopt during transformation to achieve the Sustainable Development of the United Nations' agenda by 2030. The study was conducted in early 2020 among ten health-care leaders in the USA. The research design was an exploratory qualitative approach that used a semi-structured, open-ended questionnaire asked of ten US health-care leaders who had experience in leading health-care transformation in their organizations. The study findings identified that health-care leaders can facilitate the achievement of Sustainable Development by establishing strategies in knowledge improvement, innovation development, motivation increment, global strategy and local strategy alignment, leadership support and partnership development. Findings Six major themes emerged from the data linked to the central research question: “What are the strategies during digital transformation to make progress in the achievement of Sustainable Development by 2030?” The compressed collection of themes for the study included the following six major themes: knowledge development; innovation development; motivation; global strategy establishment; leadership; collaboration enhancement; and two minor themes, namely, mindset change and vision creation. Research limitations/implications Due to the few numbers of participants selected for this study (N = 10) may not be generalizable to other settings. The implication of this study is to identify the significant factors contributing to making progress in sustainable development in health-care organizations. The health-care leaders can learn what significant strategies can be helpful to establish future-based organizations toward achieving sustainability. Practical implications The results of this study provided actionable strategies to empower the employees and increase managerial innovation in health-care organizations. Social implications Promoting partnership of health-care organizations with social and global activities such as sustainable development goals that are contributing in 5Ps: People, Prosperity, Peace, Partnership and Planet. Originality/value The main reason for the study was that health-care leaders worldwide could have a novel study that delineates the digital transformation strategies needed for creating impactful outcomes toward achieving sustainable development. Moreover, this unique study provided a useful outlook for health-care leaders to establish future-based health-care organizations while learning the dynamic of digital transformation is the key for health-care organizations to adapt their strategies for a sustainable future.

Transformational Executive Health-Care Leadership: What Makes a Good and Great Health-Care Leader?

Health-care leaders work at the highest levels of organizations and face unique challenges in today's health-care systems. This article reports the lived experiences of an executive nurse to better understand their leadership journey and leadership shadow, exploring their professional development of health-care leadership while navigating change and conflict by interpreting critical turning points in their career and triangulating data to identify and analyze central themes. Offering a real-world perspective, the article uses personal reflection aligned to professional inquiry, workplace observations, document reviews, and personal accounts to focus on executive nursing and the construction of a social movement from within a large managed care organization. The purpose of this evaluation is to create deeper understandings of ways in which to improve patient and provider experiences, reduce system waste, and improve population health. The theme of transformational leadership emerged, and new insights were created to inform future thinking.