Gathering speed and countering tensions in the rapid learning health system.

The vision of the learning health system (LHS), conceptualized 15 years ago, is for the rapid generation, use, and spread of high-quality evidence that yields better health experiences, outcomes, efficiencies, and equity in everyday practice settings across communities. However, despite the emergence of many useful LHS frameworks and examples to guide adoption, large gaps remain in the speed and consistency with which evidence is generated and used across the range of settings from the bedside to the policy table. Gaps in progress are not surprising, however, given the tensions that predictably arise when key stakeholders-researchers, health systems, and funders-comingle in these efforts. This commentary examines eight core tensions that naturally arise and offers practical actions that stakeholders can take to address these tensions and speed LHS adoption. The urgency for attenuating these tensions and accelerating health system improvements has never been higher. Timeliness, rigor, and prioritization can be aligned across stakeholders, but only if all partners are intentional about the operational and cultural challenges that exist.

Learning health system, positive deviance analysis, and electronic health records: Synergy for a learning health system.

Introduction: Over the past decade, numerous efforts have encouraged the realization of the learning health system (LHS) in the United States. Despite these efforts, and promising aims of the LHS, the full potential and value of research conducted within LHSs have yet to be realized. New technology coupled with a catalyzing global pandemic have spurred momentum. In addition, the LHS has lacked a consistent framework within which "best evidence" can be identified. Positive deviance analysis, itself reinvigorated by recent advances in health information technology (IT) and ubiquitous adoption of electronic health records (EHRs), may finally provide a framework through which LHSs can be operationalized and optimized. Methods: We describe the synergy between positive deviance and the LHS and how they may be integrated to achieve a continuous cycle of health system improvement. Results: As we describe below, the positive deviance approach focuses on learning from high-performing teams and organizations. Conclusion: Such learning can be enabled by EHRs and health IT, providing a lens into how digital clinical interventions are successfully developed and deployed.

Positioning patients to partner: exploring ways to better integrate patient involvement in the learning health systems.

Globally, health systems are increasingly striving to deliver evidence based care that improves patients', caregivers' and communities' health outcomes. To deliver this care, more systems are engaging these groups to help inform healthcare service design and delivery. Their lived experiences-experiences accessing and/or supporting someone who accesses healthcare services-are now viewed by many systems as expertise and an important part of understanding and improving care quality. Patients', caregivers' and communities' participation in health systems can range from healthcare organizational design to being members of research teams. Unfortunately, this involvement greatly varies and these groups are often sidelined to the start of research projects, with little to no role in later project stages. Additionally, some systems may forgo direct engagement, focusing solely on patient data collection and analysis. Given the benefits of active patient, caregiver and community participation in health systems on patient health outcomes, systems have begun identifying different approaches to studying and applying findings of patient, caregiver and community informed care initiatives in a rapid and consistent fashion. The learning health system (LHS) is one approach that can foster deeper and continuous engagement of these groups in health systems change. This approach embeds research into health systems, continuously learning from data and translating findings into healthcare practices in real time. Here, ongoing patient, caregiver and community involvement is considered vital for a well functioning LHS. Despite their importance, great variability exists as to what their involvement means in practice. This commentary examines the current state of patient, caregiver and community participation in the LHS. In particular, gaps in and need for resources to support their knowledge of the LHS are discussed. We conclude by recommending several factors health systems must consider in order to increase participation in their LHS. Systems must: (1) assess patients', caregivers and community understanding of how their feedback are used in the LHS and how collected data are used to inform patient care; (2) review the level and extent of these groups' participation in health system improvement activities; and (3) examine whether health systems have the workforce, capacity and infrastructure to nurture continuous and impactful engagement.

Patients, caregivers and communities have started taking more hands on roles in health systems, partnering with healthcare providers and researchers to impact the ways healthcare services are made and delivered. Their input has been shown to improve patient health. While many systems are working to include patients, caregivers and communities in helping improve healthcare, this work often focuses on collecting and analyzing patient data without using it in a timely way. Also, the level of their input can vary and is often limited to the start of a research project. As more health systems recognize the importance of their input in creating better healthcare, some are using different approaches to make this feedback a constant part of their systems. The learning health system (LHS) is one approach that can support deeper and ongoing patient, caregiver and community involvement in health system change. In the LHS, projects are frequently reviewed and feedback used to help health systems make changes as they go. While their involvement is critical to a well functioning LHS, it is unclear what this involvement looks like. This commentary reviews the current state of this involvement. We offer readers a way forward and suggestions to help them determine if they are actively including patients, caregivers and communities in their LHS. Suggestions include reviewing: (1) the ways data are collected and used; (2) how patients, caregivers and communities are involved in health system improvement efforts; and (3) whether or not systems have the tools needed to frequently partner with these groups.

One size does not fit all: Insights for engaging front-line clinicians in pragmatic clinical trials.

INTRODUCTION: Despite the proliferation of pragmatic clinical trials (PCTs) conducted in health care delivery settings, we know relatively little about how practicing clinicians perceive their potential roles in such research. Empirical evidence and practical guidance concerning clinician engagement in research is needed to inform the design and successful implementation of PCTs. METHODS: We conducted a two-phase qualitative study to better understand how and to what extent practicing clinicians should be involved in PCTs and to develop guidance for researchers on engaging front-line clinicians in PCTs. In phase one, clinicians who spend the majority of their time providing direct patient care participated in 90-min focus groups. In phase two, we conducted key informant interviews with PCT research teams and clinicians participating in the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) trial. RESULTS: Thirty-four physicians, nurses, and other care providers from four health care delivery organizations participated in focus groups. Focus group participants stressed the importance of engaging clinicians early in the PCT planning process to identify clinically relevant study questions, provide input on study design, and customize study protocols to fit unique clinic workflows. We conducted 18 interviews with principal investigators, project managers, and clinicians involved in the ADAPTABLE trial across six clinical data research networks. Study team members described trying multiple approaches to optimize in-clinic recruitment and enrollment of eligible patients. Successful strategies involved several key factors related to research team interactions with eligible patients, clinicians, and clinic staff. CONCLUSIONS: More active involvement by a range of clinical stakeholders in PCT planning may help researchers avoid common barriers to trial implementation. We propose a "medium-touch" approach to involving clinicians in PCT recruitment and enrollment that focuses clinician effort where it is most critical-to reassure eligible patients that trial participation is a safe alternative for them.

Recommendations for strengthening the role of embedded researchers to accelerate implementation in health systems: Findings from a state-of-the-art (SOTA) conference workgroup.

BACKGROUND: Traditional research approaches do not promote timely implementation of evidence-based innovations (EBIs) to benefit patients. Embedding research within health systems can accelerate EBI implementation by blending rigorous methods with practical considerations in real-world settings. A state-of-the-art (SOTA) conference was convened in February 2019 with five workgroups that addressed five facets of embedded research and its potential to impact healthcare. This article reports on results from the workgroup focused on how embedded research programs can be implemented into heath systems for greatest impact. METHODS: Based on a pre-conference survey, participants indicating interest in accelerating implementation were invited to participate in the SOTA workgroup. Workgroup participants (N = 26) developed recommendations using consensus-building methods. Ideas were grouped by thematic clusters and voted on to identify top recommendations. A summary was presented to the full SOTA membership. Following the conference, the workgroup facilitators (LJD, CDH, NR) summarized workgroup findings, member-checked with workgroup members, and were used to develop recommendations. RESULTS: The workgroup developed 12 recommendations to optimize impact of embedded researchers within health systems. The group highlighted the tension between "ROI vs. R01" goals-where health systems focus on achieving return on their investments (ROI) while embedded researchers focus on obtaining research funding (R01). Recommendations are targeted to three key stakeholder groups: researchers, funders, and health systems. Consensus for an ideal foundation to support optimal embedded research is one that (1) maximizes learning; (2) aligns goals across all 3 stakeholders; and (3) implements EBIs in a consistent and timely fashion. CONCLUSIONS: Four cases illustrate a variety of ways that embedded research can be structured and conducted within systems, by demonstrating key embedded research values to enable collaborations with academic affiliates to generate actionable knowledge and meaningfully accelerate implementation of EBIs to benefit patients. IMPLICATIONS: Embedded research approaches have potential for transforming health systems and impacting patient health. Accelerating embedded research should be a focused priority for funding agencies to maximize a collective return on investment.

Rethinking ethical oversight in the era of the learning health system.

Opportunities to advance science increasingly arise through investigations embedded within routine clinical practice in the form of learning health systems. Such activities challenge conventional approaches to research regulation that have not caught up with those opportunities, often imposing burdens generalized from riskier research. We analyze the rules and conventions in the US, demonstrating how even those rules are compatible with a much more flexible approach to participant risk, institutional oversight, participant consent, and disclosure for low-risk learning activities in all jurisdictions.

Celebrating a Quarter-Century of Public Domain Research: 25th Annual Conference of the Health Care Systems Research Network.

The 25th annual conference of the Health Care Systems Research Network (HCSRN) was held April 10-12 in Portland, Oregon, attracting 420 attendees. The HCSRN, a consortium of 18 community-based research organizations embedded in or affiliated with large health care delivery systems, has hosted annual research conferences since 1994. The primary objective of the conference is to convene researchers, project staff, funders, and other stakeholders to share latest scientific findings and cultivate new partnerships among research teams, patients, and clinicians. Collaboration is the cornerstone of the HCSRN's success; the conference serves as a catalyst for a variety of collaborative ventures as well as tactics and approaches to more effective and efficient research. This year's program included 70 distinct scientific presentations, plus nearly 100 posters, and spanned diverse content offerings that mirrored the diversity of the HCSRN and its collaborators. Plenary sessions imparted insights on ways that data science and approaches to collaborative design in health care can speed the translation of research into practice.

We've Only Just Begun - Insights from a 25-Year Journey to Accelerate Health Care Transformation Through Delivery System Research.

Even though it is well known that quality, safety, and patient-centeredness of health care can be improved, leveraging the organizational apparatus of a care delivery environment to render improvement in a consistent and comprehensive manner has proven difficult. The Health Care Systems Research Network (HCSRN), which began as the HMO Research Network, emerged from a desire to improve health and study problems in health care in a systematic and collaborative way, spurring the delivery of true evidence-informed medicine. The HCSRN has honed network-wide data resources, a collaborative culture, and shared infrastructure, enabling multicenter health care research that is often more difficult for researchers working in less integrated settings and across organizational boundaries. The HCSRN's 25-year track record confers both an opportunity and obligation to share what we have learned through our research. Considering the quarter-century since the HCSRN was established, we describe three evolving areas-health data, new health care models, and diversified research teams that must be thoughtfully harnessed to realize a transformed health care ecosystem that generates and learns with research.

"You Really Do Have to Know the Local Context": IRB Administrators and Researchers on the Implications of the NIH Single IRB Mandate for Multisite Genomic Studies.

In 2016, the U.S. National Institutes of Health (NIH) announced a new policy requiring single institutional review board (sIRB) review for multisite studies. However, adherence to the new policy requires the separation of regulatory institutional review board (IRB) work per Federal guidance from site-specific local compliance concerns. In particular, genomic research is subject to a wide range of state laws, institutional requirements, and local population preferences. In this qualitative study, we explored the anticipated needs of genomics researchers and IRB administrators around implementing the policy. We observed multiple uncertainties, particularly about intersite communication processes, sIRB selection processes, and roles of the reviewing IRB and local sites regarding local context information relevant to genomics. Optimal implementation of the NIH policy may require additional guidance for researchers and IRB administrators.

Collaborating on Data, Science, and Infrastructure: The 20-Year Journey of the Cancer Research Network.

The Cancer Research Network (CRN) is a consortium of 12 research groups, each affiliated with a nonprofit integrated health care delivery system, that was first funded in 1998. The overall goal of the CRN is to support and facilitate collaborative cancer research within its component delivery systems. This paper describes the CRN's 20-year experience and evolution. The network combined its members' scientific capabilities and data resources to create an infrastructure that has ultimately supported over 275 projects. Insights about the strengths and limitations of electronic health data for research, approaches to optimizing multidisciplinary collaboration, and the role of a health services research infrastructure to complement traditional clinical trials and large observational datasets are described, along with recommendations for other research consortia.

From Principles to Practice: Real-World Patient and Stakeholder Engagement in Breast Cancer Research.

The Patient-Centered Outcomes Research Institute (PCORI) in Washington, DC, has catalyzed a meaningful shift in the composition of research project teams since its initial research funding cycle in 2011. Despite the influx of funding in the research community for patient-centered research, research on how to effectively engage patients and stakeholders in the research process is still relatively nascent. Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, WA, was an early recipient of PCORI research funding and, as of December 2017, has received 8 PCORI research awards totaling nearly $15 million. Anticipating the pivotal importance of PCORI's patient-focused approach, KPWHRI developed a set of 8 principles to guide how research teams should work with patients and other stakeholders to simultaneously achieve research aims and embrace this new paradigm in how research teams collaborate. With a goal of assisting other research teams, this article describes the genesis of the KPWHRI principles, their relevance to patient- and stakeholder-engaged research, and how these principles were brought to life in the context of a specific PCORI-funded project on surveillance imaging in women after a breast cancer diagnosis.

Improving Health and Well-Being: Connecting Research and Practice. The 24th Annual Conference of the Health Care Systems Research Network.

The 24th annual conference of the Health Care Systems Research Network (HCSRN, formerly the HMO Research Network), held April 11-13, 2018, in Minneapolis, Minnesota, attracted 357 attendees. The HCSRN is a consortium of 18 community-based research organizations embedded in or affiliated with large health care delivery systems. Its annual research conference, held since 1994, is a unique venue that brings diverse stakeholders (eg, research teams, clinicians, patients, funders) together to explore a range of health research topics and scientific findings, with a unifying goal of connecting applied research to real-world care delivery for the betterment of individual and community health. The 2018 conference was hosted by Minneapolis-based HealthPartners Institute and organized around 3 tracks: Research & Results, Practical Application, and Data Science & Informatics. Themes of the 4 plenary, 7 panel, 36 oral abstract, and 111 poster presentations included the learning health system, the opioid epidemic, health disparities, high costs of care, informing population health policy with evidence, and how to use storytelling to present data to inspire change, among others.

Advancing Learning Health Systems Through Embedded Research: The 23rd Annual Conference of the Health Care Systems Research Network.

The 23rd annual conference of the Health Care Systems Research Network (HCSRN, formerly the HMO Research Network) was held in San Diego, California, March 21-23, 2017, attracting 387 attendees. As a consortium of 20 research organizations embedded in or affiliated with large health care delivery organizations, the HCSRN has held annual research conferences since 1994. The overall aim of the conferences is to bring researchers, project staff, research funders and other stakeholders together to share latest scientific findings and foster new research ideas and collaborations. The 2017 conference was hosted by the Palo Alto Medical Foundation Research Institute. Each host site takes responsibility for the content and structure of the conference, and the 2017 team introduced several new features. In particular, past conferences used concurrent sessions to present research results in different topical areas, such as chronic disease, cancer, health informatics, mental health or precision medicine. This year, concurrent sessions shifted to panel discussions about how research results were achieved, including the use of methods, partnerships and analytic approaches. The 35 panels were organized into tracks such as engagement, data and informatics, partnerships and research implementation. Scientific results from HCSRN projects were presented via 120 posters in two poster sessions. Plenary sessions included a town hall-style panel with different funding agency representatives, an opening presentation on the range of opportunities and benefits to studying health systems, and a concluding presentation on how researchers can apply design thinking in their work.

Primary care physicians' willingness to disclose oncology errors involving multiple providers to patients.

BACKGROUND: Full disclosure of harmful errors to patients, including a statement of regret, an explanation, acceptance of responsibility and commitment to prevent recurrences is the current standard for physicians in the USA. OBJECTIVE: To examine the extent to which primary care physicians' perceptions of event-level, physician-level and organisation-level factors influence intent to disclose a medical error in challenging situations. DESIGN: Cross-sectional survey containing two hypothetical vignettes: (1) delayed diagnosis of breast cancer, and (2) care coordination breakdown causing a delayed response to patient symptoms. In both cases, multiple physicians shared responsibility for the error, and both involved oncology diagnoses. SETTING: The study was conducted in the context of the HMO Cancer Research Network Cancer Communication Research Center. PARTICIPANTS: Primary care physicians from three integrated healthcare delivery systems located in Washington, Massachusetts and Georgia; responses from 297 participants were included in these analyses. MAIN MEASURES: The dependent variable intent to disclose included intent to provide an apology, an explanation, information about the cause and plans for preventing recurrences. Independent variables included event-level factors (responsibility for the event, perceived seriousness of the event, predictions about a lawsuit); physician-level factors (value of patient-centred communication, communication self-efficacy and feelings about practice); organisation-level factors included perceived support for communication and time constraints. KEY RESULTS: A majority of respondents would not fully disclose in either situation. The strongest predictors of disclosure were perceived personal responsibility, perceived seriousness of the event and perceived value of patient-centred communication. These variables were consistently associated with intent to disclose. CONCLUSION: To make meaningful progress towards improving disclosure; physicians, risk managers, organisational leaders, professional organisations and accreditation bodies need to understand the factors which influence disclosure. Such an understanding is required to inform institutional policies and provider training.

Privacy and confidentiality in pragmatic clinical trials.

With pragmatic clinical trials, an opportunity exists to answer important questions about the relative risks, burdens, and benefits of therapeutic interventions. However, concerns about protecting the privacy of this information are significant and must be balanced with the imperative to learn from the data gathered in routine clinical practice. Traditional privacy protections for research uses of identifiable information rely disproportionately on informed consent or authorizations, based on a presumption that this is necessary to fulfill ethical principles of respect for persons. But frequently, the ideal of informed consent is not realized in its implementation. Moreover, the principle of respect for persons­which encompasses their interests in health information privacy­can be honored through other mechanisms. Data anonymization also plays a role in protecting privacy but is not suitable for all research, particularly pragmatic clinical trials. In this article, we explore both the ethical foundation and regulatory framework intended to protect privacy in pragmatic clinical trials. We then review examples of novel approaches to respecting persons in research that may have the added benefit of honoring patient privacy considerations.

Oversight on the borderline: Quality improvement and pragmatic research.

Pragmatic research that compares interventions to improve the organization and delivery of health care may overlap, in both goals and methods, with quality improvement activities. When activities have attributes of both research and quality improvement, confusion often arises about what ethical oversight is, or should be, required. For routine quality improvement, in which the delivery of health care is modified in minor ways that create only minimal risks, oversight by local clinical or administrative leaders utilizing institutional policies may be sufficient. However, additional consideration should be given to activities that go beyond routine, local quality improvement to first determine whether such non-routine activities constitute research or quality improvement and, in either case, to ensure that independent oversight will occur. This should promote rigor, transparency, and protection of patients' and clinicians' rights, well-being, and privacy in all such activities. Specifically, we recommend that (1) health care organizations should have systematic policies and processes for designating activities as routine quality improvement, non-routine quality improvement, or quality improvement research and determining what oversight each will receive. (2) Health care organizations should have formal and explicit oversight processes for non-routine quality improvement activities that may include input from institutional quality improvement experts, health services researchers, administrators, clinicians, patient representatives, and those experienced in the ethics review of health care activities. (3) Quality improvement research requires review by an institutional review board; for such review to be effective, institutional review boards should develop particular expertise in assessing quality improvement research. (4) Stakeholders should be included in the review of non-routine quality improvement and quality improvement-related research proposals. Only by doing so will we optimally leverage both pragmatic research on health care delivery and local implementation through quality improvement as complementary activities for improving health.

Providers' perceptions of communication breakdowns in cancer care.

BACKGROUND: Communication breakdowns in cancer care are common and represent a failure in patient-centered care. While multiple studies have elicited patients' perspectives on these breakdowns, little is known about cancer care providers' attitudes regarding the causes and potential solutions. OBJECTIVE: To examine providers' (1) perceptions of the nature and causes of communication breakdowns with patients in cancer care and (2) suggestions for managing and preventing breakdowns. DESIGN: Qualitative study of nine focus groups held at three sites (Massachusetts, Georgia and Washington). PARTICIPANTS: Fifty-nine providers: 33% primary care physicians, 14% oncologists, 36% nurses, and 17% nurse practitioners, physician assistants, and others. APPROACH: Directed content analysis of focus group transcripts. KEY RESULTS: Providers' perceptions of the causes of communication breakdowns fell into three categories: causes related to patients, providers, or healthcare systems. Providers perceived that patients sometimes struggle to understand cancer and health-related information, have unrealistic expectations, experience emotional and psychological distress that interferes with information exchange; and may be reticent to share their confusion or concerns. Providers described their own and colleagues' contributions to these breakdowns as sharing inaccurate, conflicting, or uncoordinated information. Providers also described the difficulty in balancing hope with reality in discussions of prognosis. System issues named by providers included insufficient time with patients, payment systems, and changing protocols that inhibit communication and coordination of care. Potential solutions included greater patient engagement, team coordination, and systems that promote patient feedback. CONCLUSIONS: Providers described multiple causes for communication breakdowns at the patient, provider, and system level. Multi-level interventions that coordinate care and encourage feedback may help to address or prevent communication breakdowns.