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.

Informed choice about breast cancer prevention: randomized controlled trial of an online decision aid intervention.

INTRODUCTION: Tamoxifen and raloxifene are chemopreventive drugs that can reduce women's relative risk of primary breast cancer by 50%; however, most women eligible for these drugs have chosen not to take them. The reasons for low uptake may be related to women's knowledge or attitudes towards the drugs. We aimed to examine the impact of an online breast cancer chemoprevention decision aid (DA) on informed intentions and decisions of women at high risk of breast cancer. METHODS: We conducted a randomized clinical trial, assessing the effect of a DA about breast cancer chemoprevention on informed choices about chemoprevention. Women (n = 585), 46- to 74-years old old, completed online baseline, post-test, and three-month follow-up questionnaires. Participants were randomly assigned to either an intervention group, a standard control group that answered questions about chemoprevention at baseline, or a three-month control group that did not answer questions about chemoprevention at baseline. The main outcome measures were whether women's intentions and decisions regarding chemoprevention drugs were informed, and whether women who viewed the DA were more likely to make informed decisions than women who did not view the DA, using a dichotomous composite variable 'informed choice' (yes/no) to classify informed decisions as those reflecting sufficient knowledge and concordance between a woman's decision and relevant attitudes. RESULTS: Analyses showed that more intervention than standard control participants (52.7% versus 5.9%) made informed decisions at post-test, P <0.001. At the three-month follow-up, differences in rates of informed choice between intervention (16.9%) and both control groups (11.8% and 8.0%) were statistically non-significant, P = 0.067. CONCLUSIONS: The DA increased informed decision making about breast cancer chemoprevention, although the impact on knowledge diminished over time. This study was not designed to determine how much knowledge decision makers must retain over time. Examining informed decisions increases understanding of the impact of DAs. A standard for defining and measuring sufficient knowledge for informed decisions is needed. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00967824

Patients' and family members' views on patient-centered communication during cancer care.

OBJECTIVES: To explore patients' and family members' views on communication during cancer care and to identify those aspects of clinician-patient communication which were most important to patients and family members. METHODS: We conducted a secondary data analysis of qualitative data from 137 patients with cancer and family members of patients with cancer. We used a modified version of the constant comparative method and coding paradigm of grounded theory. RESULTS: Patients want sensitive, caring clinicians who provide information that they need, when they need it, in a way that they can understand; who listen and respond to questions and concerns, and who attempt to understand the patient's experience. Effective information exchange and a positive interpersonal relationship with the clinician were of fundamental importance to patients and family members. These were interrelated; for instance, failure to provide information a patient needed could damage the relationship, whereas excellent listening could foster the relationship. Information exchange and relationship were also integral to decision-making, managing uncertainty, responding to emotions, and self-management. Clinicians who were responsive to patients' needs beyond the immediate medical encounter were valued. CONCLUSIONS: The complexity of cancer care today suggests that efforts to improve communication must be multilevel, acknowledging and addressing patient, clinician, organizational and policy barriers, and facilitators. Measurement tools are needed to assess cancer patients' and family members' experiences with communication over the course of cancer care to provide meaningful, actionable feedback to those seeking to optimize their effectiveness in communicating with patients with cancer.

Implementing the learning health system: from concept to action.

Clinicians and health systems are facing widespread challenges, including changes in care delivery, escalating health care costs, and the need to keep up with rapid scientific discovery. Reorganizing U.S. health care and changing its practices to render better, more affordable care requires transformation in how health systems generate and apply knowledge. The "rapid-learning health system"-posited as a conceptual strategy to spur such transformation-leverages recent developments in health information technology and a growing health data infrastructure to access and apply evidence in real time, while simultaneously drawing knowledge from real-world care-delivery processes to promote innovation and health system change on the basis of rigorous research. This article describes an evolving learning health system at Group Health Cooperative, the 6 phases characterizing its approach, and examples of organization-wide applications. This practical model promotes bidirectional discovery and an open mind at the system level, resulting in willingness to make changes on the basis of evidence that is both scientifically sound and practice-based. Rapid learning must be valued as a health system property to realize its full potential for knowledge generation and application.

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.

Can integrating health literacy into the patient-centered medical home help us weather the perfect storm?

Improving health literacy is one key to buoying our nation's troubled health care system. As system-level health literacy improvement strategies take the stage among national priorities for health care, the patient-centered medical home (PCMH) model of care emerges as a compelling avenue for their widespread implementation. With a shared focus on effective communication and team-based care organized around patient needs, health literacy principles and the PCMH are well aligned. However, their synergy has received little attention, even as PCMH demonstration projects and health literacy interventions spring up nationwide. While many health literacy interventions are limited by their focus on a single point along the continuum of care, creating a "room" for health literacy within the PCMH may finally provide a multi-dimensional, system-level approach to tackling the full range of health literacy challenges. Increasing uptake coupled with federal support and financial incentives further boosts the model's potential for advancing health literacy. On the journey toward a revitalized health care system, integrating health literacy into the PCMH presents a promising opportunity that deserves consideration.

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.

Twelve evidence-based principles for implementing self-management support in primary care.

BACKGROUND: Recommendations to improve self-management support and health outcomes for people with chronic conditions in primary care settings are provided on the basis of expert opinion supported by evidence for practices and processes. Practices and processes that could improve self-management support in primary care were identified through a nominal group process. In a targeted search strategy, reviews and meta-analyses were then identifed using terms from a wide range of chronic conditions and behavioral risk factors in combination with Self-Care, Self-Management, and Primary Care. On the basis of these reviews, evidence-based principles for self-management support were developed. FINDINGS: The evidence is organized within the framework of the Chronic Care Model. Evidence-based principles in 12 areas were associated with improved patient self-management and/or health outcomes: (1) brief targeted assessment, (2) evidence-based information to guide shared decision-making, (3) use of a nonjudgmental approach, (4) collaborative priority and goal setting, (5) collaborative problem solving, (6) self-management support by diverse providers, (7) self-management interventions delivered by diverse formats, (8) patient self-efficacy, (9) active followup, (10) guideline-based case management for selected patients, (11) linkages to evidence-based community programs, and (12) multifaceted interventions. A framework is provided for implementing these principles in three phases of the primary care visit: enhanced previsit assessment, a focused clinical encounter, and expanded postvisit options. CONCLUSIONS: There is a growing evidence base for how self-management support for chronic conditions can be integrated into routine health care.

Media messages about cancer: what do people understand?

Health messages on television and other mass media have the potential to significantly influence the public's health-related knowledge and behaviors, but little is known about people's ability to comprehend such messages. To investigate whether people understood the spoken information in media messages about cancer prevention and screening, we recruited 44 adults from 3 sites to view 6 messages aired on television and the internet. Participants were asked to paraphrase main points and selected phrases. Qualitative analysis methods were used to identify what content was correctly and accurately recalled and paraphrased, and to describe misunderstandings and misconceptions. While most participants accurately recalled and paraphrased the gist of the messages used here, overgeneralization (e.g., believing preventative behaviors to be more protective than stated), loss of details (e.g., misremembering the recommended age for screening), and confusion or misunderstandings around specific concepts (e.g., interpreting "early stage" as the stage in one's life rather than cancer stage) were common. Variability in the public's ability to understand spoken media messages may limit the effectiveness of both pubic health campaigns and provider-patient communication. Additional research is needed to identify message characteristics that enhance understandability and improve comprehension of spoken media messages about cancer.

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.

Challenges in researching racially sensitive topics in HMOs.

When research designed to close the disparities gap is conducted in real-world health care settings, unique sensitivities may arise, particularly when race is the focus of interventions. Researchers encountered this issue in the course of a randomized trial investigating the influence of ethnic identity (EI) among African American (AA) study participants. The study was conducted by the research programs at three health maintenance organizations (HMOs) and the University of Michigan Center for Health Communications Research, as described in this issue of the journal (Resnicow et al., 2009). This commentary describes the research partnership's concerns for the racially sensitive nature of the study and the precautions undertaken to mitigate them. The research study's experiences may be informative and insightful for health plans and research centers invested in health disparities research.

Looking at research consent forms through a participant-centered lens: the PRISM readability toolkit.

Communicating in lay language is an underdeveloped skill among many researchers-a limitation that contributes to low readability among research consent forms and may hinder participant understanding of study procedures and risks. We present the Project to Review and Improve Study Materials (PRISM) and its centerpiece, the PRISM Readability Toolkit. The toolkit provides strategies for creating study materials that are readable and participant centered, focusing on consent forms but also addressing other participant materials. Based on plain language principles, this free resource includes a flexible menu of tools, such as an editing checklist, before and after examples, easy-to-read template language, and a list of alternative words. Among PRISM's ongoing goals is to test the toolkit with populations groups.

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.