Patient engagement in designing, conducting, and disseminating clinical pain research: IMMPACT recommended considerations.

ABSTRACT: In the traditional clinical research model, patients are typically involved only as participants. However, there has been a shift in recent years highlighting the value and contributions that patients bring as members of the research team, across the clinical research lifecycle. It is becoming increasingly evident that to develop research that is both meaningful to people who have the targeted condition and is feasible, there are important benefits of involving patients in the planning, conduct, and dissemination of research from its earliest stages. In fact, research funders and regulatory agencies are now explicitly encouraging, and sometimes requiring, that patients are engaged as partners in research. Although this approach has become commonplace in some fields of clinical research, it remains the exception in clinical pain research. As such, the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials convened a meeting with patient partners and international representatives from academia, patient advocacy groups, government regulatory agencies, research funding organizations, academic journals, and the biopharmaceutical industry to develop consensus recommendations for advancing patient engagement in all stages of clinical pain research in an effective and purposeful manner. This article summarizes the results of this meeting and offers considerations for meaningful and authentic engagement of patient partners in clinical pain research, including recommendations for representation, timing, continuous engagement, measurement, reporting, and research dissemination.

Examining how study teams manage different viewpoints and priorities in patient-centered outcomes research: Results of an embedded multiple case study.

INTRODUCTION: Limited evidence exists about which patient and stakeholder engagement practices support or hinder study teams as they negotiate different viewpoints in decisions about the design and conduct of patient-centered outcomes research. METHODS: We applied a multiple-embedded descriptive case study design for six studies funded by the Patient-Centered Outcomes Research Institute (PCORI). We interviewed 32 researchers and stakeholder partners, including patients, caregivers and clinicians, and reviewed documents related to each study (e.g., publications, and progress reports submitted to PCORI). FINDINGS: Overall, researchers reported that incorporating different viewpoints was a strength or opportunity to learn rather than something to be avoided or dreaded. Across cases, different viewpoints and priorities, often related to ethical or pragmatic considerations, emerged between researchers and stakeholders, between stakeholder groups (e.g., patients and clinicians) or within groups (e.g., amongst researchers). Examples of navigating different viewpoints arose across study phases. The length of time to resolve issues depended on how strongly people disagreed and the perceived importance or impact of decisions on the study. All cases used collaborative decision-making approaches, often described as consensus, throughout the study. Interviewees described consensus as using negotiation, compromise or working towards an agreeable decision. To encourage consensus, cases actively facilitated group discussions with an openness to diverse opinions, remained flexible and open to trying new things, referenced a ground rule or common goal and delegated decisions to partners or smaller workgroups. When viewpoints were not easily resolved, cases used different approaches to reach final decisions while maintaining relationships with partners, such as elevating decisions to leadership or agreeing to test out an approach. No one engagement structure (e.g., advisory group, coinvestigator) stood out as better able to manage different viewpoints. Teams adjusted engagement structures and behaviours to facilitate an overall culture of inclusion and respect. Partners acknowledged the intentional efforts of researchers to incorporate their perspectives, navigate challenges and communicate the value of partner input. CONCLUSION: By using collaborative decision-making in the early stages and throughout the study, researchers built trust with partners so that when decisions were difficult to resolve, partners still felt listened to and that their input mattered. PATIENT OR PUBLIC CONTRIBUTION: Members of the PCORI Patient Engagement Advisory Panel in 2019-2020 provided input into the design of the study, including the research questions and approaches to data collection and analysis.

Understanding the Influence and Impact of Stakeholder Engagement in Patient-centered Outcomes Research: a Qualitative Study.

BACKGROUND: Engaging patients and other stakeholders as partners in research offers promise in improving the relevance and usefulness of research findings. OBJECTIVE: To explore the influence and impact of patient and other stakeholder engagement on the planning and conduct of comparative effectiveness research studies. DESIGN: Qualitative study with virtual, hour-long semi-structured interviews. PARTICIPANTS: Fifty-eight researchers and fifty-one partners from a diverse purposeful sample of fifty-eight studies funded by the Patient-Centered Outcomes Research Institute (PCORI). APPROACH: Content and thematic analysis of interview data. KEY RESULTS: Described as an integral, long-term part of the research process, engagement influenced all aspects of the design and execution of studies. Partner influence was also dynamic and iterative, taking different forms over the course of the study. Across studies, we identified 387 discrete examples of influence and classified each as one of five types of influence, derived inductively from the interview data: co-producing, redirecting, refining, confirming, and limited. Most projects exhibited multiple types of influence, with 50 researchers and 41 partners reporting two or more types of influence within a project. Of the 387 examples of stakeholder influence, 306 had at least one reported impact on the study. Such impacts included changes to reflect the needs and preferences of patients or clinicians, as well as impacts on study feasibility, study quality, engagement scope or quality, and study relevance. Both researchers and partners identified multiple types of impact within projects, with 42 researchers and 38 partners reporting two or more types within a project. Because of these observable impacts, researchers and partners described engagement as worthwhile. CONCLUSIONS: Findings provide insights for funders and institutions supporting engagement, measurement efforts, and clinical researchers aiming to conduct engaged research and observe similar influences and impacts in their own studies.

Researchers, patients, and other stakeholders' perspectives on challenges to and strategies for engagement.

BACKGROUND: There is growing interest in patient and stakeholder engagement in research, yet limited evidence about effective methods. Since 2012, the Patient-Centered Outcomes Research Institute (PCORI) has funded patient-centered comparative effectiveness research with a requirement for engaging patients and other stakeholders as research partners in study planning, conduct, and dissemination. This requirement, unique among large healthcare research funders in the US, provides an opportunity to learn about challenges encountered and specific strategies used by PCORI-funded study teams. The primary objective of this study is to describe -- from the perspective of PCORI investigators and research partners-the most common engagement challenges encountered in the first two years of the projects and promising strategies to prevent and overcome these challenges. METHODS: Descriptive information about investigators, partners, and their engagement was collected from investigators via annual (N = 235) and mid-year (N = 40) project progress reporting to PCORI, and from their partners (N = 260) via voluntary survey. Qualitative data were analyzed using content and thematic analyses. RESULTS: Investigators and partners most often described engagement challenges in three domains: (1) infrastructure to support engagement, (2) building relationships, and (3) maintaining relationships. Infrastructure challenges related to financial and human resources, including funding support and dedicated staff, identifying diverse groups of partners, and partners' logistical needs. Challenges for both building and maintaining relationships encompass a variety of aspects of authentic, positive interactions that facilitate mutual understanding, full participation, and genuine influence on the projects. Strategies to prevent or mitigate engagement challenges also corresponded overall to the same three domains. Both groups typically described strategies more generally, with applicability to a range of challenges rather than specific actions to address only particular challenges. CONCLUSION: Meaningful engagement of patients and other stakeholders comes with challenges, as does any innovation in the research process. The challenges and promising practices identified by these investigators and partners, related to engagement infrastructure and the building and maintenance of relationships, reveal actionable areas to improve engagement, including organizational policies and resources, training, new engagement models, and supporting engagement by viewing it as an investment in research uptake and impact.

What motivates patients and caregivers to engage in health research and how engagement affects their lives: Qualitative survey findings.

BACKGROUND: US research organizations increasingly are supporting patient and stakeholder engagement in health research with a goal of producing more useful, relevant and patient-centered evidence better aligned with real-world clinical needs. The Patient-Centered Outcomes Research Institute (PCORI) engages patients, family caregivers and other health-care stakeholders, including clinicians, payers and policymakers, as active partners in prioritizing, designing, conducting and disseminating research as a key strategy to produce useful evidence for health-care decision making. OBJECTIVE: To inform effective engagement practices and policies, we sought to understand what motivates patients and caregivers to engage as partners on PCORI-funded research projects and how such engagement changed their lives. METHODS: We conducted thematic analysis of open-ended survey responses from 255 patients, family caregivers and individuals from advocacy and community-based organizations who engaged as partners on 139 PCORI-funded research projects focusing on a range of health conditions. RESULTS: Partners' motivations for engaging in research were oriented primarily towards benefiting others, including a desire to improve patients' lives and to support effective health-care interventions. In addition to feeling they made a positive difference, many partners reported direct benefits from engagement, such as new relationships and improved health habits. DISCUSSION AND CONCLUSIONS: By identifying patient and caregiver motivations for engaging in research partnerships and what they get out of the experience, our study may help research teams and organizations attract partners and foster more satisfying and sustainable partnerships. Our findings also add to evidence that engagement benefits the people involved as partners, strengthening the case for more widespread engagement.

An informed public's views on reducing antibiotic overuse.

OBJECTIVE: To understand public attitudes about and recommendations to address antibiotic overuse by employing public deliberation (a method for eliciting informed input on value-laden issues). DATA SOURCES/STUDY SETTING: Participants in 24 Community Deliberation groups (CD; n = 263), four Citizens' Panel groups (CP; n = 96), and a control group (n = 348). Data were collected in 2012 in four U.S. STUDY DESIGN: Using mixed methods, we analyzed quantitative and qualitative data from a randomized control trial. DATA COLLECTION/EXTRACTION METHODS: Using pre/postdeliberation surveys, we compared CD and CP participant attitude changes regarding antibiotic use to the control group. We analyzed deliberation transcripts using qualitative techniques to provide context for survey results. PRINCIPAL FINDINGS: Compared to control group participants, CD and CP participants had a larger postdeliberation shift in attitudes toward support of government limits on when doctors can prescribe antibiotics. Participants described unawareness about antibiotic overuse and called for education. When discussing prescription limits, participants debated tensions between preserving patient/doctor autonomy and protecting society from antibiotic-related harms. Participants saw patient, physician, and government roles in antibiotic stewardship policies/programs. CONCLUSION: When informed about individual and social consequences of antibiotic overuse, patients may be more receptive to antibiotic prescription limits. Community-physician-government partnerships are needed to create solutions.

Patient Engagement In Research: Early Findings From The Patient-Centered Outcomes Research Institute.

Charged with ensuring that research produces useful evidence to inform health decisions, the Patient-Centered Outcomes Research Institute (PCORI) requires investigators to engage patients and other health care stakeholders, such as clinicians and payers, in the research process. Many PCORI studies result in articles published in peer-reviewed journals that detail research findings and engagement's role in research. To inform practices for engaging patients and others as research partners, we analyzed 126 articles that described engagement approaches and contributions to research. PCORI projects engaged patients and others as consultants and collaborators in determining the study design, selecting study outcomes, tailoring interventions to meet patients' needs and preferences, and enrolling participants. Many articles reported that engagement provided valuable contributions to research feasibility, acceptability, rigor, and relevance, while a few noted trade-offs of engagement. The findings suggest that engagement can support more relevant research through better alignment with patients' and clinicians' real-world needs and concerns.

Increasing the Use of Comparative Quality Information in Maternity Care: Results From a Randomized Controlled Trial.

This randomized controlled trial tested an intervention to increase uptake of hospital-level maternity care quality reports among 245 pregnant women in North Carolina (123 treatment; 122 control). The intervention included three enhancements to the quality report offered to the control: (a) biweekly text messages or e-mails directing women to the website, (b) videos and materials describing the relevance of quality measures to pregnant women's interests, and (c) tools to support discussions with clinicians. Compared with controls, intervention participants were significantly more likely to visit the website and report adopting behaviors to inform care, such as thinking through preferences, talking with their doctor, or creating a birth plan. Reports designed to put quality information into the larger context of what consumers want and need to know, along with targeted and timely communications, can increase consumer use of quality information and prompt them to talk with providers about care preferences and evidence-based practices.

Public Mistrust of the U.S. Health Care System's Profit Motives: Mixed-Methods Results from a Randomized Controlled Trial.

BACKGROUND: Decision makers are increasingly tasked with reducing health care costs, but the public may be mistrustful of these efforts. Public deliberation helps gather input on these types of issues by convening a group of diverse individuals to learn about and discuss values-based dilemmas. OBJECTIVE: To explore public perceptions of health care costs and how they intersect with medical mistrust. DESIGN AND PARTICIPANTS: This mixed-methods study analyzed data from a randomized controlled trial including four public deliberation groups (n = 96) and a control group (n = 348) comprising English-speaking adults aged 18 years and older. Data were collected in 2012 in four U.S. regions. APPROACH: We used data from four survey items to compare attitude shifts about costs among participants in deliberation groups to participants in the control group. We qualitatively analyzed deliberation transcripts to identify themes related to attitude shifts and to provide context for quantitative results about attitude shifts. KEY RESULTS: Deliberation participants were significantly more likely than control group participants to agree that doctors and patients should consider cost when making treatment decisions (ß = 0.59; p < 0.01) and that people should consider the effect on group premiums when making treatment decisions (ß = 0.48; p < 0.01). Qualitatively, participants mistrusted the health care system's profit motives (e.g., that systems prioritize making money over patient needs); however, after grappling with patient/doctor autonomy and learning about and examining their own views related to costs during the process of deliberation, they largely concluded that payers have the right to set some boundaries to curb costs. CONCLUSIONS: Individuals who are informed about costs may be receptive to boundaries that reduce societal health care costs, despite their mistrust of the health care system's profit motives, especially if decision makers communicate their rationale in a transparent manner. Future work should aim to develop transparent policies and practices that earn public trust.

Setting Boundaries: Public Views on Limiting Patient and Physician Autonomy in Health Care Decisions.

We obtained and qualitatively analyzed input from more than nine hundred citizens during seventy-six public deliberation sessions about patient and physician autonomy in decision making, setting health care boundaries, and the tensions among competing social values. Generally, participants resisted interference with the patient-physician relationship and believed strongly in the freedom of patient and physician to control individual medical decisions. However, during deliberation participants identified two situations where boundaries and regulations in health care were more acceptable: protecting people from harm and allocating limited resources. The core value of individual freedom was tempered in varying degrees by the values of concern for the greater good and fairness in allocating resources. Where tensions between values emerged, participants used different concepts-including accountability, transparency, trust, personal responsibility, and moral obligation-to navigate trade-offs. Fairly balancing the public's desire to protect individual freedom with their sense of responsibility for protecting the common good may be the key to developing acceptable, workable policies that promote evidence-based medical practice.

Engaging patients and consumers in research evidence: Applying the conceptual model of patient and family engagement.

OBJECTIVE: This essay discusses applying the Conceptual Framework for Patient and Family Engagement to partnerships with patients and consumers to increase their use of research evidence in healthcare decisions. The framework's foundational principles hold that engagement occurs on a continuum across all levels of healthcare-from direct care to policymaking-with patients and healthcare professionals working in full partnership and sharing responsibility for achieving a safe, high-quality, efficient, and patient-centered healthcare system. DISCUSSION: Research evidence can serve as a critical decision-making tool in partnerships between patients and health professionals. However, as the framework suggests, without patient and consumer engagement in the design, planning, interpretation, and dissemination of research findings, it is unlikely that the broader consumer population will find research evidence useful, much less use it, to guide their healthcare decisions. Understanding what factors influence patient and consumer engagement can lead to effective strategies that enable meaningful partnerships between patients and researchers. CONCLUSION: Understanding patient and consumer perspectives of research evidence is critical to engaging them in meaningful partnerships that produce actionable research findings that they can in turn use in partnership with health professionals to improve their own health and the healthcare system as a whole.

Understanding An Informed Public's Views On The Role Of Evidence In Making Health Care Decisions.

Policy makers and practitioners increasingly believe that medical evidence plays a critical role in improving care and health outcomes and lowering costs. However, public understanding of the role of evidence-based care may be different. Public deliberation is a process that convenes diverse citizens and has them learn about and consider ethical or values-based dilemmas and weigh alternative views. The Community Forum Deliberative Methods Demonstration project, sponsored by the Agency for Healthcare Research and Quality, obtained informed public views on the role of evidence in health care decisions through seventy-six deliberative groups involving 907 people overall, in the period August-November 2012. Although participants perceived evidence as being essential to high-quality care, they also believed that personal choice or clinical judgment could trump evidence. They viewed doctors as central figures in discussing evidence with patients and key arbiters of whether to follow evidence in individual cases. They found evidence of harm to individuals or the community to be more compelling than evidence of effectiveness. These findings indicate that increased public understanding of evidence can play an important role in advancing evidence-based care by helping create policies that better reflect the needs and values of the public.

Understanding Consumer Perceptions and Awareness of Hospital-Based Maternity Care Quality Measures.

OBJECTIVE: To explore factors that may influence use of comparative public reports for hospital maternity care. DATA SOURCES: Four focus groups conducted in 2013 with 41 women and preintervention survey data collected in 2014 to 2015 from 245 pregnant women in North Carolina. STUDY DESIGN: As part of a larger randomized controlled trial, we conducted qualitative formative research to develop an intervention that will be evaluated through pre- and postintervention surveys. DATA EXTRACTION METHODS: Analysis of focus group transcripts examined participants' perceptions of high-quality maternity care and the importance of different quality measures. Quantitative analysis included descriptive results of the preintervention survey and subgroup analyses to examine the impact of race, education, and being a first-time mom on outcomes. PRINCIPAL FINDINGS: When describing high-quality maternity care, participants focused on interactions with providers, including respect for preferences and communication. The importance of quality measures was influenced by the extent to which they focused on babies' health, were perceived as the hospital's responsibility, and were perceived as representing "standard care." At baseline, 28 percent of survey respondents had used quality information to choose a hospital. Survey respondents were more aware of some quality measures (e.g., breastfeeding support) than others (e.g., episiotomy rates). CONCLUSIONS: Public reporting efforts could help increase relevance of maternity care quality measures by creating measures that reflect women's concerns, clearly explaining the hospital's role in supporting quality care, and showing how available quality measures can inform decisions about childbirth.

Effects of organizational context on Lean implementation in five hospital systems.

BACKGROUND: Despite broad agreement among researchers about the value of examining how context shapes implementation of improvement programs and projects, limited attention has been paid to contextual effects on implementation of Lean. PURPOSE: To help reduce gaps in knowledge of effects of intraorganizational context, we researched Lean implementation initiatives in five organizations and examined 12 of their Lean rapid improvement projects. All projects aimed at improving clinical care delivery. METHODOLOGY/APPROACH: On the basis of the literature on Lean, innovation, and quality improvement, we developed a framework of factors likely to affect Lean implementation and outcomes. Drawing on the framework, we conducted semistructured interviews and applied qualitative codes to the transcribed interviews. Available documents, data, and observations supplemented the interviews. We constructed case studies of Lean implementation in each organization, compared implementation across organizations, and compared the 12 projects. FINDINGS: Intraorganizational characteristics affecting organization-wide Lean initiatives and often also shaping project outcomes included CEO commitment to Lean and active support for it, prior organizational capacity for quality improvement-based performance improvement, alignment of the Lean initiative with the organizational mission, dedication of resources and experts to Lean, staff training before and during projects, establishment of measurable and relevant project targets, planning of project sequences that enhance staff capabilities and commitment without overburdening them, and ensuring communication between project members and other affected staff. Dependence of projects on inputs of new information technology was a barrier to project success. Incremental implementation of Lean produced reported improvements in operational efficiency and occasionally in care quality. However, even under the relatively favorable circumstances prevailing in our study sites, incremental implementation did not readily change organizational culture. PRACTICE IMPLICATIONS: This study should alert researchers, managers, and teachers of management to ways that contexts shape Lean implementation and may affect other types of process redesign and quality improvement.

Creating Change in Health Care: Developing a Shared Understanding and Roadmap for Action.

The Patient and Family Engagement Framework and the Roadmap for Patient and Family Engagement in Healthcare Practice and Research are tools designed to create a shared understanding of what patient and family engagement is and how it can be translated into concrete action.

Effectiveness of public deliberation methods for gathering input on issues in healthcare: Results from a randomized trial.

UNLABELLED: Public deliberation elicits informed perspectives on complex issues that are values-laden and lack technical solutions. This Deliberative Methods Demonstration examined the effectiveness of public deliberation for obtaining informed public input regarding the role of medical evidence in U.S. healthcare. We conducted a 5-arm randomized controlled trial, assigning participants to one of four deliberative methods or to a reading materials only (RMO) control group. The four deliberative methods reflected important differences in implementation, including length of the deliberative process and mode of interaction. The project convened 76 groups between August and November 2012 in four U.S. LOCATIONS: Chicago, IL; Sacramento, CA; Silver Spring, MD; and Durham, NC, capturing a sociodemographically diverse sample with specific attention to ensuring inclusion of Hispanic, African-American, and elderly participants. Of 1774 people recruited, 75% participated: 961 took part in a deliberative method and 377 participants comprised the RMO control group. To assess effectiveness of the deliberative methods overall and of individual methods, we evaluated whether mean pre-post changes on a knowledge and attitude survey were statistically different from the RMO control using ANCOVA. In addition, we calculated mean scores capturing participant views of the impact and value of deliberation. Participating in deliberation increased participants' knowledge of evidence and comparative effectiveness research and shifted participants' attitudes regarding the role of evidence in decision-making. When comparing each deliberative method to the RMO control group, all four deliberative methods resulted in statistically significant change on at least one knowledge or attitude measure. These findings were underscored by self-reports that the experience affected participants' opinions. Public deliberation offers unique potential for those seeking informed input on complex, values-laden topics affecting broad public constituencies.

Deliberation: obtaining informed input from a diverse public.

OBJECTIVES: Health care decision makers require public input to incorporate diverse values into programs and policies. Deliberation, one method for obtaining input, seeks to apply inclusive principles wherein diverse groups provide perspectives to inform decisions. We evaluate whether participants of different racial, ethnic, and educational backgrounds show differences in the effect of deliberation and the value placed on deliberation participation. METHODS: We surveyed 907 participants before and after deliberation. Regression models examined associations between demographics and change in knowledge and attitudes, and perceived impact. RESULTS: Changes in knowledge about using medical evidence in decision-making were not associated with race, ethnicity, or education. Changes in attitudes were not associated with these characteristics with one exception. African American, Hispanic, and participants with lower educational attainment reported more perceived impact. CONCLUSION: Similar results across demographic groups suggest deliberation's promise for obtaining input from a diverse public to inform health programs and policies.

Patient and family engagement: a framework for understanding the elements and developing interventions and policies.

Patient and family engagement offers a promising pathway toward better-quality health care, more-efficient care, and improved population health. Since definitions of patient engagement and conceptions of how it works vary, we propose a framework. We first present the forms engagement can take, ranging from consultation to partnership. We discuss the levels at which patient engagement can occur across the health care system, from the direct care setting to incorporating patient engagement into organizational design, governance, and policy making. We also discuss the factors that influence whether and to what extent engagement occurs. We explore the implications of our multidimensional framework for the development of interventions and policies that support patient and family engagement, and we offer a research agenda to investigate how such engagement leads to improved outcomes.