Patient Engagement Activities and Infrastructure Among US Veterans Affairs National Research Networks.

Patient Engagement in Research and Innovation: A New Framework

T welve years ago my husband and I were happily content with the challenges and rewards of tending our fourthgeneration dryland wheat farm. I was also teaching English reading at the local community college. Then we were asked to be part of a rural healthcare research team—to participate not as study subjects but as community-based researchers. At that time, the concept of engaging patients in the research continuum and as co-researchers was considered experimental and, by some hardcore scientists, a bit quaint. Twelve years ago, I knew little about patient engagement and nothing about medical research. If asked, I would have said I was an engaged patient, informed about my own health. I stayed abreast of research as it was presented in the popular media. I maintained an active relationship with my primary care provider, and I felt empowered to ask hard questions, advocate for myself or my family, and demand some control over my health care decisions and actions. But, bottom line, I was and am a patient; I am not a researcher. Yet, here I am, commenting on today’s research on patient engagement. Engaging patients as co-researchers—co-creators, coinvestigators, partner advisors—is crucial to the successful translation of medical discoveries into everyday clinical practice. When I first had an opportunity to ask questions that matter to my community, to ensure that the participatory research process met the needs and personality of my small town, to improve the health of my community, I was a bit skeptical...and intrigued. I joined the Community Advisory Council of the High Plains Research Network (HPRN C.A.C.), created to complement the practice-engaged research of our university-based research network. The HPRN was collaborating with doctors’ offices and clinicians in rural and frontier Colorado, but something was missing. Research was happening, but the questions were not relevant to primary care practice or their patients, and the answers were not aligned with the way we in the community lived our daily lives. The missing piece was the patient voice and the real-life context that it brought to the research. Without this context, the research lacked local relevance and was, consequently, low impact. This is where I entered the world of patient-engaged research. For the past 12 years, I, along with a group of about 18 other community members, have straddled the fence between the university research world and our everyday lives in rural eastern Colorado. The High Plains Research Network is not alone. Patient, stakeholder, community member, and practice engagement has taken off and is now the norm in many academic settings. The National Institutes of Health’s Clinical Translational Science Awards encourage and support patient-engaged participatory research. The Patient-Centered Outcomes Research Institute (PCORI) requires active patient and stakeholder engagement in the research it funds. Patient engagement is a broad continuum of activities and participation, from fully engaged community-based participatory research (CBPR) to the less engaged individual patient representative sitting at an annual board meeting. While there is a robust body of literature on CBPR, less has been studied and disseminated on the rest of patient engagement. The two terms are not interchangeable. CBPR is one type of patient engagement. Patient and stakeholder engagement in patient-centered outcomes research (PCOR) falls along a broad continuum of engagement and participation. Common key elements are found across the continuum; however, the rest of patient engagement includes a wider variety of methods, locations, and research topics. The work of Forsythe and colleagues signals an important milestone in the progress toward more genuine patientengaged research. They studied the first group of PCORI pilot awardees, measuring patient engagement efforts actually occurring in the projects. They gathered data on the level of engagement, length and nature of engagement, facilitators and barriers to engagement, and how engagement impacted the research. This report provides an early understanding of the range of patient engagement strategies, activities, and lessons in PCOR. Their report is a starting point for patient engagement in the PCORI research portfolio and confirms key tenets that the HPRN C.A.C have found critical for success. Several key components of patient engagement are described. First, patients and other stakeholders can and should be engaged early and often. Successful engagement is not a JGIM

Plain English summaryPatient engagement (or patient and public involvement) in health research is becoming a requirement for many health research funders, yet many researchers have little or no experience in engaging patients as partners as opposed to research subjects. Additionally, many patients have no experience providing input on the research design or acting as a decision-making partner on a research team. Several potential risks exist when patient engagement is done poorly, despite best intentions. Some of these risks are that: (1) patients’ involvement is merely tokenism (patients are involved but their suggestions have little influence on how research is conducted); (2) engaged patients do not represent the diversity of people affected by the research; and, (3) research outcomes lack relevance to patients’ lives and experiences.Qualitative health research (the collection and systematic analysis of non-quantitative data about peoples’ experiences of health or illness and the healthcare system) offers several approaches that can help to mitigate these risks. Several qualitative health research methods, when done well, can help research teams to: (1) accurately incorporate patients’ perspectives and experiences into the design and conduct of research; (2) engage diverse patient perspectives; and, (3) treat patients as equal and ongoing partners on the research team.This commentary presents several established qualitative health research methods that are relevant to patient engagement in research. The hope is that this paper will inspire readers to seek more information about qualitative health research, and consider how its established methods may help improve the quality and ethical conduct of patient engagement for health research.BackgroundResearch funders in several countries have posited a new vision for research that involves patients and the public as co-applicants for the funding, and as collaborative partners in decision-making at various stages and/or throughout the research process. Patient engagement (or patient and public involvement) in health research is presented as a more democratic approach that leads to research that is relevant to the lives of the people affected by its outcomes. What is missing from the recent proliferation of resources and publications detailing the practical aspects of patient engagement is a recognition of how existing research methods can inform patient engagement initiatives. Qualitative health research, for example, has established methods of collecting and analyzing non-quantitative data about individuals’ and communities’ lived experiences with health, illness and/or the healthcare system. Included in the paradigm of qualitative health research is participatory health research, which offers approaches to partnering with individuals and communities to design and conduct research that addresses their needs and priorities.DiscussionThe purpose of this commentary is to explore how qualitative health research methods can inform and support meaningful engagement with patients as partners. Specifically, this paper addresses issues of: rigour (how can patient engagement in research be done well?); representation (are the right patients being engaged?); and, reflexivity (is engagement being done in ways that are meaningful, ethical and equitable?). Various qualitative research methods are presented to increase the rigour found within patient engagement. Approaches to engage more diverse patient perspectives are presented to improve representation beyond the common practice of engaging only one or two patients. Reflexivity, or the practice of identifying and articulating how research processes and outcomes are constructed by the respective personal and professional experiences of researchers and patients, is presented to support the development of authentic, sustainable, equitable and meaningful engagement of patients as partners in health research.ConclusionsResearchers will need to engage patients as stakeholders in order to satisfy the overlapping mandate in health policy, care and research for engaging patients as partners in decision-making. This paper presents several suggestions to ground patient engagement approaches in established research designs and methods.

Plain English summaryPatient engagement in research is an emerging approach that involves active and meaningful collaboration between researchers and patients throughout all phases of a project, including planning, data collection and analysis, and sharing of findings. To better understand the core features (elements) that underlie patient engagement, it is useful to have a look at models and frameworks that guide its conduct. Therefore, this manuscript aims to present a protocol for a scoping review of models and frameworks of patient engagement in health services research. Methods: Our protocol design is based on an established framework for conducting scoping reviews. We will identify relevant models and frameworks through systematic searches of electronic databases, websites, reference lists of included articles, and correspondence with colleagues and experts. We will include published and unpublished articles that present models and frameworks of patient engagement in health services research and exclude those not in English or unavailable as full texts. Two reviewers will independently review abstracts and full texts of identified articles for inclusion and extract relevant data; a third reviewer will resolve discrepancies. Our primary objective is to count and describe elements of patient engagement that overlap (present in 2 or more) and diverge among included models and frameworks. Discussion: We hope this review will raise awareness of existing models and frameworks of patient engagement in health services research. Further, by identifying elements that overlap and diverge between models and frameworks, this review will contribute to a clearer understanding of what patient engagement in research is and/or could be.Background: Patients can bring an expert voice to healthcare research through their lived experience of receiving healthcare services. Patient engagement in research is an emerging approach that challenges researchers to acknowledge and utilize this expertise through meaningful and active collaboration with patients throughout the research process. In order to facilitate a clearer understanding of the core elements that underlie patient engagement, it is useful to examine existing models and frameworks that guide its conduct. Therefore, the aim of this manuscript is to present a protocol for a scoping review of models and frameworks of patient engagement in health services research. Methods: Drawing on Arksey and O’Malley’s and Levac et al.’s framework for scoping reviews, we designed our protocol to identify relevant a) published articles through systematic searches of 7 electronic databases and snowball sampling and b) unpublished articles through systematic searches of databases and websites and snowball sampling. We will include published and unpublished models and frameworks of patient engagement in health services research and exclude those not in English or unavailable as full texts. Two reviewers will independently screen the abstracts and full texts of identified articles for inclusion and extract relevant data; a third reviewer will resolve disagreements. We will conduct a descriptive analysis of the characteristics (i.e., elements underlying patient engagement and those related to the study authors, publication, and model/framework) of included articles and a narrative analysis of the data concerning elements of the model or framework. Our primary objective is to count and describe elements of patient engagement that overlap (present in ≥ 2) and diverge (present in < 2) among identified models and frameworks. Discussion: Through identification of elements that overlap and diverge between existing models and frameworks, this review will provide a starting point for the critical reflection on our collective understanding of what patient engagement in health services research is and/or could be. Ultimately, we hope that the findings of this review raise awareness of existing models and frameworks and shed light on some of the complexity of conducting patient engaged research through identification of key elements that shape this approach.

Plain English summaryPatient engagement is an opportunity for people with experience of a health-related issue to contribute to research on that issue. The Canadian Strategy for Patient-Oriented Research (SPOR) highlights patient engagement as an important part of health research. Patient engagement, however, is a new concept for many researchers and research ethics boards, and it can be difficult to understand the differences between patient engagement activities and research activities. Focus groups are one example of how research and patient engagement activities are often confused.We distinguish these two types of activities by using different terms for each. We use focus groups to refer to research activities, and discussion groups to refer to patient engagement activities. In focus groups, researchers collect data by speaking with a group of research subjects about their experiences. Researchers use this information to answer research questions and share their findings in academic journals and gatherings. In patient engagement, discussion groups are a way for patients to help plan research projects. Their contributions are not treated as research data, but instead they help make decisions that shape the research process. We have found that using different language to refer to each type of activity has led to improved clarity in research planning and research ethics submissions.BackgroundIn patient-oriented research (POR), focus groups can be used as a method in both qualitative research and in patient engagement. Canadian health systems researchers and research ethics boards (REBs), however, are often unaware of the key differences to consider when using focus groups for these two distinct purposes. Furthermore, no one has clearly established how using focus groups for these two purposes should be differentiated in the context of Canada’s Strategy for Patient-Oriented Research (SPOR), which emphasizes appropriate patient engagement as a fundamental component of POR.BodyResearchers and staff in the Maritime SPOR SUPPORT Unit refer to focus groups in patient engagement as discussion groups for clarity, and have developed internal guidelines to encourage their appropriate use. In this paper, the guidelines comparing and contrasting the design and conduct of focus groups and of discussion groups is described, including: the theoretical framework for each; the need for research ethics board review approval; identifying participants; collecting and analyzing data; ensuring rigour; and disseminating results.ConclusionThe MSSU guidelines address an important and current methodological challenge in patient-oriented research, which will benefit Canadian and international health systems researchers, patients, and institutional REBs.

Strategies to engage patients to improve and enhance research and clinical care are increasingly being implemented in the United States, yet little is known about best practices for or the impacts of meaningful patient engagement. We describe and reflect on our patient stakeholder groups, engagement framework, experiences, and lessons learned in engaging patients in research, from generating proposal ideas to disseminating findings. The ADVANCE (Accelerating Data Value Across a National Community Health Center Network) clinical data research network is the nation's largest clinical dataset on the safety net, with outpatient clinical data from 122 health systems (1109 clinics) in 23 states. Patients stakeholders codeveloped the ADVANCE engagement framework and its implementation in partnership with network leaders. In phase I of ADVANCE, patients were involved with designing studies (input on primary outcome measures and methods) and usability testing (of the patient portal). In phase II, the network is prioritizing research training, dissemination opportunities, an "ambassador" program to pair more experienced patient stakeholders with those less experienced, and evaluation of engagement activities and impacts. The ADVANCE framework for patient engagement has successfully involved a diverse group of patients in the design, implementation, and interpretation of comparative effectiveness research. Our experience and framework can be used by other organizations and research networks to support patient engagement activities.

The COVID-19 pandemic has had a devastating impact on healthcare systems and care delivery, changing the context for patient and family engagement activities. Given the critical contribution of such activities in achieving health system quality goals, we undertook to address the question: What is known about work that has been done on patient engagement activities during the pandemic? To examine peer-reviewed and grey literature to identify the range of patient engagement activities, broadly defined (inclusive of engagement to support clinical care to partnerships in decision-making), occurring within health systems internationally during the first six months of the COVID-19 pandemic, as well as key barriers and facilitators for sustaining patient engagement activities during the pandemic. The following databases were searched: Medline, Embase and LitCOVID; a search for grey literature focused on the websites of professional organizations. Articles were required to be specific to COVID-19, describe patient engagement activities, involve a healthcare organization and be published from March 2020 to September 2020. Data were extracted and managed using Microsoft Excel. A content analysis of findings was conducted. Twenty-nine articles were included. Few examples of more genuine partnership with patients were identified (such as co-design and organizational level decision making); most activities related to clinical level interactions (e.g. virtual consultations, remote appointments, family visits using technology and community outreach). Technology was leveraged in almost all reported studies to interact or connect with patients and families. Five main descriptive categories were identified: (1) Engagement through Virtual Care; (2) Engagement through Other Technology; (3) Engagement for Service Improvements/ Recommendations; (4) Factors Impacting Patient Engagement; and (5) Lessons Learned though Patient Engagement. Evidence of how healthcare systems and organizations stayed connected to patients and families during the pandemic was identified; the majority of activities involved direct care consultations via technology. Since this review was conducted over the first six months of the pandemic, more work is needed to unpack the spectrum of patient engagement activities, including how they may evolve over time and to explore the barriers and facilitators for sustaining activities during major disruptions like pandemics.

Action brief: Patient engagement and activation: A health reform imperative and improvement opportunity for nursing

ObjectiveTo shorten the Patient Engagement In Research Scale (PEIRS) to its most essential items and evaluate its measurement properties for assessing the degree of patients’ and family caregivers’ meaningful engagement as partners in research projects.MethodsA prospective cross‐sectional web‐based survey in Canada and the USA, and also paper‐based in Canada. Participants were patients or family caregivers who had engaged in research projects within the last 3 years, were ≥17 years old, and communicated in English. Extensive psychometric analyses were conducted.Results119 participants: 99 from Canada, 74 female, 51 aged 17‐35 years and 50 aged 36‐65 years, 60 had post‐secondary education, and 74 were Caucasian/white. The original 37‐item PEIRS was shortened to 22 items (PEIRS‐22), mainly because of low inter‐item correlations. PEIRS‐22 had a single dominant construct that accounted for 55% of explained variance. Analysis of PEIRS‐22 scores revealed the following: (1) acceptable floor and ceiling effects (<15%), (2) internal consistency (ordinal alpha = 0.96), (3) structural validity by fit to a Rasch measurement model, (4) construct validity by moderate correlations with the Public and Patient Engagement Evaluation Tool, (5) good test‐retest reliability (ICC2,1 = 0.86) and (6) interpretability demonstrated by significant differences among PEIRS‐22 scores across three levels of global meaningful engagement in research.ConclusionsThe shortened PEIRS is valid and reliable for assessing the degree of meaningful patient and family caregiver engagement in research. It enables standardized assessment of engagement in research across various contexts.Patient or public contributionA researcher‐initiated collaboration, patient partners contributed from study conception to manuscript write‐up.

BackgroundThe COVID-19 pandemic has had a devastating impact on healthcare systems and care delivery, changing the context for patient and family engagement activities. Given the critical contribution of such activities in achieving health system quality goals, we undertook to address the question: What is known about work that has been done on patient engagement activities during the pandemic?ObjectiveTo examine peer-reviewed and grey literature to identify the range of patient engagement activities, broadly defined (inclusive of engagement to support clinical care to partnerships in decision-making), occurring within health systems internationally during the first six months of the COVID-19 pandemic, as well as key barriers and facilitators for sustaining patient engagement activities during the pandemic.MethodsThe following databases were searched: Medline, Embase and LitCOVID; a search for grey literature focused on the websites of professional organizations. Articles were required to be specific to COVID-19, describe patient engagement activities, involve a healthcare organization and be published from March 2020 to September 2020. Data were extracted and managed using Microsoft Excel. A content analysis of findings was conducted.ResultsTwenty-nine articles were included. Few examples of more genuine partnership with patients were identified (such as co-design and organizational level decision making); most activities related to clinical level interactions (e.g. virtual consultations, remote appointments, family visits using technology and community outreach). Technology was leveraged in almost all reported studies to interact or connect with patients and families. Five main descriptive categories were identified: (1) Engagement through Virtual Care; (2) Engagement through Other Technology; (3) Engagement for Service Improvements/ Recommendations; (4) Factors Impacting Patient Engagement; and (5) Lessons Learned though Patient Engagement.ConclusionsEvidence of how healthcare systems and organizations stayed connected to patients and families during the pandemic was identified; the majority of activities involved direct care consultations via technology. Since this review was conducted over the first six months of the pandemic, more work is needed to unpack the spectrum of patient engagement activities, including how they may evolve over time and to explore the barriers and facilitators for sustaining activities during major disruptions like pandemics.

Patient and Family Engagement in Research in Era 3

BackgroundPatient and Public Involvement (PPI) in health research is gaining increased attention and acceptance worldwide. Reliable measurements are crucial to accurately assess, monitor, and evaluate patient involvement efforts in research. The Patient Engagement in Research Scale (PEIRS-22) measures meaningful patient and family caregiver engagement in research. This study focuses on three primary objectives: (1) translation of the PEIRS-22 from English to Danish, followed by linguistic validation and cultural adaptation; (2) assessing the applicability of the Danish PEIRS-22; and (3) focus group interviews to explore the user experiences of PPI.MethodsA three-phase multi-method study was conducted. In phase one, the PEIRS-22 was translated, linguistically validated and culturally adapted to Danish. In phase two individuals from three distinct patient cancer advisory boards responded to the Danish version of PEIRS-22 to assess its applicability. Three focus group interviews were conducted in phase three, involving individuals from three patient cancer advisory boards.ResultsThe translation process resulted in a Danish version of PEIRS-22, conceptually and culturally equivalent to the English version. Overall, among individuals of the three advisory boards (n = 15) the applicability was found to be satisfactory, with no missing data and all items completed. The total PEIRS-22 score among the three advisory boards was 85.2 out of a possible 100, with higher scores indicating greater meaningful involvement. A nested sample of the three patient cancer advisory boards (n = 9) participated in focus group interviews. The analysis yielded four themes: (1) The Danish PEIRS-22 captured the intended cultural meaning and contributed to self-reflection, (2) Internal motivation is a driver for involvement (3), Involvement brought a personal sense of empowerment and (4) Meaningful involvement collaborations are fostered by a trustful atmosphere.ConclusionsThe PEIRS-22 questionnaire has been translated, linguistically validated, and culturally adapted into Danish. We propose that the PEIRS-22 is now ready for use in Danish populations. This study provides a Danish version of the questionnaire that can be used to develop patient-centred practices and foster meaningful involvement and collaborations between patients and researchers in the field of cancer research in Denmark. Personal benefits of participating in PPI can vary, and we recommend using PEIRS-22 in conjunction with a qualitative approach to better explore perspectives on meaningful involvement.Trial registrationThe study was registered prospectively on October 22, 2022, by the Danish Data Protection Agency (jr. nr. P-2022–528).

Plain English summaryRetinoblastoma is a rare eye cancer that occurs in one or both eyes of infants and young children as a result of errors in the RB1 gene. There are approximately 2000 retinoblastoma survivors in Canada. Those with the heritable form of the disease are at risk of passing the gene to the next generation and developing a second cancer. Many retinoblastoma survivors and families therefore interact with the healthcare system throughout their lives.The retinoblastoma community has a longstanding history of engaging patients in research, however without any formal process. The literature establishes benefits to patient engagement such as research results which are more applicable, credible, and transparent. Building on the established interest among stakeholders, the Canadian Retinoblastoma Research Advisory Board (CRRAB) was established in 2016 to foster sustainable and meaningful collaboration between patients (survivors and family members), advocacy groups, healthcare professionals, and researchers in the retinoblastoma community.The aim of this study was to evaluate the utility of CRRAB in fostering patient engagement in research. Members of CRRAB were surveyed to uncover their attitudes towards and experience with patient engagement in research. Participants perceived CRRAB to provide diverse and accessible opportunities for patient engagement in research and perceived their participation to have a meaningful impact. The results suggest that CRRAB promotes patient engagement in retinoblastoma research, and provides direction to sustain and enhance future patient engagement.BackgroundThe Canadian Retinoblastoma Research Advisory Board (CRRAB) is a multidisciplinary group, including patients (survivors and family members), advocacy groups, healthcare professionals, and researchers, which aims to establish and sustain patient engagement in retinoblastoma research. The purpose of this study was to describe the development of CRRAB and to uncover members’ understanding of and attitudes towards patient engagement in research. As well, to determine their level of engagement.MethodsRetinoblastoma patients, healthcare professionals, and researchers provided leadership to co-develop CRRAB. CRRAB members were surveyed by pre- and post-test questionnaire at the 2016 Annual General Meeting to assess experience with, understanding of, and attitudes towards patient engagement in research. A second questionnaire was administered before the 2017 CRRAB meeting to assess awareness and perceived impact of CRRAB activities, and individual engagement in research. Data were analyzed by descriptive statistics and paired t-test (for pre/post-test). Thematic analysis of chart board discussions at both meetings revealed the joint goals of CRRAB and reasons for and barriers to patient engagement.ResultsIn 2016, 21 individuals participated and self-identified as patients (11, 52%), healthcare professionals (6, 29%), and/or researchers (7, 33%) (participants could overlap stakeholder groups). Overall, participants believed that research is relevant to all stakeholders and that patients can have meaningful impact on research. In 2017, 35 individuals participated and identified as patients (21, 60%), healthcare professionals (9, 26%), and/or researchers (8, 23%). 94% of participants were aware of CRRAB initiatives and 67% had participated in at least one over the previous year. Participants perceived that CRRAB provides diverse opportunities and increases accessibility for patient engagement in research, and perceived patient engagement to have meaningful impact on retinoblastoma research. Chart board discussions revealed that participants wanted to be part of CRRAB to increase knowledge, support innovation and patient engagement, and be part of a community. Members most commonly faced barriers including time and cost restraints.ConclusionsThe results of this study suggest that CRRAB has supported the engagement needs of patients affected by retinoblastoma, and has provided an opportunity for engaging patients in retinoblastoma research. CRRAB will continue to be used as a framework for patient engagement, with improvements based on participant feedback.

Better Together: Launching and Nurturing a Community Stakeholder Committee to Enhance Care and Research for Asthma and COPD

Background: Ease of use, efficacy, and favorable side effect profile of current Hepatitis C (HepC) treatments has increased utilization. However, given the price-tag of newer regimens there is an increased focus on ensuring patients receive the most appropriate regimen for the shortest duration to achieve sustained viral response (SVR). Central to achieving optimal patient outcomes is strong provider and patient engagement that addresses social, medical and financial barriers.Objectives: Describe patient and provider engagement outcomes for patients receiving HepC treatmentMethods: Patient and provider engagement activities were summarized for patients who initiated HepC treatment with Fairview Specialty Pharmacy (FSP) between 8/1/2016 and 7/31/2017. Patients who transferred to another specialty pharmacy were excluded. Outcomes related to provider engagement include: rate of shortest appropriate duration of therapy for ledipasvir/sofosbuvir, acceptance of recommendations, and viral response data obtainment. Outcomes related to patient engagement include: HepC treatment completion, SVR rates, patient satisfaction. Discontinuation was determined by an appropriate number of fills and verification that patient completed therapy. Patient satisfaction was reported from the 2017 therapy management patient satisfaction survey.Results: During the 12-months, 1212 patients initiated HepC treatment. The most common medication regimen was ledipasvir/sofosbuvir (N = 540), of which 49% were prescribed a duration of 8 weeks, and 83% of the patients that were clinically eligible for ledipasvir/sofosbuvir 8 weeks received the cost-saving duration. Before therapy initiation, our pharmacists performed 265 clinical interventions addressing hepatitis C regimens or drug interactions, and 86% were accepted by the prescriber. Additionally, 93 clinical interventions were performed during therapy and 95% were accepted. As a result of patient engagement activities, 97% (N = 1181) completed therapy and FSP was able to obtain virologic response information for 70% (N = 827) of patients that completed therapy and confirmed that 96% of assessed patients (N = 790) achieved an SVR. Overall, 94% of patients were satisfied with the quality of care from the HepC therapy management clinician.Conclusions: Patient engagement is critical to ensure patients are ready to initiate and complete therapy. Provider engagement allows for better collaboration on appropriate therapy choice and sharing of clinical outcomes to measure treatment success. Both components ensure a high rate of treatment success.