Meaningful Patient Engagement Research Articles

Engaging nursing home residents in clinical research: insights from a patient advisory board, a patient advocate, and a study team

BackgroundPatient and Public Involvement (PPI) is increasingly recognized as an essential aspect of clinical research, particularly for ensuring relevancy and impact of research to those most affected. This study addresses the gap in involving older patients, particularly nursing home residents, in the research process by exploring motivations, expectations, and experiences of nursing home residents in Bremen, Germany, involved in PPI for developing a clinical trial on polypharmacy.MethodsTwo Patient Advisory Boards (PABs) were established in nursing homes as part of the INVOLVE-Clin project. A Patient Advocate (PA) facilitated communication between nursing home residents and researchers. A qualitative case study approach was employed, involving semi-structured interviews and group discussions with nursing home residents and researchers. Data was analyzed using structured qualitative content analysis.ResultsThe study found varied motivations and expectations between nursing home residents and researchers. Nursing home residents valued the social interaction and the opportunity to voice their health concerns, while researchers aimed to incorporate patients’ perspectives into study design. The PA was considered crucial in facilitating communication between nursing home residents and researchers. Challenges included the complexity of the study topic and the need for methodological adjustments to suit nursing home residents´ cognitive abilities. Generally, PAB participation was experienced to provide mental stimulation and increased confidence among nursing home residents in discussing their medication management. The PAB’s influence led to the decision not to conduct a polypharmacy study.DiscussionThe findings underscore the importance of flexible approaches to PPI, particularly when involving older nursing home residents. Methodological adjustments, such as tailoring content and structure of PABs, and the inclusion of additional boards for diverse perspectives, are vital for effective involvement. The study also highlights the need for ongoing innovation in PPI methods to ensure meaningful engagement of older patients in clinical research.ConclusionThis study contributes essential insights into the practical implementation of PPI with nursing home residents, highlighting the need for patient-centric approaches that recognize their unique challenges and contributions. These findings are critical for shaping scientifically robust but also socially relevant and impactful research, especially in an aging society.

Measuring and Demonstrating the Value of Patient Engagement Across the Medicines Lifecycle: A Patient Engagement Impact Measurement Framework.

As the pharmaceutical industry advances towards more patient-focused product development, it is well recognized that meaningful patient engagement is required for the authentic patient voice to inform research and regulatory decisions. However, for this to happen systematically and consistently across the industry, there is still a need to evaluate and communicate the value of patient engagement to all stakeholders. Evaluating engagement also informs process improvement, elevating the value further. We describe the development of a conceptual, yet practical, framework for measuring the impact of engagement to achieve this. The framework depicts how metrics can be used to capture and assess the inputs, outputs, and value of patient engagement across the medicines lifecycle. Although conceived in the context of systems and processes within one company, Novartis, the framework was co-created with patient advisors and designed to be both patient-relevant and adaptable for any pharmaceutical organization. The adoption and evolution of the framework will help to demonstrate the value-to patients, healthcare systems, and businesses-of integrating patient engagement into core activities across the medicines lifecycle. We encourage the pharmaceutical industry to apply impact measurement to build a robust evidence base, through measuring, publishing, and communicating the value of patient engagement.

Meaningful patient and public engagement in dissemination-embedding co-production in dementia research.

Patient and Public Involvement and Engagement (PPIE) is still underutilised in both dementia research and corresponding dissemination activities. To describe the methods, format, and lessons learned in co-creating and co-producing a dissemination strategy for a research project focused on establishing patient-centred outcome measures into routine palliative community care for persons living with dementia (PLWD) and their informal carers. A participatory, hybrid-format workshop was conducted to co-create the dissemination strategy with a PPIE group. A video presentation of findings and a list of prompts shared prior to the workshop were used to elicit views on dissemination strategies and knowledge translation. The workshop was followed up with a survey to consolidate the dissemination strategy. Workshop minutes and survey responses were analysed using qualitative thematic analysis. 22 participants from our diverse PPIE group attended the workshop. Two major themes emerged: (a) Knowledge translation: building bridges between research and practise, and (b) Collaboration and dissemination: everyone's voice is needed. Participants suggested critical changes to dissemination methods and materials. Successful knowledge translation depends on a strong evidence base. For this, materials need to be tailored to specific audiences. Everyone's voice needs to be integrated through co-production in dissemination activities by PPIE members to influence societal change. Tailored dissemination activities within a dissemination strategy were co-created spanning all phases of the research cycle. Informing and educating the public and policymakers about the needs of PLWD relies on disseminating and fostering knowledge translation throughout all phases of the research cycle.

Fostering nurse-patient relationships in palliative care: An integrative review with narrative synthesis.

Nurse-patient relationships are an integral component of person-centred palliative care. Greater understanding of how nurse-patient relationships are fostered and perceived by patients and nurses can be used to inform nursing practice. To systematically identify and synthesise how nurse-patient relationships are fostered in specialist inpatient palliative care settings, and how nurse-patient relationships were perceived by patients and nurses. Integrative review with narrative synthesis. The review protocol was registered with PROSPERO (CRD42022336148, updated April, 2023). Five electronic databases (PubMed, CINAHL Complete, Medline, Web of Science and PsycINFO) were searched for articles published from their inception to December 2023. Studies were included if they (i) examined nurse and/or patient perspectives and experiences of nurse-patient relationships in specialist inpatient palliative care, (ii) were published in English in a (iii) peer-reviewed journal. The Mixed Methods Appraisal Tool was used to evaluate study quality. Data were synthesised using narrative synthesis. Thirty-four papers from 31 studies were included in this review. Studies were mostly qualitative and were of high methodological quality. Four themes were identified: (a) creating connections; (b) fostering meaningful patient engagement; (c) negotiating choices and (d) building trust. Nurses and patients are invested in the nurse-patient relationship, benefitting when it is positive, therapeutic and both parties are valued partners in the care. Key elements of fostering the nurse-patient relationship in palliative care were revealed, however, the dominance of the nurses' perspectives signifies that the nature and impact of these relationships may not be well understood.

Impact of Interventions on Medication Adherence in Patients With Coexisting Diabetes and Hypertension.

The coexistence of diabetes and hypertension is prevalent due to shared risk factors. Pharmacological treatment has been reported to be effective in managing both conditions. However, treatment effectiveness depends on the extent to which a patient adheres to their treatment. Poor adherence to long-term treatment for chronic diseases is a growing global problem of significant magnitude. Several interventions have been developed to help improve medication adherence in patients with coexisting diabetes and hypertension. This review aimed to determine the characteristics of these interventions and their impact on medication adherence. A systematic review of the literature was conducted using the PRISMA guidelines and registered in the PROSPERO International Registry of Systematic Reviews. Studies were searched in the databases CINAHL, Embase and Medline to identify relevant articles published during 2012-2023. The search concepts included 'medication adherence', 'hypertension', 'diabetes' and 'intervention'. Studies were included if they were in English and evaluated the impact of an intervention aimed at promoting adherence to medications for both diabetes and hypertension. Seven studies met the inclusion criteria, with five demonstrating a statistically significant improvement in medication adherence. Of the five studies that improved medication adherence, four were multifaceted and one was a single-component intervention. All successful interventions addressed at least two factors influencing non-adherence. Patient education was the foundation of most of the successful interventions, supported by other strategies, such as follow-ups and reminders. Multifaceted interventions that also included patient education had a positive impact on medication adherence in patients with coexisting diabetes and hypertension. Improving adherence in patients with coexisting diabetes and hypertension requires a multipronged approach that considers the range of factors impacting medication-taking. This systematic review provides comprehensive insights into the benefits of patient-centred approaches in intervention development and strengthening. Such patient involvement ensures that medication adherence interventions are more relevant, acceptable and effective, ultimately leading to better health outcomes and more meaningful patient engagement in healthcare research.

Typology of solutions addressing diagnostic disparities: gaps and opportunities.

Diagnostic disparities are preventable differences in diagnostic errors or opportunities to achieve diagnostic excellence. There is a need to summarize solutions with explicit considerations for addressing diagnostic disparities. We aimed to describe potential solutions to diagnostic disparities, organize them into an action-oriented typology with illustrative examples, and characterize these solutions to identify gaps for their further development. During four human-centered design workshops composed of diverse expertise, participants ideated and clarified potential solutions to diagnostic disparities and were supported by environmental literature scan inputs. Nineteen individual semi-structured interviews with workshop participants validated identified solution examples and solution type characterizations, refining the typology. Our typology organizes 21 various types of potential diagnostic disparities solutions into four primary expertise categories needed for implementation: healthcare systems' internal expertise, educator-, multidisciplinary patient safety researcher-, and health IT-expertise. We provide descriptions of potential solution types ideated as focused on disparities and compare those to existing examples. Six types were characterized as having diagnostic-disparity-focused examples, five as having diagnostic-focused examples, and 10 as only having general healthcare examples. Only three solution types had widespread implementation. Twelve had implementation on limited scope, and six were mostly hypothetical. We describe gaps that inform the progress needed for each of the suggested solution types to specifically address diagnostic disparities and be suitable for the implementation in routine practice. Numerous opportunities exist to tailor existing solutions and promote their implementation. Likely enablers include new perspectives, more evidence, multidisciplinary collaborations, system redesign, meaningful patient engagement, and action-oriented coalitions.

Experiences and lessons learned from a patient-engagement service established by a national research consortium in the U.S. Veterans Health Administration.

Meaningful engagement of patients in the research process has increased over the past 20 years. Few accounts are available of engagement infrastructure and processes used by large research organizations. The Pain/Opioid Consortium of Research (Consortium) is a U.S. Department of Veterans Affairs (VA) research network that provides infrastructure to accelerate health research and implementation of evidence-based health care. The Consortium's key activities include facilitating Veteran-engaged research and building community between Veterans and VA researchers. This report sought to describe experiences and lessons learned from the first 3 years of a national research engagement service, featuring a Veteran Engagement (VE) Panel, established by the Consortium. We gathered authors' experiences to describe development and operation of the Consortium's VE Panel. Engagement staff collected program evaluation data about partners (Veterans and researchers), projects about which the VE Panel consulted, and meeting attendance during operation of the engagement service. We created a 12-member VE Panel; all of whom had lived experience with chronic pain, prescription opioid medication use, or opioid use disorder. Engagement staff and VE Panel members implemented an engagement service operational model designed to continuously learn and adapt. The panel consulted on 48 projects spanning the research process. Seventy-eight percent of panel members, on average, attended each monthly meeting. VE Panel members and participating researchers reported high satisfaction with the quality, ease, and outcomes of their engagement service experiences. This work provides an illustrative example of how a national research consortium facilitated Veteran-engaged research and built community between Veterans and VA researchers by developing and operating an ongoing engagement consulting service, featuring a VE Panel. The service, designed as a learning community, relied on skilled engagement staff to cultivate high quality experiences and outcomes for all partners.

What Huntington's Disease Patients Say About Their Illness: An Online Direct-to-Participant Pilot Study.

Direct-to-participant online reporting facilitates the conduct of clinical research by increasing access and clinically meaningful patient engagement. We assessed feasibility of online data collection from adults with diagnosed Huntington's disease (HD) who directly reported their problems and impact in their own words. Data were collected online from consenting United States residents who self-identified as 1) having been diagnosed with Huntington's disease, 2) able to ambulate independently, and 3) self-sufficient for most daily needs. Data for this pilot study were collected using the Huntington Study Group myHDstory online research platform. The Huntington Disease Patient Report of Problems (HD-PROP), an open-ended questionnaire, was used to capture verbatim bothersome problems and functional impact. Natural language processing, human-in-the-loop curation of verbatim reports involving clinical and experience experts, and machine learning classified verbatim-reports into clinically meaningful symptoms. All 8 questionnaires in the online pilot study were completed by 345 participants who were 60.9% men, 34.5±9.9 (mean±SD) years old, and 9.5±8.4 years since HD diagnosis. Racial self-identification was 46.4% Caucasian, 28.7% African American, 15.4% American Indian/Alaska Native, and 9.5% other. Accuracy of verbatim classification was 99%. Non-motor problems were the most frequently reported symptoms; depression and cognitive impairment were the most common. Online research participation was feasible for a diverse cohort of adults who self-reported an HD diagnosis and predominantly non-motor symptoms related to mood and cognition. Online research tools can help inform what bothers HD patients, identify clinically meaningful outcomes, and facilitate participation by diverse and under-represented populations.

Paving the path for implementation of clinical genomic sequencing globally: Are we ready?

Despite the emerging evidence in recent years, successful implementation of clinical genomic sequencing (CGS) remains limited and is challenged by a range of barriers. These include a lack of standardized practices, limited economic assessments for specific indications, limited meaningful patient engagement in health policy decision-making, and the associated costs and resource demand for implementation. Although CGS is gradually becoming more available and accessible worldwide, large variations and disparities remain, and reflections on the lessons learned for successful implementation are sparse. In this commentary, members of the Global Economics and Evaluation of Clinical Genomics Sequencing Working Group (GEECS) describe the global landscape of CGS in the context of health economics and policy and propose evidence-based solutions to address existing and future barriers to CGS implementation. The topics discussed are reflected as two overarching themes: (1) system readiness for CGS and (2) evidence, assessments, and approval processes. These themes highlight the need for health economics, public health, and infrastructure and operational considerations; a robust patient- and family-centered evidence base on CGS outcomes; and a comprehensive, collaborative, interdisciplinary approach.

Patient research partner engagement in OMERACT: Enhancing engagement through the implementation of patient engagement in research tools

ObjectivesThis paper describes the evolution and impact of Patient Research Partners (PRPs) in shaping research within OMERACT and provides a framework to enhance their engagement. This session explored one component of a validated framework to evaluate meaningful patient engagement. It provides insights, identifies opportunities for improvement, and recommends using the Patient Engagement in Research (PEIR) Framework, PEIR Plan Guide (workbook), and PEIRS-22 (scale) to guide and measure PRPs' engagement. MethodsBefore the conference, the team held planning sessions and selected the Feel-Valued component of the PEIR Workbook for exploration. During OMERACT 2023, we discussed this topic using the PEIR Plan Guide in an interactive plenary session. ResultsThe plenary session produced 72 items from 14 breakout tables addressing PEIR Framework themes. ConclusionsThis paper highlights the role and evolution of PRPs in shaping research within OMERACT. It emphasizes enhancing and accurately measuring PRP engagement through the PEIR Framework, PEIR Plan Guide, and PEIRS-22. The insights and methodologies presented aim to fortify future PRP engagement, ensuring it aligns with OMERACT's principles of patient-centred research.

Growing a provincial patient and family engagement network to optimize kidney care.

Patient and family engagement is crucial for a responsive health system and improves patient outcomes. However, few practical resources for purposeful engagement are available to health leaders. Over the past fiveyears, BC Renal, the provincial kidney care network in British Columbia, developed, operationalized, and implemented a framework to enable meaningful patient and family engagement. An advisory committee, comprising patient partners and representatives from health authorities and the community, directs the outreach, resource development, and evaluation of patient and family engagement at BC Renal. Here, we describe how our network-wide patient engagement strategy was developed and expanded upon, and the progress so far. A 2022 survey reports that 95% were satisfied with the engagement opportunities, and narrative feedback suggests network members continue to adopt practical ways to collaborate more effectively. Health leaders, patient partners, and others continue to align operational and strategic activities to advance culture change in kidney care provincially.

Navigating the Landscape of Medical Device Advisories: A Special Report From the Canadian Heart Rhythm Society Device Advisory Committee

Cardiac implantable electronic devices (CIEDs) are often important for regulating cardiac rate and rhythm. Pacemakers and defibrillators are among the top 10 most implanted medical devices, with > 1.5 million devices implanted annually. Although millions of patients have benefited with improved quality of life and survival, CIED systems are becoming increasingly complex and do not always perform according to expectations. Advisory notices communicate important information about the safety and performance of a medical device to health care providers and patients. Medical device recalls are common, with > 35 unique device recalls in the past 5 years. From an ethical standpoint, CIED recalls highlight a range of considerations including the consent process, duty to report, how best to promote autonomous decision-making, trust in the health care system, as well as disproportionate effects of these considerations on equity-deserving groups. The purpose of the current article is to review and advise regarding the process around medical device advisory and recall, with a specific focus on clinicians caring for patients affected by these devices. We have sought the input of a lawyer, a patient advocacy group, and an ethicist to guide the clinical management of, and communications regarding, device recalls and advisories. Diligent surveillance and a clear, transparent patient consent process regarding these small but potentially serious device anomalies is paramount in ensuring patients believe they are safe and informed. Meaningful patient engagement helps to ensure optimal communication and disclosure mechanisms before implantation and throughout follow-up, accessibility of information in the initial implant and recall action process, and trust in health care systems and providers.

Meaningful Patient Engagement in Adolescent and Young Adult (AYA) Cancer Research: A Framework for Qualitative Studies.

Over the last two decades, patient engagement in cancer research has evolved significantly, especially in addressing the unique challenges faced by adolescent and young adult (AYA) cancer populations. This paper introduces a framework for meaningful engagement with AYA cancer patient research partners, drawing insights from the "FUTURE" Study, a qualitative study that utilizes focus groups to explore the impact of cancer diagnosis and treatment on the sexual and reproductive health of AYA cancer patients in Canada. The framework's development integrates insights from prior works and addresses challenges with patient engagement in research specific to AYA cancer populations. The framework is guided by overarching principles (safety, flexibility, and sensitivity) and includes considerations that apply across all phases of a research study (collaboration; iteration; communication; and equity, diversity, and inclusion) and tasks that apply to specific phases of a research study (developing, conducting, and translating the study). The proposed framework seeks to increase patient engagement in AYA cancer research beyond a supplementary aspect to an integral component for conducting research with impact on patients.

Studying How Patient Engagement Influences Research: A Mixed Methods Study.

There is evidence supporting the value of patient engagement (PE) in research to patients and researchers. However, there is little research evidence on the influence of PE throughout the entire research process as well as the outcomes of research engagement. The purpose of our study is to add to this evidence. We used a convergent mixed method design to guide the integration of our survey data and observation data to assess the influence of PE in two groups, comprising patient research partners (PRPs), clinicians, and researchers. A PRP led one group (PLG) and an academic researcher led the other (RLG). Both groups were given the same research question and tasked to design and conduct an inflammatory bowel disease (IBD)-related patient preference study. We administered validated evaluation tools at three points and observed PE in the two groups conducting the IBD study. PRPs in both groups took on many operational roles and influenced all stages of the IBD-related qualitative study: launch, design, implementation, and knowledge translation. PRPs provided more clarity on the study design, target population, inclusion-exclusion criteria, data collection approach, and the results. PRPs helped operationalize the project question, develop study material and data collection instruments, collect data, and present the data in a relevant and understandable manner to the patient community. The synergy of collaborative partnership resulted in two projects that were patient-centered, meaningful, understandable, legitimate, rigorous, adaptable, feasible, ethical and transparent, timely, and sustainable. Collaborative and meaningful engagement of patients and researchers can influence all stages of qualitative research including design and approach, and outputs.

Assessing clinical benefit in the Medicare Drug Price Negotiation Program: A 2-step approach for improving transparency, consistency, and meaningful patient engagement.

In early 2024, the Centers for Medicare & Medicaid Services (CMS) will send initial price offers to the manufacturers of the first 10 drugs selected for the Medicare Drug Price Negotiation Program, established under the Inflation Reduction Act. However, CMS has not specified exactly how it will adjust the starting point for an initial price offer based on assessment of a drug's clinical benefit. This article addresses unanswered questions relating to CMS' methods for assessing clinical benefit. Specifically, we address how CMS can weigh various measures of evidence, ensure transparency and consistency, meaningfully incorporate patient and other stakeholder perspectives, and support addressing evidence gaps. We propose a 2-step approach for assessing the overall clinical benefit of a selected drug compared with its therapeutic alternatives that builds on the framework outlined by CMS. In step 1, CMS would evaluate conventional clinical benefit, defined in terms of outcomes commonly used in clinical studies for the selected drug and indications. In step 2, CMS would evaluate other outcomes broadly related to patient experience that are not adequately represented in the clinical literature. Overall, our approach incorporates the advantages of both qualitative and quantitative approaches to value assessment and decision-making. We describe a set of loose decision rules to improve transparency and consistency, recommend incorporating ranks and weights to signal to researchers and manufacturers which elements of clinical benefit and sources of data are the most important, and center meaningful deliberation with clinical experts, patients, and caregivers.

Concept mapping brainstorming results for improving care transitions for adults with hip fracture in Ontario, Canada

Introduction: Individuals who have experienced a hip fracture often undergo numerous transitions in care between providers and sectors. These transitions are a time of vulnerability with the potential for poor health outcomes and experiences, yet there are limited recommendations on how to improve this care journey for adults with hip fracture.
 Target Audience: The target audience for our study include decision-makers and providers with a hip fracture portfolio, as well as patients who have experienced a hip fracture and their unpaid caregivers. 
 Who was involved: This study included patient and caregiver partners. They were involved in the grant application, study participant recruitment, data collection, and final data analysis. This study also included healthcare provider and decision-maker partners who supported participant recruitment and will be knowledge users. 
 Aims and Methods: The aim of this study was to create a list of actionable recommendations to improve care transitions for individuals with hip fracture from the perspectives of patients, caregivers, providers, and decision-makers. We used a mixed methods concept mapping approach, to gather perspectives from these key stakeholders in Ontario, Canada. Here, we report on the results of the first phase of the concept mapping study. Participants created a list of statements that they felt would improve care transitions for individuals who had experienced a hip fracture. The statements were analyzed inductively and grouped thematically. 
 Results: Thirty-two individuals participated in the brainstorming phase of this study (2 patients, 5 caregivers, 21 providers, 4 decision-makers). They created 887 statements that were condensed by the research team into 72 final statements. The final statements were grouped into seven main themes and were divided into four domains for care transition improvement. The first is the patient-related domain, which encompassed two themes: self-management and self-management-support, and rehabilitation therapy and activities. The second domain is provider-related and includes: healthcare provider skills and communication and trust. The third domain includes two system-related themes: continuity of care and health system efficiencies. The last domain relates to care processes with one theme: transition planning and follow up care. 
 Learnings for the international audience: Previous literature on improving care transitions has had focused primarily on the transfer of information between care providers with little emphasis on the caregiver/patient role. Our results, however, highlight the importance of meaningful patient and caregiver engagement, with active involvement in all aspects of care including the transition process. Further, many statements created by our participants included policies, assessments, and care specific to individuals with hip fracture and cognitive impairment/delirium, emphasizing this as an important area for consideration when aiming to improve care transitions. 
 Next Steps: The next phases of concept mapping will be conducted, which will include statement sorting and rating (importance and priority). A final concept mapping session will be held integrating the qualitative and quantitative data and an opportunity to reflect on the findings with key stakeholders. Statements that are rated highly importance and priority will inform actionable recommendations to improve care transitions for hip fracture.

#HowNotToDoPatientEngagement: the engaging with purpose patient engagement framework based on a twitter analysis of community perspectives on patient engagement

BackgroundEvaluation of patient engagement practices are frequently researcher-driven, researcher-funded, and asymmetric in power dynamics. Little to no literature on patient experiences in patient engagement exist that is are not framed by institutionally-driven research inquiries (i.e., from the lens of a research team lead, or healthcare administrative setting). Understanding these perspectives can help us understand: (i)what matters to patients when they are engaged in research; (ii)why it matters to them, and(iii) how to improve patient engagement practices, so that the needs and priorities of patients are consistently met.MethodsThis is a patient partner-initiated study. Study authors (including patient partners) conducted a conventional and summative content analysis of textual data retrieved from a highly engaged conversation on Twitter regarding the hashtags #HowNotToDoPatientEngagement and #HowToDoPatientEngagement posted between February 2018 to June 2021. Twitter is a microblogging platform that allows for free-flowing discussions between users not pre-bound by specific community groupings (like within that of Facebook).ResultsA total of 276 tweets were retrieved from 178 separate contributors across seven geographical locations. Four stakeholder groups were identified. We generated 24 codes, nine subthemes and five overarching themes: respect, support, collaboration, inclusivity and impact. Four of these themes are closely aligned with the Strategy for Patient Oriented (SPOR) Patient Engagement framework. We identify impact as a separate and new theme.InterpretationBased on our findings we offer the Engaging with Purpose Patient Engagement Framework that defines and describes respect, support, collaboration, inclusivity and impact as five key pillars of meaningful patient engagement.

Patient Engagement in Research Scale (PEIRS-22): Danish translation, applicability, and user experiences

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).

Pragmatic design and inclusion of patient-partner representatives improves participant experience in clinical research.

Patient engagement in the design and implementation of clinical trials is necessary to ensure that the research is relevant and responsive to patients. The PREP-IT trials, which include 2 pragmatic trials that evaluate different surgical preparation solutions in orthopaedic trauma patients, followed the patient-centered outcomes research (PCOR) methodology throughout the design, implementation, and conduct. We conducted a substudy within the PREP-IT trials to explore participants' experiences with trial participation. At the final follow-up visit (12 months after their fracture), patients participating in the PREP-IT trials were invited to participate in the substudy. After providing informed consent, participants completed a questionnaire that asked about their experience and satisfaction with participating in the PREP-IT trials. Descriptive statistics are used to report the findings. Four hundred two participants participated in the substudy. Most participants (394 [98%]) reported a positive experience, and 376 (94%) participants felt their contributions were appreciated. The primary reasons for participation were helping future patients with fracture (279 [69%]) and to contribute to science (223 [56%]). Two hundred seventeen (46%) participants indicated that their decision to participate was influenced by the minimal time commitment. Most participants reported a positive experience with participating in the PREP-IT trials. Altruism was the largest motivator for participating in this research. Approximately half of the participants indicated that the pragmatic, low-participant burden design of the trial influenced their decision to participate. Meaningful patient engagement, a pragmatic, and low-burden protocol led to high levels of participant satisfaction.

Operationalizing the principles of patient engagement through a Patient Advisory Council: Lessons and recommendations.

Inclusiveness, Support, Mutual Respectand Co-Build are the four pillars of patient engagement according to the Strategy for Patient-Oriented Research (SPOR). The aim of this manuscript is to describe the operationalization of these principles through the creation of a Patient Advisory Council (PAC) for the research study titled 'Re-Purposing the Ordering of Routine laboratory Tests (RePORT)'. Researchers collaborated with the Alberta SPOR SUPPORT Unit (AbSPORU) Patient Engagement Team to create a diverse PAC. Recruitment was intentional and included multiple perspectives and experiences. PAC meetings were held monthly, and patient research partners received support to function as co-chairs of the PAC. Patient research partners were offered training, supportand tailored modalities of compensation to actively engage with the PAC. Regular member check-ins occurred through reflexivity and a formal evaluation of PAC member engagement. The PAC included between 9 and 11 patient research partners, principal investigator, research study coordinator, improvement scientist, resident physician and support members from the AbSPORU team. Twelve monthly PAC meetings were held during the first phase of the project. The PAC made course-changing contributions to study design including study objectives, recruitment poster, interview guide and development of codes for thematic analysis. Patient research partners largely felt that their opinions were valued. Diversity in the PAC membership enhanced access to diverse patient participants. Furthermore, support for co-chairs and patient research partner members enabled active engagement in research. In addition, a culture of mutual respect facilitated patient partner engagement, and co-design approaches yielded rich research outputs. Collaboration between research teams and Patient Engagement Teams can promote effective patient engagement through a PAC. Deliberate and flexible strategies are needed to manage the PAC to create an ecology of Inclusiveness, Support, Mutual Respect, and Co-Build for meaningful patient engagement. Patient research partners were involved in the decision to write this manuscript and collaborated equitably in the conception and development of this manuscript, including providing critical feedback. Patient research partners were active members of the PAC and informed the research project design, participant recruitment strategies, data collection and analysis, and will be involved in the implementation and dissemination of results. They are currently involved in the co-development of a patient engagement strategy using a Human-Centered Design process.