New resources to improve patient and public involvement in health research
Long COVID-based research used to form new tools for maximising involvement from patients and public groups
Peer-Reviewed PublicationPatients and members of the public will be able to more easily take part in impactful research thanks to a new tool developed by the University of Birmingham’s work on Long COVID.
These resources are detailed in a paper published today in Nature Medicine from researchers working within the University of Birmingham’s Institute of Applied Health Research, the NIHR Birmingham Biomedical Research Centre (BRC) and NIHR Applied Research Collaboration West Midlands, reporting the evaluation of patient and public involvement and engagement (PPIE) for the Therapies for Long COVID in non-hospitalised individuals (TLC) Study.
Researchers can use the new tool to guide in the planning, implementation and evaluation of projects that work with patient and public groups. The tool draws on best practice and enables researchers to follow checklists to ensure that all aspects of PPIE work are incorporated into research design.
The TLC Study was funded by the UK’s National Institute for Health and Care Research (NIHR) and UK Research and Innovation to investigate the burden of Long COVID on patients, provide a better understanding of the condition, and explore potential interventions. As the long-term effects of Long COVID are yet to be fully understood, involving individuals with lived experiences of the condition was key to the success of the study.
The paper covers the impacts and outcomes of PPIE throughout all stages of research, reflecting on areas of success and improvement – from the development of the grant application and study set up, to study design, the co-creation of data gathering tools and interventions, and the dissemination of the findings.
Researchers faced especially tight time and resource constraints, as the TLC study was conducted in the context of urgent population-level medical need and its outcomes would inform national policy. However, by adopting a flexible approach with public contributors and providing different opportunities and modalities to get involved, the group succeeded in maximising patient involvement within the constraints of the study timeline.
As a legacy of this work, the TLC Study Group created two checklists with key and desirable considerations for PPI to be used in all studies. These are based on items that were deemed the most important by patient partners and researchers involved in the project, and cover all stages and aspects of research.
The full list of domains on the checklists comprises: development of grant proposal, project set-up, study design, undertaking research, dissemination of study findings and engagement, practical considerations, membership of PPIE group, and evaluation of PPIE. By using this tool, other medical researchers will now be able to better plan, implement, and evaluate PPIE for future studies.
Professor Melanie Calvert, Director of the University of Birmingham’s Centre for Patient-Reported Outcomes Research (CPROR), co-lead of the BRC Patient Reported Outcomes research theme and co-PI for the TLC study, said: “Patient partners play a central role in our research team, helping us understand what matters to them and ways to make our research more inclusive and accessible. Building relationships is key, but it takes time and there is a lot to consider to ensure meaningful engagement. Together with our patient partners, we have summarised key considerations for patient and public involvement in health research. Although we provide checklists, this should not be a tick box exercise – our work aims to support a considered approach to working in partnership with patients and the public to influence and shape research, that can in turn inform care and improve health outcomes.”
Dr Lee Aiyegbusi, Associate Professor at the University of Birmingham’s CPROR, co-lead of the BRC Patient Reported Outcomes research theme, and PPI lead of the TLC study, commented: “The active involvement and engagement of patient partners has had tangible and substantial impacts on the TLC study. We hope that other researchers can draw on our experience and use the checklists which we have developed and reported in this article to facilitate patient and public involvement and engagement in future health research.”
Patient partner Flic Jeyes said: “Research is fantastic in moving the world forward and providing us with evidence to prepare us all for tomorrow. Including PPI in research ensures that studies focus on real life needs, as lived and breathed by real people, and have a tangible impact for the communities we live in.
“Working with the University of Birmingham as a PPI partner to the TLC study I have felt empowered to contribute, while being encouraged to respect my own needs and limitations as someone living with Long COVID. I have been able to grow in confidence, offer suggestions that influenced the direction of the study, and learnt to balance that with a long-term health condition.”
JOURNAL
Nature Medicine
ARTICLE TITLE
Considerations for patient and public involvement and engagement in health research
ARTICLE PUBLICATION DATE
20-Jul-2023
PCORI makes first funding awards to advance the science on engaging patients, caregivers and other partners in health research
Seven projects to focus on bolstering approaches and measures for effective engagement in research
IMAGE: THE PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE (PCORI) IS AN INDEPENDENT NONPROFIT ORGANIZATION AUTHORIZED BY CONGRESS IN 2010. ITS MISSION IS TO FUND RESEARCH THAT WILL PROVIDE PATIENTS, THEIR CAREGIVERS AND CLINICIANS WITH THE EVIDENCE-BASED INFORMATION NEEDED TO MAKE BETTER-INFORMED HEALTH CARE DECISIONS. PCORI IS COMMITTED TO CONTINUOUSLY SEEKING INPUT FROM A BROAD RANGE OF STAKEHOLDERS TO GUIDE ITS WORK. view more
CREDIT: HTTPS://WWW.PCORI.ORG/ABOUT/GOVERNANCE/TRADEMARK-USAGE-GUIDELINES
WASHINGTON, DC – The Patient-Centered Outcomes Research Institute (PCORI) today announced the approval of $9 million for the first seven studies through its groundbreaking Science of Engagement initiative. An unprecedented research program dedicated to funding studies to demonstrate how best to engage patients, caregivers and other health care community members in comparative clinical effectiveness research (CER) and other health research, the initiative aims to grow a more robust evidence base to advance patient-centered, community-driven approaches to conducting research.
Since its establishment in 2010, PCORI has accelerated the movement toward transforming health research into a community-driven, participatory enterprise that involves those who ultimately use and rely on study results as partners throughout the research life cycle. PCORI’s efforts have produced a growing number of resources for building multistakeholder research teams and collaboration in CER studies.
Although these and others’ efforts over many years have shown that partner engagement enhances studies in meaningful ways, little systematic evidence exists about why engagement activities achieve the observed effects and which methods are most successful so that those approaches can be employed by others. Additionally, there are critical evidence gaps about how to facilitate and promote inclusion of historically underrepresented populations as partners in patient-centered CER as well as how to measure the impact of including a diverse array of patients and other research partners on study outcomes.
“The time is right to catalyze this nascent field of study called the science of engagement in order to transform our nation’s health research enterprise into a truly patient-centered, community-driven endeavor. Such an enterprise engages those who for far too long have been largely left out of health research,” said PCORI Executive Director Nakela L. Cook, M.D., MPH. “As more and more research teams seek to conduct research in a patient-centered way, PCORI’s Science of Engagement initiative addresses the surging demand for data on how to do it robustly, inclusively and genuinely, and for validated and rigorous ways to measure its effects.”
The first seven studies funded through this initiative focus on the foundational areas of developing or validating measures of engagement and developing and testing engagement techniques. One project, for example, will develop a survey of co-creation in the design and conduct of studies and another will develop a survey of adolescent engagement in research. Another study will compare methods for engaging children, adolescents and their parents with low health literacy.
Several of the projects will consider strategies to improve outreach to and involvement of populations that have been underrepresented in research, including people with limited health literacy skills, people from underserved communities, and children and adolescents.
Research teams for all funded studies will participate in a PCORI Science of Engagement Learning Network that will provide opportunities to engage in peer learning and sharing as well as offer lessons learned to the field.
PCORI launched the Science of Engagement initiative in 2022 with an initial investment of up to $36 million over three years to bolster development of a toolbox of validated measures of engagement. Future Science of Engagement funding awards will advance evidence on the mechanisms by which engagement techniques contribute to research studies’ processes and outcomes and test which approaches are most effective.
“The comprehensive approach and scale with which PCORI has implemented engagement—requiring engagement in all the comparative clinical effectiveness research studies it funds—has served and continues to serve as a laboratory for innovation,” said Harv Feldman, M.D., MSCE, PCORI’s deputy executive director for patient-centered research programs. “PCORI is building on its important work in this area to date to advance a systematic understanding of how to most effectively conduct engagement in research with different individuals and communities. This will strengthen patient-centered, community-driven CER as well as benefit the entire health research enterprise.”
The Science of Engagement funding awards were approved pending a business and programmatic review by PCORI staff and the issuance of formal award contracts. With these latest awards, PCORI has invested more than $4 billion to fund patient-centered CER and support other projects designed to enhance CER methods, engagement, dissemination and implementation, and the infrastructure necessary to conduct CER efficiently. Details of all studies and projects approved for PCORI funding to date are available on PCORI’s website.
About PCORI
The Patient-Centered Outcomes Research Institute (PCORI) is an independent nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health care decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work.
Wake Forest University School of Medicine approved for $4.4 million PCORI funding award to study telehealth
WINSTON-SALEM, N.C. – July 20, 2023 – A team of researchers at Wake Forest University School of Medicine has been approved for a $4.4 million funding award from the Patient-Centered Outcomes Research Institute (PCORI) to assess the benefits of expanding telehealth by primary care physicians to children with complex chronic conditions and their caregivers. The project is a collaboration with Atrium Health Wake Forest Baptist Brenner Children's in Winston-Salem and Atrium Health Levine Children’s in Charlotte.
The award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
Telehealth experienced a rapid expansion with the COVID-19 pandemic, but questions remain about the most effective, evidence-based ways to incorporate telehealth as part of routine care, especially in chronic disease management, and how best to mitigate health disparities.
“In-person appointments can be incredibly challenging for families with medically fragile children,” said Savithri Nageswaran, MBBS, professor of pediatrics at Wake Forest University School of Medicine and co-principal investigator of the study. “Caregivers often must miss work to attend the many in-person appointments these children need, which can cause a financial strain. There’s also an enormous amount of planning ahead of time, given the medical complexity of the child, with feeding and medicines.”
Researchers will conduct a multicenter randomized control trial to test the benefits of a telehealth intervention called enhanced primary care (E-PRIME) at 36 primary care pediatric offices across North Carolina.
The research team plans to enroll 400 children who will be randomized to either the early (first six months of the study) or delayed implementation (later six months of the study) of E-PRIME.
“Our primary objective is to improve the delivery of care to these children,” said Sabina Gesell, Ph.D., professor of social sciences at Wake Forest University School of Medicine and co-principal investigator of the study. “We would really like to understand health disparities in this population, and we expect to recruit at least 180 children from minority groups.”
The research team will evaluate the effectiveness of E-PRIME by measuring hospitalizations, emergency room visit rates and caregiver stress. All participants will be followed for one year.
“This study was selected for PCORI funding for its potential to answer the need for real-world evidence about how best to incorporate telehealth into the primary care of people with multiple chronic conditions and how this may differ among populations at risk for health disparities,” said Nakela L. Cook, M.D., the executive director of PCORI. “We look forward to following the study’s progress and working with Wake Forest University School of Medicine to share the results.”
PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health-care decisions.
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