Nothing About Us Without Us: Patient Involvement in Research
Until recently, patient participation in research was limited to their involvement as subjects enrolled in research studies, but there is a shift occurring as funding bodies increasingly look for evidence of patient and public involvement (PPI) in research proposals. The rationale for this is increasing evidence that PPI in the provision of healthcare leads to improved outcomes and better quality of care.
Assumptions are made every day about patients; assumptions which may lead to a failure to deliver optimum care. When these assumptions extend to research, quite often there is a mismatch between the questions that patients want answers to and the ones that researchers are investigating. As an example, the research priorities of patients with osteoarthritis of the knee, and the clinicians looking after them, were shown in a study to favor more rigorous evaluation of physiotherapy and surgery, and assessment of educational and coping strategies. Only 9% of patients wanted more research on drugs, yet over 80% of randomized controlled trials in patients with osteoarthritis of the knee were drug evaluations. PPI recognizes that patients bring a unique perspective and experience to the decision-making process in research. It is paternalistic and patronizing to rely on speculation about patient experience. By considering the actual experience of patients, researchers can make more informed research decisions. Involving patients is an important step in ensuring that the real life experiences of patients are considered when it comes to setting research priorities. This in turn will increase the relevance of research to patients and improve research quality and outcomes.
As an advocate you may be asked to become involved in a research project, so it is important to have a clear understanding of what PPI is – and what it isn’t. PPI is not about being recruited as a participant in a clinical trial or other research project, donating sample material for research, answering questionnaires or providing opinions. PPI describes a variety of ways that researchers engage with people for whom their research holds relevance. It spans a spectrum of involvement which may include any of the following:
- Being involved in defining the research question
- Being a co-applicant in a research proposal
- Working with funders to review patient-focused section of applications
- Being an active member of a steering group for a research study
- Providing your input into a study’s conception and design
- Contributing to/proofing of documentation
- Assisting in the implementation and dissemination of research outcomes
- Improving access to patients via peer networks and accessing difficult-to-reach patients and groups
Effective PPI transforms the traditional research hierarchy in which studies are done to, on, or for participants into a partnership model in which research is carried out with or by patients. PPI should always involve meaningful patient participation and avoid tokenism. The Canadian Institutes of Health Research Strategy for Patient-Oriented Research (SPOR) describes PPI as fostering a climate in which researchers, health care providers, decision-makers and policy-makers understand the value of patient involvement and patients see the value of these interactions. Underpinning this framework are the following guiding principles for integrating patient engagement into research:
- Inclusiveness:Patient engagement in research integrates a diversity of patient perspectives and research is reflective of their contribution.
- Support:Adequate support and flexibility are provided to patient participants to ensure that they can contribute fully to discussions and decisions. This implies creating safe environments that promote honest interactions, cultural competence, training, and education. Support also implies financial compensation for their involvement.
- Mutual Respect:Researchers, practitioners and patients acknowledge and value each other’s expertise and experiential knowledge.
- Co-Build:Patients, researchers and practitioners work together from the beginning to identify problems and gaps, set priorities for research and work together to produce and implement solutions.
Derek Stewart, a patient advocate and Associate Director for Patient and Public Involvement at NIHR Clinical Research Network, sees a growing momentum of actively involving patients and public in research gathering pace worldwide. “It is really pleasing to hear researchers saying how valuable it has been to involve patients and the public in their work”, he says. “It has equally improved the quality of the research and enriched their own thinking and understanding.”
Earlier this year, PCORnet, the National Patient-Centered Clinical Research Network, announced its first demonstration study which reflects PCORnet’s aims of patient engagement and open science. ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) will compare the effect of two different aspirin doses given to prevent heart attacks and strokes in high-risk patients with a history of heart disease. Seeking input at every critical step, from consent design and protocol development, through dissemination of final study results, the project represents a new research paradigm. Unprecedented in the design of clinical trials, the final consent form and protocol were shaped with input from patients, local institutional review boards, physicians, and study coordinators.
Another noteworthy example of PPI can be found in the Metastatic Breast Cancer Project a direct-to-patients initiative launched at the Broad Institute of MIT and Harvard last October. Corrie Painter, an angiosarcoma patient and Associate Director of Operations and Scientific Outreach at Broad Institute, explains that “the project seeks to greatly accelerate the pace of biomedical research by empowering patients to directly contribute to research and was built in lock step from design to consent language with dozens of patients.”
To what extent you may wish to be involved in PPI will depend on several factors. Do you have professional experience (e.g. project management, clinical experience, etc.) which would be useful? Are you happy to work as part of a team? Or would you prefer to work on your own? You should also take into consideration your other work or family commitments. For instance will you need to take time off work to attend meetings? Consider also at what point you are in your own health journey. Will participation in research place an added burden on your treatment or recovery? In making the decision to become involved in research, you should always balance your own health needs with the desire to be supportive of research and the research process.
Metastatic Breast Cancer Project www.mbcproject.org
A Stanford Medicine X e-Patient scholar, Marie Ennis O’Connor is an internationally recognized keynote speaker, writer, and consultant on global trends in patient engagement, digital health and participatory medicine. Marie’s work is informed by her passion for embedding the patient voice at the heart of healthcare values. She writes about the experience of transitioning from breast cancer patient to advocate on her award-winning blog Journeying Beyond Breast Cancer.