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Introduction – Get the Facts

Canada’s Strategy for Patient-Oriented Research (SPOR) aspires for patients, investigators, health care providers and decision-makers to collaborate to build a better health care system. Patients must be meaningfully engaged as partners in health research to ensure the needs of Canadians are being addressed. This includes focusing on priorities important for patients and producing results that inform policy and are taken up to improve the health of Canadians.

This Patient-Oriented Research Collaboration Project was supported by the Canadian Institutes of Health Research (CIHR) and funding was also provided by the Ontario SPOR SUPPORT Unit, which is supported by the Canadian Institutes of Health Research and the Province of Ontario.

Decision aids are usually used by patients and healthcare providers to make treatment decisions together. These decision aids for patient engagement in research are based on healthcare decision aids and use the same type of format to help make a decision. Like healthcare decision aids, this decision tool is divided into five sections:

  1. Introduction (Get the Facts) – An introduction to patient engagement, patient-oriented research and clinical research in general, including some topics you may consider, such as the different roles a patient may take on as a partner in a research study, potential time and cost, etc.
  2. My Priorities (What are My Priorities) – Tools to help you decide the priority areas in which you could see yourself engaged as a patient partner on clinical research teams.
  3. Learn More (Resources for Engaging) – A section that shares information about the Research Process/Lifecycle to learn more about being part of the research team, including the research process, potential stages of involvement, evaluating the experience of being included as a patient partner, compensation, and other helpful information.
  4. My Readiness (Comparing My Priorities with Perceived Benefits/Risks) – Aligning your priorities with the perceived benefits and risks of engaging as a patient partner on a clinical research team.
  5. My Decision (Next Steps) – Making your final decision and potential next steps if you feel you are ready to be engaged.

Frequently Asked Questions

This decision aid is meant to help you decide if you are ready to be part of a patient-oriented research team. Reading and working through each section is meant to help you consider a number of factors related to patient-oriented research in clinical research, as well as provide you with links to other reliable resources and information. This decision aid will also be useful if you know you are ready to be on a research team, but want more information (e.g., about compensation, working in a team, etc.). This type of information is found in the Learn More section of the decision aid.

The Canadian Institutes of Health Research (also abbreviated as CIHR, the federally-funded organization that provides funding for health-related research in Canada) defines ‘patient’ as “An overarching term inclusive of individuals with personal experience of a health issue and informal caregivers, including family and friends.”

Patient engagement happens when patients meaningfully and actively collaborate in the governance, priority setting, and conduct of research, as well as in summarizing, distributing, sharing and applying its resulting knowledge (patients who are involved in any of these roles are defined as patient partners).

CIHR’s Institute of Musculoskeletal Health and Arthritis (IMHA) have developed training modules for patient partners, researchers, trainees, clinicians, and other members of research teams. See IMHA resources and training modules for Patient Engagement.  Please note that you will need to create an account to access the patient engagement training modules.

References

Patient-Oriented Research is research where:

  • The research process includes patients on research teams. This is a change in how things are usually done in research.
  • Patients have an equal role in deciding what should be studied, developing research questions, deciding on how the research will be done and participating in data collection, analysis and sharing of findings.
  • Research is done ‘with’ or by the patient/public rather than ‘to’ or for the patient/public.
  • Patients work with investigators, health care providers and decision-makers as partners rather than as participants in the research itself.
  • Patient experiences and feedback are taken into consideration when developing the research project.
References

Below is some general information about clinical trials. You may also wish to visit Learn About Clinical Trials.

Clinical trials:

  • Are a type of research that involve people and that test health-related “interventions” to see how they work
  • Often answer questions like: Is the intervention safe? Does the intervention improve or cure disease, or help people live longer with disease than other treatments? Does the intervention help people feel better?
  • Test many types of interventions. While we often think about clinical trials being done to test drugs, they also test devices, genetic therapies, natural health products, psychotherapies, lifestyle and preventive care interventions, and many other things.
  • Study interventions that may be very experimental with little to no evidence about how they might work in people (e.g., new drugs) or may be already commonly used by people but more evidence is needed about how they work.
  • Are carefully designed and planned to make sure that risks to the people participating are minimized to the extent possible, and that the questions asked about the intervention(s) can be answered when the trial is finished.

In this section there are some short videos about patient partners’ experiences on clinical trial and research teams as well as investigators’ experiences with including patient partners on their clinical research teams.

Videos from Patient Partners

Being a patient partner on a clinical research team may be based on your own motivations and personal experiences. Some reasons may include:

  • Helping others by sharing information about your disease or condition.
  • Developing relationships with investigators and/or with other patients.
  • Having influence on how research is done and on what type of research is done (including helping define the research questions based on things that are important to patients).
  • Learning more about research and how it works.
  • Having time to contribute to research and science.

You may also have other personal reasons not listed here.

References

Research is a process, and there may be a number of areas in which patient partners may contribute throughout the clinical research/study process including:

  • Identifying and Prioritizing — This refers to identifying and prioritizing objectives and outcomes of a clinical study and may include you sharing what research is important to you as a patient based on your own experiences and helping develop the research question that the team will answer.
  • Designing — This refers to providing input into the design of a study and may include giving feedback from your lived experience perspective on: the research plan, the materials that would be provided to potential participants, and the planned outcomes for the study that would be measured, etc.
  • Developing the Grant Proposal — This may include helping develop the research questions to be answered, helping define characteristics of study participants, providing input to help design a study that fits into the lives of patients.
  • Preparing to Do the Study — This might include reviewing materials such as posters and informed consent wording that will be provided to potential participants. You might also know organizations that would be willing to share information about the study with their own stakeholders or individuals who might wish to consider participating in the study.
  • Collecting Data — Depending on your involvement with the research team, you might be involved in working with participants in the study, for example, to help administer surveys or participate in interviews or focus groups.
  • Analyzing and Interpreting Data/Results — When the study’s data is analyzed, you might work with the team to understand what the results are and offer opinions based on your lived experience about the results.
  • Disseminating — This means helping share the results, which might involve working the team to develop lay summaries about the results of the study, participating in presentations about the study, and writing or reviewing manuscripts about the study. You might also share these materials and results with organizations to which you have links and that would be interested in learning about the research and its results. Sometimes you will hear these activities called Knowledge Translation and Exchange.
  • Implementing — This may include developing a plan to implement the findings of the research into everyday practice.
  • Monitoring and Evaluating — This may include regular review of the study as it is ongoing, including recruitment activities, data collection and analysis, etc. It could also include being a Patient Representative on the Data Safety Monitoring Board of a clinical trial (also called a DSMB). A DSMB is made of people who are external experts to the clinical trial They regularly review data from the clinical trial and advise about safety of the participants, validity, and scientific merit of the clinical trial.
References

These topics are discussed in much more detail in the next section, while here they are introduced to you.

It is best practice for your expenses to be paid as a patient partner on a clinical research team. It should not cost you money to be engaged as a patient partner on a clinical research team. Many organizations will book travel arrangements or make other arrangements for you so you are not out of pocket in terms of getting expenses reimbursed.

Sometimes compensation is provided to you for your time and expertise as a patient partner, and sometimes it is not. If this is important to you, this is a discussion that you can have with the main investigator on the team, and in the next section there is some guidance for you around some considerations and ways to approach this topic.

If you are considering being a patient partner on a clinical research team, it is a good idea to have a discussion with the lead investigator about expectations about time commitment and what best works for your in terms of your involvement in the project. The potential time required to be a patient partner on a clinical research team may depend on the length of the research project, how it is funded, and your role in the team. While the research team may have expectations about time commitment, these can always be discussed and negotiated.

There may be some potential benefits and risks associated with you being a patient partner on a clinical research team. These lists are not complete – you might think of other benefits and risks that are not listed here and that are important to you.

Potential benefits may include the ability to:

  • Provide insight into what matters most to people like you.
  • Inform the design of the study and materials that participants are provided (e.g., bio-ethical issues, protocol design, informed consent processes, etc.).
  • Assist with recruitment approaches for participants.
  • Do research, including data collection.
  • Provide insight from a patient perspective into data analysis and interpretation of the data.
  • Help with lay summaries of the study and “knowledge translation and exchange” [for example, helping present or presenting the work or helping write or comment on the papers (also called publications) about the work].
  • Minimize unintended consequences or potential risks to participants by providing insights through a potential participant’s perspective and via your own lived experiences.
  • Help provide credibility and legitimacy to the research through your involvement on the team.
  • Feel that you have contributed to research that may help others and move knowledge forward in the research area.
  • Meet and work with investigators, health care providers, other patient partners, and policy makers.
  • Reduce cost and help reduce potential study implementation issues.

Potential risks may include:

  • Feeling that your contributions are not being heard or valued or that your role in the team is tokenistic.
  • Feeling vulnerable by sharing very personal experiences and information about yourself.
  • Not getting along with the research team, or members of the research team.
  • Not being able to spend the time you want to as part of the team because of health or life reasons.
  • Feeling conflicted if you are working on a team that includes one of your health care providers.
  • Feeling unengaged or uninformed during times when there appears to be little happening with the study (e.g., waiting for funding, Research Ethics Board approval[s]).

The International Association for Public Participation (also called IAP2 for short) has created the table below that shows levels of participation that patient partners may have on clinical research teams.

Patient partners can engage as in five capacities, from the lowest level of inform (i.e., investigator makes decisions and informs the patient of study progress) to the highest level of empower (e.g., patients make the final decision in study progress and the investigator implements what the patients decide). It is likely that most patient engagement on a clinical research team will not involve these extremes but will include consultation, involvement and collaboration with patient partners. However, the farther right you are on the IAP2 spectrum, the more empowered patient partners will be to influence decisions regarding the study. Note: SPOR is seeking to move the level of engagement of collaborate and higher.

Depending on how and where patient partners wish to be involved in the project, involvement according to this spectrum may be ‘fluid.’ That means for different parts of the project, patient partners may be involved at a different level of the spectrum. Or perhaps as patient partners become more comfortable with the project, the team, and their role, again they may be involved at different levels of the spectrum.

Patient partners can engage in each and every step of the research process/lifecycle associated with each study. The level or spectrum of engagement, defined earlier using the IAP2 criteria, is a very useful tool for defining Patient Partner Roles and Responsibilities within a clinical research team.

IAP2 Spectrum
Public Participation GoalPromise To The Public
InformTo provide the public with balanced and objective information to assist them in understanding the problem, alternatives and/or solutions.We will keep you informed.
ConsultTo obtain public feedback on analysis, alternatives and/or decision.We will keep you informed, listen to and acknowledge concerns and aspirations, and provide feedback on how public input influenced the decision.
InvolveTo work directly with the public throughout the process to ensure that public concerns and aspirations are consistently understood and considered.We will work with you to ensure that your concerns and aspirations are directly reflected in the alternatives developed and provide feedback on how public input influenced the decision.
CollaborateTo partner with the public in each aspect of the decision including the development of alternatives and the identification of the preferred solution.We will look to you for advice and innovation in formulating solutions and incorporate your advice and recommendations into the decisions to the maximum extent possible.
EmpowerTo place final decision-making in the hands of the public.We will implement what you decide.
This table has been developed by and used with permission of the International Association for Public Participation (IAP2) International Federation.

Sometimes it’s helpful to have a glossary with research terms for you to reference. The Canadian Institutes of Health Research has created a glossary of terms that may be useful.

Contact

This decision aid is part of an ongoing research project. Project team members include:

  • Monica Parry, University of Toronto (Principal Investigator)
  • Tina Ceroni, Clinical Trials Ontario (Principal Knowledge User)
  • Marianne Park, Network of Women with Disabilities (Knowledge User)
  • Ann Kristin Bjørnnes, Oslo Metropolitan University (Co-Applicant)
  • Anne Ellis, Queen’s University (Co-Applicant)
  • Ian Gilron, Queen’s University (Co-Applicant)
  • Dawn Richards, Clinical Trials Ontario (Co-Applicant)
  • Karine Toupin-April, University of Ottawa (Co-Applicant)
  • Adhiyat Najam, Diabetes Action Canada (Knowledge User)
  • David Wells, Diabetes Action Canada (Knowledge User)
  • SalimaHemani, University of Toronto (Trainee)
  • Clinical Trials Ontario (Collaborating Partner)

If you have any questions or comments about the decision aid, please send them to spor.decisiontool@utoronto.ca or call 1-833-543-4916.

Funding for the development and dissemination of the Investigator Decision Aid has been provided by the Canadian Institutes of Health Research (CIHR) (Application #397455) and the Ontario SPOR Support Unit (OSSU).