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Introduction – Get the Facts

Canada’s Strategy for Patient-Oriented Research (SPOR) aspires for patients, researchers, health care providers and decision-makers to collaborate to build a sustainable, accessible, and equitable 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.

Although this decision tool has been designed to assist investigators in engaging patients as partners in clinical trials, investigators conducting other types of research (e.g., cohort, cross-sectional, etc.) may find this tool helpful. This decision tool is for you if:

  • You are a Principal Investigator or Co-Principal Investigator of a clinical/research team
  • You are considering engaging a patient partner on your research team
  • You have engaged a patient partner and want to access resources to submit a grant application, evaluate the patient partnership, or write a lay summary

This decision tool will provide you with enough information to decide whether you are ready to engage a patient as a partner on your research team. It will take approximately 20 to 30 minutes to review the information in this decision tool and make a decision about whether you are ready to engage a patient as a partner on your research team. If you have engaged a patient partner on your research team the information in the Learn More section of this decision tool will be valuable when planning/implementing a project, submitting a grant application, or writing a lay summary.

The decision tool is divided into five sections:

  • Introduction (Get the Facts) – An introduction to patient engagement in clinical trials/research, including patient and investigator testimonials.
  • My Priorities (What are My Priorities)? – Tools to assist investigators in determining priorities and engaging patient partners on clinical trial/study teams
  • Learn More (Resources for Engaging Patients as Partners) – Use the Research Process/Lifecycle to access resources for engaging patients as partners in designing a clinical trial, developing the grant proposal, etc.
  • My Readiness (Comparing My Priorities with perceived Benefits/Risks) – Aligning investigator priorities with the perceived benefits and risks of engaging patients as partners.
  • My Decision – My decision and next steps, including how to find a patient partner.

Frequently Asked Questions

  • The Canadian Institutes of Health Research (CIHR) 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 occurs 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.
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  • Paradigm shift in the research process to include patients on research teams.
  • Patients have an equal role in determining research priorities, developing research questions, deciding on methodology and participating in data collection, analysis, and dissemination of findings.
  • Research is done ‘with’ or by the patient/public rather than ‘to’ or for the patient/public.
  • Patients’ work with researchers, health care providers and decision-makers as partners rather than as participants.
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  • Patients should be engaged early, although they can be accessed and engaged at different points in the research process.
  • It may be appropriate to use different approaches and involve different patients in different ways at various stages.
  • Involving patients as partners in a research advisory, consultative or collaborative capacity does not require ethics approval.
  • It is within the purview of the research ethics board to consider how patient engagement has or will contribute to the clinical trial/study, and that patient partners have received sufficient training and support for their roles on the research team.
  • The Patient Engagement Quality Guidance Tool can be used to help you to plan, develop, and assess the quality of your patient engagement activities.
  • In the planning phases of your project the tool can be used to inspire and guide your patient engagement activities
  • You can use the tool to communicate the benefits of engaging patients in your clinical trial/research project (as in a grant proposal).
  • Investigators focus on different types of research (e.g., biomedical, clinical, etc.) will find the quality criteria helpful in planning patient engagement activities (e.g., biomedical researchers can engage a representative number of patient partners [men, women] who have a shared purpose, responsibilities on advisory or governance committees, and who communicate and collaborate respectfully and with transparency).
  • 7 quality criteria describe the core values of good patient engagement practice and should be considered (in this order) as you plan your clinical trial/research project:
    • Shared purpose
    • Respect and accessibility
    • Representativeness of stakeholders
    • Roles and responsibilities
    • Capacity and capability for engagement
    • Transparency in communication and documentation, and
    • Continuity and sustainability.
  • The Patient Engagement Quality Guidance Tool can also be used as an assessment tool when you have finished your clinical trial/study.
  • It can also be used for a gap analysis to identify what worked well and what could be improved as you plan your next clinical trial/study
  • Two templates are provided within the Patient Engagement Quality Guidance Tool document:
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Here are testimonials from patients who have engaged as partners on research teams.

Here are video testimonials from Investigators who have engaged patients as partners on research teams.

Some perceived benefits/advantages to including patients as partners on clinical trial/research teams include:

  • Provide valuable insights into what matters most to patients.
  • Inform trial/research design (e.g., bio-ethical issues, informed consent processes and materials).
  • Enhance recruitment and retention.
  • Conduct field work, including data collection.
  • Add insight from the patient perspective into data analysis and interpretation.
  • Assist with lay summaries and end-of-grant knowledge translation and exchange.
  • Minimize unintended consequences (e.g., trial fidelity, attrition).
  • Promote credibility and legitimacy.
  • Reduce costs and minimizes implementation issues.

Some perceived risks/disadvantages to including patient partners on clinical trial/research teams are:

  • Patient partners and researchers require training at the outset.
  • The risk of tokenism if patient partners are not engaged meaningfully.
  • Insufficient opportunities for patients to consult with others on the team.
  • Conflict of interest in duties, responsibilities, or interests (e.g., health care provider to patient partner).
  • Power dynamics and imbalances between researchers, health care providers, and patient partners.
  • Patients are not able to identify their own health needs or if their health changes during the partnership (e.g., time commitment given their current health status, blood sugar management during times of travel).
  • Failing to celebrate patient partner contribution at end of clinical trial/research project.
  • Breach of confidentiality.
  • Long-term commitment throughout the trial/research project may be difficult for patient partners.
  • Maintaining engagement during times when there appears to be little happening with the trial/research project (e.g., waiting for funding, Research Ethics Board approval[s]).
  • Co-authorship requires explicit role definitions and contributions.

There may be other risks that are not explicitly identified in this list. The Patient Partners at Diabetes Action Canada prepared a list of Do’s and Don’ts as guidelines for investigators and patient partners.

The International Association for Public Participation (IAP2) defines various levels of public/patient participation/engagement depending on goals, timelines, and available resources (IAP2 Federation). Patients can engage as partners in five various capacities, from the lowest level of inform (i.e., investigator/researcher makes decisions and informs the patient of trial/research progress) to the highest level of empower (e.g., patients make the final decision in trial/research progress and the investigator/researcher implement what the patient decides). It is likely that most patient engagement on research teams will not involve these extremes but will include consultation, involvement, and collaboration with patient partners. However, the farther right they are on the IAP2 spectrum, the more empowered patient partners will be to influence decisions regarding the clinical trial/research project. Note: SPOR is seeking to move the level of engagement to collaborate.

Patient partners can engage in each and every step of the research process/lifecycle associated with each clinical trial/research project. 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 trial research team.

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.
Introduction

These tips are provided for investigators, clinicians, and study personal to have conversations with patient partners. The goals of most conversations will include providing clinical trial/research project information to patient partners, gaining insights/perspectives from patient partners on their lived experiences, and obtaining feedback and direction from patient partners on research priorities, research project designs, outcome measures, etc.

Tips for Effective Conversations
  • Use lay language, avoid acronyms  (for more information, see CIHR’s Jargon Buster)
  • Ensure adequate introductions (of research, investigators, patient partners, etc.).
  • Listen and take questions/comments, give each patient partner ample opportunity to share their experiences, thoughts, and provide feedback.
  • Avoid medical and research jargon.
  • Be prepared with questions to ask patient partners (e.g., recruitment strategies, research methods, outcomes important for patients, etc.).

Adapted from the Tips for Research Conversations with Patient Partners, Chronic Pain Network

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).