Patient Engagement
Patient engagement is essential for clinical trials to produce relevant and actionable results. People With Lived Experience (PWLE) frequently encounter barriers in engaging meaningfully in clinical trials. PCORI’s guidance offers solutions to many of these challenges and provides examples that could serve as a foundation for national guidelines on patient engagement. Below, we correlate common PWLE challenges with PCORI’s resources and discuss their potential to inform national standards.
1. Lack of Clarity on Roles and Expectations
PWLE Problem: Patients often do not understand their roles or how their contributions influence the study.
PCORI Guidance:
- PCORI’s Engagement Plan Template requires researchers to define stakeholder roles and expectations clearly, ensuring transparency and shared understanding.
PCORI Engagement Plan Template - The Patient-Centered Outcomes Research Training Manual provides actionable steps to educate and integrate patient partners effectively into research teams.
Patient-Centered Outcomes Research Training Manual
National Guideline Potential: A standardized engagement plan template could ensure all clinical trials articulate clear, accessible roles for PWLE.
2. Inadequate Compensation
PWLE Problem: Many PWLE feel their time and contributions are undervalued due to insufficient compensation.
PCORI Guidance:
- The Compensation Framework offers detailed guidance on fair remuneration based on the scope and intensity of engagement activities.
PCORI Compensation Framework
National Guideline Potential: Adopting PCORI’s Compensation Framework as a baseline could standardize fair compensation practices across trials.
3. Tokenism
PWLE Problem: Some patients feel their involvement is superficial and meant to meet requirements rather than shape research.
PCORI Guidance:
- PCORI evaluates Engagement Plans during its merit review process to ensure meaningful integration of stakeholder feedback.
PCORI Merit Review Process
National Guideline Potential: Requiring merit reviews of engagement plans could reduce tokenism and hold researchers accountable.
4. Poor Communication
PWLE Problem: Inconsistent updates and unclear communication create frustration for participants.
PCORI Guidance:
- PCORI’s engagement resources stress the importance of transparent and regular communication, including best practices from its Engagement Tool Repository.
PCORI Engagement Tool Repository
National Guideline Potential: Establishing mandatory communication protocols could improve trust and participation.
5. Limited Accessibility
PWLE Problem: Accessibility issues like lack of transportation or accommodations deter engagement.
PCORI Guidance:
- PCORI’s Budgeting for Engagement Activities guide encourages researchers to allocate funds for removing barriers, such as transportation or digital access tools.
PCORI Budgeting for Engagement
National Guideline Potential: Federal mandates for accessible engagement budgets could make participation equitable.
6. Exclusion of Diverse Perspectives
PWLE Problem: Marginalized groups are often underrepresented in clinical trials.
PCORI Guidance:
- Programs like the PCORI Ambassador Program and Capacity Building Awards focus on outreach to underrepresented communities.
PCORI Ambassador Program
PCORI Capacity Building Awards
National Guideline Potential: Standardizing diversity benchmarks for participant recruitment could improve inclusivity.
7. Lack of Transparency in Study Outcomes
PWLE Problem: Participants often feel disconnected from results or their impact.
PCORI Guidance:
- PCORI’s Guidance for Dissemination and Implementation encourages researchers to share outcomes and the role of patient contributions.
PCORI Dissemination Guidance
National Guideline Potential: Requiring post-study communication with participants could enhance transparency.
8. Overburdening of Participants
PWLE Problem: Patient partners may be overwhelmed by the time commitment or the complexity of tasks.
PCORI Guidance:
- The Compensation Framework accounts for time-intensive tasks, while engagement tools help researchers create balanced roles.
PCORI Engagement Tools
National Guideline Potential: Mandating regular feedback from participants could help tailor engagement activities to capacity.
9. Lack of Training for Researchers
PWLE Problem: Researchers often lack skills or experience in effective patient engagement.
PCORI Guidance:
- PCORI’s Training Manual and webinars offer practical training for researchers on integrating patient partners.
PCORI Webinars and Training
National Guideline Potential: Requiring engagement training for all research teams could improve researcher-patient collaboration.
10. Failure to Adapt Engagement Strategies
PWLE Problem: Static strategies fail to meet evolving patient needs during long-term studies.
PCORI Guidance:
- PCORI emphasizes iterative engagement planning, revising strategies based on ongoing feedback and evaluation.
PCORI Engagement Plan Template
National Guideline Potential: Embedding flexibility into national engagement standards could improve long-term collaboration.
Why PCORI’s Guidance Should Inform National Guidelines
PCORI’s frameworks are not just theoretical but proven practices from real-world implementation. By adopting PCORI’s:
- Engagement Plan Requirements: National guidelines could ensure clarity, equity, and accountability.
- Compensation Framework: Standardized compensation could make patient engagement sustainable.
- Training and Toolkits: Mandatory researcher training could improve the quality of engagement.
- Inclusivity Standards: National recruitment benchmarks could promote diversity and accessibility.
- Transparency Protocols: Sharing study results and participant impact could build trust and increase engagement.
Incorporating PCORI’s comprehensive, patient-centered approach into national guidelines could transform patient engagement across all clinical trials.
Acknowledgment
This article was developed with assistance from ChatGPT, an AI language model by OpenAI, providing research and drafting support.