Patient Engagement

Competency Framework

Patients and Patient Experience

• Explain the concepts of the patient, who is the patient, patient • Describe the patient experience in the health care ecosystem:
partners, caregivers, patient populations, and patient communities diagnosis, access to care and treatment, disease management,
outcomes, challenges, transitions of care, resources, and support
• Discuss the concept of diversity and its impact on the patient
experience • Recognize the ever changing social, cultural, political, economic,
and environmental impacts on the lives of patients, patient
• Identify concepts of medical need and unmet medical needs for
partners, caregivers, patient populations, patient communities, and
patients and patient communities
perspectives relative to health care, treatment choices, and access
• Describe the concepts of natural history of disease and how natural
• Explain the concepts of patient groups, patient organizations,
history is captured and documented
patient advocacy groups, including definitions/terms in use,
• Discuss the meaning of disease burden in the context of patients’, historical evolution, roles, capabilities and functions in the healthcare
caregivers’ and family members’ lives ecosystem and patient experience

Foundational Concepts of Patient Engagement in the Medical Products Life Cycle (MPLC)

• Identify the types of common basic rights patients should have in • Recognize the inputs/benefits that patients can contribute during
their healthcare experience appropriate times in the medical product lifecycle (MPLC)
• Discuss ethical, legal, and regulatory requirements when involving • Outline the types of engagement/involvement that may be
patients in research appropriate/effective at the likely points in the medical product
lifecycle (MPLC)
• State the phases of the drug/medical product lifecycle (MPLC),
including development, approval, and post-approval • Explain the concept of representativeness and the importance of
gathering input from broadly representative patient(s)
• Describe the concepts, including the evolution, of meaningful
engagement/involvement of the patient in the medical product • Explain the science of patient input
lifecycle (MPLC)
• Summarize the current and evolving regulatory interest in and
• Explain the importance of meaningful engagement/involvement recommendations/guidelines for gathering and utilizing patient
of the patient in the medical product lifecycle (MPLC), including experience data in the medical product lifecycle (MPLC)
potential benefits for patients, sponsors, and regulators
• Describe how to use the information gathered from representative
• Identify points throughout the medical product lifecycle (MPLC) patients to evaluate and validate other findings gathered from HCPs,
where patient engagement is likely to have the most meaningful surveys, and health economics and outcomes research (HEOR) data
impact and ensure that patient needs are met

Working with Patient Organizations

• Discuss the rationale for and value of partnering with patient • Evaluate organizational partners based on what stage the medical
organizations product lifecycle (MPLC) engagement is being sought, the lifecycle
stage of the organization and the various functions of patient
• Identify existing open source resources that can be used to reduce
organizations play, as well as assessing their relevant competencies
uncertainty about terms of and conditions for partnering activities
and skill in providing input at MPLC stage of interest
with patient organizations
• List the basic elements of mutually agreed upon contracts/
• Discuss the importance of relationship building and maintenance,
agreement
and engagement around mutually beneficial activities

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Patient Engagement Frameworks, Guidelines, Guidances, Standards, Good Practices

• Summarize the ethical, legal, and regulatory requirements and • Explain the patient’s and caregiver’s rights to fair compensation
considerations for patient contact and engagement for time, effort, and knowledge sharing with a sponsor during the
medical product lifecycle process
• Recognize existing guidelines, regulations, codes, and other
resources on appropriate conduct of patient engagement and • Discuss the concept of patient/caregiver/patient group
interaction with patients, caregivers, and patient organizations independence and prevention of conflict of interest situations
• Describe the legal and compliance concerns and sensitivities around
patient engagement, patient member contact and communication,
and interactions and collaborations with patient organizations

Organizational Readiness and Preparation

• Describe how an organization’s mission, goals, objectives, policies, • Outline how to establish appropriate goals and objectives for a
guidelines and processes within the R&D and commercial enterprises comprehensive patient engagement program within an organization
relate to patient engagement goals and approaches
• Review existing polices and identify key areas that require
• Describe approaches to determine attitudes about patient focus policies and guidelines to ensure a quality comprehensive patient
from leadership and key functional areas within the organization engagement program
• Identify methods used to assess the landscape of patient focus and • Describe the impact of the collaborative process within the
patient involvement efforts within the organization organization and with external stakeholders when developing a
comprehensive patient engagement program
• Describe the knowledge, skills and resources that are typically
needed to implement a quality patient engagement program • Explain the program/project planning and development process
• Discuss approaches to influencing cultural change within the • Recognize informational and supportive resources for organizational
organization to encourage patient focused behaviors capacity building, patient engagement program development, and
patient engagement practices
• Describe the role of a centralized patient engagement function
within an organization • Discuss how to use sources of data to inform the inclusion of the
patient perspective into key strategic initiatives
• Discuss common organizational approaches to ensuring coverage
of roles and responsibilities for patient engagement across multiple
functions within the organization

Patient Engagement Evaluation, Measurement, and Metrics

• State the importance of evaluation of patient-focused/patient • Explain the methods used to develop data sources for patient
engagement efforts engagement evaluation
• Identify the key principles of evaluation • Express appropriate analysis and reporting of patient engagement
evaluation data
• Discuss the elements of patient-focused/patient engagement efforts
that can be evaluated: Process, Quality, Outcomes, Return • Describe effective dissemination and use of results of patient
engagement evaluation both with internal teams and with external
• Describe the evaluation methods often used for each element of
(patient, patient organization) participants
patient-focused/patient engagement efforts
• Discuss the process for developing patient engagement metrics,
including setting objectives, defining expected outcomes, and
identifying relevant measures

© 2021 DIA, Inc. All rights reserved.