“Who is the Patient?” Tool

Defining the Terms

At the National Health Council, we often use the word “patient” in a very broad sense to capture all types of representatives from a specific community of interest, which includes patients, carers/caregivers, family members, and other types of patient representatives.ⁱ All have the ability to provide valuable information for PC-CIS development. In this document we have clarified whose views each person represents. In this context, we propose to distinguish the role of the patient and patient representative to avoid confusion about and/or variability in who the patient is and who acceptable patient representatives are.

Who is a patient?

Patients are individuals with lived experience with disease and can include those with current, active disease symptomology or disability, those with episodic or remitting/relapsing illness, those without current, active disease symptomology or disability but at risk of onset, and those who have survived a potentially fatal disease but are at risk of recurrence.

Who can be a patient representative?

A patient representative is a person who can speak on behalf of a community of patients with a condition or disease and can include patients, carers, family members and patient-group staff members. The question is how can we be sure this person is able to speak for that community?

How to identify the right patient or patient representatives to partner on the development of a PC-CIS

Determining which patient or type(s) of patient representative(s) are best to include as patient partners in an activity like PC-CIS development will depend on the type of patient input you need for the activity being undertaken. Even when the PC-CIS creation is being led or co-led by patients (as is the expectation), there is not always one clear, straightforward answer for this. Obviously, only a patient(s) can provide input on personal patient experiences and one patient cannot speak for all other patients. Most often, multiple, diverse and complementary types of patients and representatives are needed to really understand the patient, carer, and family experience. Patients, carers, and family members can speak to their own experiences and observations. Patient representatives from patient organizations can speak to their knowledge about the broader population, especially based upon registry, survey, and other sources of information about the organization’s constituents.

This document is intended to help define and clarify who and what is needed for various activities at various points in time. We suggest that anyone wanting to engage the patient community—including patients and patient groups themselves-begin by:

Defining the objective of the activity to be conducted (e.g., understand a patient’s lived experience with a disease, understand patient community-level needs, understand the burden of disease on carers, etc.) and the corresponding kind of patient input needed to meet that objective;
Determining the specific skills/experiences/expertise a patient or representative would be required to have to uniquely position them to contribute to the objective, especially when fulfilling the role of a patient partner; and
Considering additional skills/expertise/knowledge that are a “nice-to-have” but not required depending on the task. Clinicians, researchers, teachers, marketing experts, and people in any other lines of work are also often patients. It is critical to ensure that representation of the patient perspective is the primary role of the person serving as a patient partner and is not just occurring by happenstance.

For example, a patient recruited to be a patient partner in developing a PC-CIS might also be a communications expert. That person’s primary role is to represent the patient view, thought he/she might also provide advice on communicating information to patients as an aside. However, it would not be acceptable that the clinical researcher who is the principal investigator on a project, who also has a mild form of the disease in question, will also serve as the sole patient partner. This level of patient engagement and involvement would be insufficient.

An additional consideration is the role that trusted community leaders or champions may play in bringing forward the experiences, needs, and concerns of a population. Depending on the activity or objective, these community representatives may play roles similar to patient advocacy organization representatives, sharing population-level insights and needs, but not providing the unique lived experience of a patient unless they are also themselves a person with lived experience.

The following table provides terms, examples, and general expectations about potential skills to consider when preparing for engagement. Please note that in the table, the term “patient” could be substituted with carers and/or family members and can pertain to situations in which the carer or family member is providing insight as an observer of the patient (such as the parent of an infant), or as part of efforts to understand the burden of disease or treatment on the carer or family member themselves.

Patient and Patient Representatives: Examples of Types and Characteristics

Perspective and Type	Diabetes case example	Characteristics
		Personal lived experience with the disease or disorder e.g., has personal knowledge about living with the disease or disorder and treatments	Gained knowledge about disease population/ subpopulation through observation or training e.g., has knowledge of patients’ experiences, has knowledge about the disease in general	Patient-group staff (with content responsibility) e.g., has general knowledge about the disease and patients’ experiences from the lens of the organization	Other subject matter expertise (SME) through training* e.g., clinician, epidemiologist, clinical trialist, policy or regulatory expertise	Other subject matter expertise (SME) through experience* e.g., public speaking
PATIENT
Individual with disease, condition or disorder experience	An individual patient with a history of type II diabetes reports on their lived experience with the disease and offers ideas for how to make a clinical trial most feasible for someone like him/her	Yes	n/a	n/a	n/a	n/a
Individual patient with disease experience and subject matter expertise	An individual patient with a history of type II diabetes and works in a university setting conducting clinical trials; is asked to co-develop a clinical trial protocol for a new diabetes drug	Yes	n/a	n/a	Yes	n/a
Individual patient with disease experience and public speaking experience	An individual patient with a history of type II diabetes with a long career in television broadcasting serves as a moderator for a patient-focused drug development meeting (PFDD) on diabetes.	Yes	n/a	n/a	n/a	Yes
Individual patient with broader disease knowledge	An individual patient with a history of type II diabetes. This person has also been a volunteer with a local diabetes educational group and has gained broader knowledge about the disease and the experiences of others with diabetes. The person is invited to share the patient perspective at a roundtable based on her individual experience and that of many in her community.	Yes	Yes	n/a	n/a	n/a
Individual patient with broader disease knowledge and possesses additional expertise	An individual patient with a history of type II diabetes who has also been a volunteer with a local diabetes educational group and has general knowledge about the disease and the experiences of others with diabetes. The person is also a clinician and has communications and marketing experience. The individual is asked to lead a Patient-Centered Outcomes Research Institute (PCORI) project on effective patient/provider communication.	Yes	Yes	n/a	Yes	Yes
PATIENT AND PATIENT GROUP
Individual patient with disease experience and patient group representative	An individual patient with a history of type II diabetes reports on their lived experience with the disease. This person is a staff member at local American Diabetes Association (ADA)chapter and provides diabetes educational programs and has gained more general knowledge about the disease and the experiences of others with diabetes and has been involved in policy discussions about access to diabetes treatments.	Yes	Yes	Yes	n/a	n/a
Individual patient with disease experience, patient group representative and subject matter expertise (SME)/experience	An individual patient with a history of type II diabetes. This person is also a physician who works as the chief medical officer (CMO) at a patient organization and can speak to clinical, public health, and policy issues on diabetes.	Yes	Yes	Yes	Yes	Yes
PATIENT GROUP
Patient group representative	n individual with no history of type II diabetes. This person is a staff member at a local American Diabetes Association (ADA) chapter and provides diabetes educational programs and has gained broader knowledge about the disease and the experiences of others with diabetes and has been involved in policy discussions about access to diabetes treatments.	n/a	Yes	Yes	Yes	Yes

*not related to or derived from the individual’s specific disease experience

SME – subject matter expert/ise
ADA – American Diabetes Association
PFDD – Patient-focused drug development

X = the individual in the example demonstrates the qualities for this description
n/a = these specific characteristics are not relevant to or required

[i] National Health Council Glossary of Patient Engagement Terms, last accessed May 15, 2022. https://nationalhealthcouncil.org/additional-resources/glossary-of-patient-engagement-terms/