The National Health Council (NHC) and its partners have undertaken the creation of a Blueprint for developing “patient-centered core impact sets,” or PC-CIS, to address inconsistencies between what is important to patients* versus much of the information that is typically collected in research and care.
A PC-CIS is a patient-derived and -prioritized list of impacts a disease and/or its treatments have on a patient* and their life as well as that of their family and caregivers.
Intentionally broad and inclusive, the term “impacts” includes short- and long-term health outcomes and any other related implications (e.g., mental health effects, caregiver/family stresses, economic burden, work, and career loss, etc.).
*Throughout the Blueprint, the term “patient” can be used to include carers and families as is appropriate.
As reflected in this graphic, the Blueprint differs markedly from past efforts to create core sets. While other initiatives begin with a review of the existing research and often an environmental scan, the PC-CIS Blueprint starts with insights and data generated directly by and from patients. Learnings from literature and other stakeholders are important, but come later in the process, helping to further flesh out the impact set, but never supplanting the impacts reported as most important to patients. A key consideration for use of the Blueprint is efficiency; drawing from existing materials to inform the work without replacing the patient-prioritized information.
The focus of a PC-CIS is the collection and prioritization of core, patient-reported/prioritized impacts. This core informs downstream decisions on development of measures or tools. The focus here is not to zero in on measurement tools upfront. The identification, adaptation, or creation of measures is envisioned as downstream, after the PC-CIS is created. The PC-CIS is a precursor that informs measure creation or selection. Thus, the creation of tools is not covered here or under the resources and guidance provided within the Blueprint.
For a quick reference guide about the steps in and use of the Blueprint, please see the Blueprint Checklist. As described there, the three activities outlined in the Planning Phase are intended to occur in tandem. Starting with the second phase, Gathering Data, each step is intended to be sequential, not co-occurring.
An Intentional Process to Support Patient Centricity
It is important to stop here and comment on the intentional order of data collection outlined in this Blueprint and noted in the overview figure on the process. You will see that gathering data on impacts from patients and prioritizing the patient-reported data precedes the environment scan and the collection of data from other stakeholders. This order is intentional to reduce bias. The rationale is to keep the data collected from and prioritized by patients free from the potential influence of past or current efforts that may dictate what the most important impacts should be.
For example, suppose the creation of a PC-CIS began with an environmental scan of the literature which produces a list of impacts assumed to be the most important to patients because of the frequency with which they appear in clinical-trial literature. However, the patients who participated in those trials were never asked what was important to them. The trial outcomes and endpoints reflect only the views of the clinical researchers. Thus, if such a list were used as a starting point, it could bias the insights and data provided by patients or their perspectives in the prioritization processes.
For this reason, two separate data gathering efforts happen, one from patients and one from other sources (other stakeholders and the environmental scan). All impact data is then combined in the second, overall prioritization process. Two important considerations happen in this second prioritization: 1. All evidence on all important impacts is provided from all sources to all participants, and 2. The patient-prioritized impacts are protected from elimination throughout the process.
Must the data gathering be done sequentially? The two data gathering steps could be done in tandem if it can be assured that the patient data collection is not biased by the data from the other sources. This is likely very difficult to do. The prioritization processes should be kept separate to avoid influencing patient prioritization.
Blueprint: What, Who, and Why?
A Step-by-Step Process
The Blueprint offers a step-by-step process for making use of and best understanding the knowledge patients and families have about the impacts of disease and treatment. Only patients can tell us about their lived experiences and what is most important them. But not all patients, even within the same disease community, will have the same experiences and priorities. Using sound, representative patient engagement methods can help to provide the foundation for identifying and prioritizing the impacts of most concern.
Patient Organizations and Others in the Patient Community
This Blueprint is intended for patient organizations and others interested in developing a disease- or population- specific PC-CIS. It will help guide them through the phases of developing a PC-CIS but is not a substitute for partnering with experienced researchers and experts as needed. It is intended to be a flexible guide and not overly prescriptive. We have attempted to glean best practices based on existing work and past experiences, and provide citations and links to those useful resources. We acknowledge there are gaps in knowledge and in those cases, we have attempted to fill those gaps with practical advice and considerations in this evolving field.
A PC-CIS Capturing the Patient Voice for Downstream Uses
The creation of a disease- or population-specific PC-CIS could be valuable for a number of purposes, including, but not limited to, planning for and conducting a clinical research project, revising or creating clinical practice guidelines, developing methods for tracking and measuring quality of care, value and health technology assessment projects and analyses, and many other activities or initiatives in the health care and research ecosystem. This Blueprint is just that—a guide or a map to navigate the process. However, the Blueprint itself is disease and population agnostic, meaning the users will need to adapt and modify as needed to best fit their unique needs and goals, populations and subpopulations, and disease nuances.