PC-CIS Impact Taxonomy
Table of Contents
References………………………………………………………………..………………………………………………………..……………………2
Taxonomy Table………………………………………………………..……………………………………………………….………………….3
Modifying Factors………………………………………………..…..……………………………….………………………………………….4
References
The Patient-Centered Core Impact Sets (PC-CIS) taxonomy of impacts was developed based upon a number of existing tools (referenced below) and includes impact categories derived from those prior efforts, but also impacts that may be considered novel. With the goal of comprehensively capturing the full range of potential impacts most important to patients, this taxonomy will likely evolve through its ongoing use, meaning additional subcategories or additional layers of subcategories will be added over time. The National Health Council and other stakeholders will provide updates in the future as this evolution happens and stakeholders contribute learning.
Sources used to derive the taxonomy:
Brown D, Srinivasan M, Arbulu L, Dullabh P, Curtis K, Zott C, and Smith SR. Federal Data for Conducting Patient-Centered Outcomes Research on Economic Outcomes. Report commissioned by the HHS Assistant Secretary for Planning and Evaluation. https://aspe.hhs.gov/reports/data-pcor-economic-outcomes
Dodd S, Clarke M, Becker L, Mavergames C, Fish R, Williamson PR. A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery. J Clin Epidemiol. 2018;96:84-92. doi:10.1016/j.jclinepi.2017.12.020
dosReis S, Butler B, Caicedo J, Kennedy A, Hong YD, Zhang C, Slejko JF. Stakeholder-Engaged Derivation of Patient-Informed Value Elements. Patient. 2020 Oct;13(5):611-621. doi: 10.1007/s40271-020-00433-8. PMID: 32676998; PMCID: PMC7479003.
Innovation & Value Initiative. Open-Source Value Project Model for Major Depressive Disorder Health Economic Module: Draft Protocol. November 2021. Accessed May 11, 2022 from: https://www.thevalueinitiative.org/wp-content/uploads/2021/12/MDD-Model-Protocol-Draft.pdf
Yang G, Cintina I, Pariser A, Oehrlein E, Sullivan J, Kennedy A. The national economic burden of rare disease in the United States in 2019. Orphanet J Rare Dis. 2022;17(1):163. Published 2022 Apr 12. doi:10.1186/s13023-022-02299-5
Taxonomy Table
Impact Categories | Subcategories | Indicate Treatment-related, disease-related, or Both |
Symptoms* | Patient reported | |
Signs: Observed (by clinicians or others) | Patient reported | |
Clinician reported | ||
Other reported | ||
Performance | ||
Biomarkers | Physiologic | |
Laboratory | ||
Radiologic | ||
Function | Physical | |
Emotional | ||
Social | ||
Role | ||
Cognitive | ||
Length of life | Length of survival | |
Death | ||
Progression-free survival | ||
Overall Health-related Wellbeing/Quality of Life | Global wellbeing/quality of life | |
Perceived health status | ||
Health system experiences | Convenience | |
Preference (Tradeoffs) | ||
Satisfaction | ||
Bias or discrimination | ||
Treatment experiences | Convenience | |
Preference (Tradeoffs) | ||
Satisfaction | ||
Tolerance | ||
Benefit/risk preference | ||
Bias | ||
Resource use | Out-of-pocket | |
Direct medical costs | ||
Direct non-medical costs | ||
Indirect/ productivity costs | ||
Impacts on Others | Carer | |
Family | ||
Society |
*The distinction between symptoms and signs is based on the U.S. Food and Drug Administration (FDA) definitions for Patient-Reported Outcomes (PROs) and Observer-Reported Outcomes (ObsROs). Symptoms are things that only a patient can feel and report, like pain. Signs can be observed by people other than the patient. While a parent or caregiver can observe the patient and infer that a symptom exists, such as a child’s behavior changes secondary to pain, only the patient themselves can report symptoms.
Modifying Factors
Modifying factors are not impacts but may have an influence on disease- or treatment-related impacts. These may include but are not limited to:
- Social determinants of health
- Patient demographics
- Patient diagnostic journey
- Patient treatment journey
- Other conditions the patient has