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