Guiding Principles

The multi-stakeholder team that co-developed the PC-CIS Blueprint established these Guiding Principles for its use:

• • The process begins by engaging patients (as well as carers and families) to identify what is important to them; they should be engaged at the earliest planning/buy-in stages and throughout.
  • At minimum, patients and patient groups are included as equal partners in all processes, with transparent decision-making and bi-directional communication.
  • Patients and patient groups must be in leadership and governance positions.
  • Patient-Centered Core Impact Set (PC-CIS) developers must strive to adhere to good health literacy and numeracy guidelines (see Supplemental Materials) and promote optimal accessibility and understandability.
  • Diversity and equity must be considered in all stages of PC-CIS development, methodology, and leadership (i.e., diversity in experiences, backgrounds, disease expression, sex and gender, sexual orientation, race, language, socioeconomic status, age, insurance type etc.).
  • PC-CIS developers must work toward developing methods for ensuring diversity and inclusion.
  • PC-CIS developers must strive for a robust co-production model in all prioritization processes. Items prioritized as important by patients cannot be eliminated, but all stakeholders have the ability to prioritize impacts important to them.
  • Any PC-CIS creation effort must be transparent, publicly accessible, and open source (e.g., posting of the process on a patient-group website).
  • PC-CIS are living documents that will evolve as new or different information develops (i.e., new methods, new data, previously untapped patient communities). This includes a commitment by the National Health Council (NHC) to maintaining the PC-CIS Blueprint.
  • PC-CIS are use agnostic. What is important to patients is important to them across all health care and research experiences. However, discrete measures used to capture individual core impacts must be appropriate or “fit for purpose” for the context of use. For example, an important impact that likely matters to patients across a variety of contexts is being unable to work due to disease activity or treatment effects. Exactly how inability to work is measured may need to differ depending on the context of use.
  • Processes for PC-CIS development should be flexible and not dependent on perfect data, methods, or conditions. Publication and sharing of limitations are essential to overall improvement, learning, and transparency