Creating and Ensuring Transparency

Standards it is critical that methods used to develop or update Patient-Centered Core Impact Sets (PC-CIS) be transparent, particularly when it comes to patient centricity. It must be clear:

• Who: Who was engaged in the process,
• How: How they were engaged, and
• When: When they were engaged, and at what time points throughout.

All stakeholders involved and their contributions should be acknowledged. Methods for collecting and analyzing data, prioritization and consensus building processes, and other actions should be clear and provide enough detail that a reader can assess the soundness and rationale.

Documentation of Methods

It is also important that documentation of methods be planned for in advance to ensure completeness, accuracy, consolidation, and transparency. Policies should be in place to ensure document storage and retention so that a PC-CIS can be assessed by all potential users and those who will add information in the future.

Potential resources include:

• for developing a Core Outcome Set (COS) which can provide a sense of the types of activities and practices important to include
• Standards for maintaining transparency in the reporting of the development of a COS can be useful for ensuring transparency in the development of a PC-CIS
• Innovation and Value Initiative (IVI) Open Source principles on how to transparently and accessibly communicate
• The International Society for Pharmacoeconomics and Outcomes Research (ISPOR)  Open Source Models Special Interest Group (SIG) publications and convening on barriers and facilitators to transparently sharing methods and processes

Setting Clear Expectations for PC-CIS Creation

The exact timeline for creating a PC-CIS depends on many factors, including the availability of existing data, and the relative size and experience of the patient group and other stakeholders assembled to develop the set. Creating a fully formed PC-CIS requires completing each of the steps laid out in this Blueprint, some of which may be labor intensive and time consuming. 

However, the final PC-CIS is not the only deliverable that will result from following this Blueprint. It may be helpful for Blueprint users to make potential downstream partners aware that while the ultimate product will take time, the interim deliverables will be available along the way, some of which are described here.

Arthritis Use Cases

• Throughout each phase of the project, decisions were made in partnership with various patient staff members and patient/parent volunteers.