Key concepts and background

Health organizations often rely on governance strategies (see box, Defining ePRO governance) to manage and formalize policies for the adoption and use of institutional resources. Establishing a structure for governing the electronic capture of patient-reported outcomes (ePROs) supports the needs of multiple stakeholders to design, implement, evaluate, and ultimately sustain ePRO measurement across the health system.

Some best practices exist for governance of information technology (IT) resources in health systems (AHIMA, 2017), as well as for the security and coordination of data infrastructure for single or multi-institutional medical research (McGraw & Leiter, 2013). However, little guidance is available to support the implementation of ePROs (as well as the implementation of broader digital patient-generated health data [PGHD]) across a health system. The purpose of this chapter is to convey the priority governance principles and activities that health systems can adopt to effectively plan for and manage both the technical and human factors of ePRO implementation.

Why ePRO governance?

An organization may decide to establish (or expand on existing) ePRO governance when there is an increasing demand for health IT resources across different stakeholder groups and clinical settings that would benefit from oversight and policies. Institutional resources (including health IT) require standards to scale efficiently across a health system, as the potential exists for redundancy and one-off projects when multiple needs for the same data exist. Governance introduces a platform to establish infrastructure standards, leverage implementation best practices, and engage stakeholders in decision-making processes.

What does ePRO governance include?

Governance can follow different models (e.g., a single steering committee or multiple bodies) and serve different purposes in various contexts (e.g., selection of patient reported outcome measures (PROMs) to develop into ePRO tools) (Biber et al, 2018; Gerhardt et al, 2018; Papuga et al, 2017). Thus, what a governance structure looks like and how it functions will vary across different organization types and settings. Governance structures, at the basic level, aim to provide oversight and supervision to support the management of ePRO implementations. As discussed in the guidelines that follow, at minimum, ePRO governance should include the following:

• multidisciplinary membership
• clarity on scope of work guided by standards and policies
• clarity on decision-making and oversight that fall within the governing body’s remit including sponsorship by an organizational champion

The governance guidelines: What to expect

The guidelines in this chapter are intended to support healthcare organizations develop or expand their enterprise ePRO initiatives. Governance must balance both the technical ramifications of ePRO implementations (i.e., how will IT support ePRO functionality) and the clinical consequences (i.e., how will ePROs support patient care). Therefore, the critical role of multi-disciplinary stakeholder engagement is echoed within each of the guidelines.

The first two guidelines describe the fundamental principles of goal setting and strategizing when planning for ePRO implementation, regardless of scale and purpose. The remaining three guidelines provide tangible strategies to develop and sustain governance, adhering to the principles presented in the first two guidelines throughout the governance journey. Collectively, these guidelines are intended to be flexible in nature, acknowledging that there is no one-size-fits-all approach to governance and that health systems will be at different starting points. These guidelines offer a strategic resource to navigate core dimensions and establish effective governance throughout the ePRO implementation journey.

In addition to the references cited throughout this section, we have provided an additional Supplemental Bibliography of resources that informed this work and may be useful to readers.