Developing an Initial Program Theory to Explain How Patient-Reported Outcomes Are Used in Health Care Settings: Methodological Process and Lessons Learned

A central aspect of any theory-driven realist investigation (synthesis or evaluation) is to develop an initial program theory (IPT). An IPT can be used to frame and understand how, for whom, why, and under what contexts complex interventions work or not. Despite well-established evidence that IPTs are a central aspect to any realist investigation, there is wide variation and a lack of methodological discussion on how to develop an IPT. In this article, we present the approach that we used to develop an IPT of how patient-reported outcomes (PROs) are used in health care settings. Specifically, we completed a systematic review to extract tacit theories reported in the literature. The benefit of this approach was that it provided a rigorous review of the literature in the development of IPTs. The challenges included (1) rediscovering what is already well established in the theoretical literature, (2) generating an overabundance of partial candidate theories, and (3) extensive use of time and resources for what was the first stage to our larger funded research study. Our recommendations to other scholars considering this approach are to ensure that they (1) live within their means and (2) narrow the scope of the research question and/or develop a conceptual framework using middle-range theories. These methodological insights are highly relevant to researchers embarking on a realist investigation, tasked with developing an IPT.