Background

The following figure illustrates the different areas:

Figure 2: Levels of core outcome sets

We chose PROMIS  (Patient-Reported Outcomes Measurement Information System)  to structure outcome areas and domains considering a biopsychosocial conceptual framework.

PROMIS conceptual framework of health

The PROMIS-Model is a formal Model aiming to categorize the complex area of (self-reported) health in different sub-areas. Based on the biopsychosocial understanding of health, the complex construct of (self-reported) health is divided into three areas: physical, mental, and social health. As shown in Figure 1, the three areas of health can be furthermore divided into domains.

Figure 1: PROMIS conceptual framework of health

In addition, domains are divided into subdomains (cf. Figure 2). Given the described differentiation of the more or less abstract term of (self-reported) health in domains and subdomains, measurable single constructs can be defined. On the basis of subdomains, core outcome sets can be developed.

Figure 2: Domains and subdomains

Idzerda L, Rader T, Tugwell P, Boers M. Can We Decide Which Outcomes Should Be Measured in Every Clinical Trial? A Scoping Review of the Existing Conceptual Frameworks and Processes to Develop Core Outcome Sets. J Rheumatol. 2014