Exploring, describing, and mapping the constitutive elements of patient-reported outcomes (PROs) used in clinical practice

Abstract

Abstract
 Background: The functionality and purpose of patient-reported outcomes (PROs) have evolved as a result of their digitalisation and extended application in clinical practice. The diffusion of PROs on various organisational levels in different sectors and disease areas has further shaped their usage and construction. Thus, this paper identifies the main elements constituting a PRO in the context of clinical practice. The aim is to create a concept map (PRO Elements) grounded in the extant literature, translating, combining, and mediating different interpretations of PRO among stakeholders, to enhance users’ understanding and use of PROs with a particular focus on patient participation.
 Methods: The study is based on a systematic document analysis—a sub-study of an extensive scoping review (PubMed, Embase, CINAHL, Scopus) of PROs and patient participation in clinical practice.
 Results: The mapping of PRO reveals that, in clinical practice, a combination of eight main elements constitutes a PRO— validated questionnaire(s), developers, content, measures, mediation, respondents, data, and outcomes – forming the concept map called PRO Elements.
 Conclusion: The article provides an interdisciplinary mapping, presentation, and discussion of PROs’ constitutive elements, with an emphasis on patient participation. The holistic conceptualisation map illustrates various types of PROs that may prompt stakeholders to engage in discourse on the development, implementation, and evaluation of PROs to create more coherent and beneficial applications.