Abstract
PURPOSE: Patient-centred and value-based health-care organisations are increasingly recognising the importance of the patient perspective in the measurement and evaluation of health outcomes. This has been primarily implemented using patient-reported outcome measures (PROMs). Clinical quality registries (CQRs) are specifically designed to improve direct clinical care, benchmark health-care provision and inform health service planning and policy. Despite CQRs having incorporated the patient perspective to support the evaluation of health-care provision, no evidence-based guidelines for inclusion of PROMs in CQRs exist. This has led to substantial heterogeneity in capturing and reporting PROMs within this setting. This publication is the first in a series describing the development of evidence-informed guidelines for PROMs inclusion within CQRs in Australia. METHODS: This study consisted of three components: 1) a literature review of existing evidence of guidelines, enablers, barriers, and lessons learnt of PROMs use within the CQRs setting; 2) a survey of Australian CQRs to determine current practices for PROMs use and reporting; and 3) development of a preliminary conceptual framework for PROMs inclusion in CQRs. RESULTS: Content analysis of the literature review and survey of 66 Australian registries elicited eight categories for the conceptual framework. The framework covers eight components: rationale, setting, ethics, selection of PROMs, administration, data management, statistical methods, feedback, and reporting. CONCLUSION: We developed a preliminary conceptual framework, which classified findings, from both the literature and the survey, into broad categories ranging from initial development to outcome dissemination providing the structure for development of guidelines in the next phase of this project, engaging national and international leaders in health-related quality of life research, clinicians, researchers, patient advocates and consumers.