<p>Developing a Preliminary Conceptual Framework for Guidelines on Inclusion of Patient Reported-Outcome Measures (PROMs) in Clinical Quality Registries</p>

Abstract

PurposePatient-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.MethodsThis 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.ResultsContent 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.ConclusionWe 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.

Preliminary development of recommendations for the inclusion of patient-reported outcome measures in clinical quality registries

“…The recommendations embedded within the domains of the recently published PROMs conceptual framework [ 16 ] are summarised below.…”

“…A list of preliminary statements for the recommendations was based on the literature review and a survey of existing Australian registries, conducted in 2019 [ 16 ]. A total of 3661 articles published between July 2018 and September 2018 were identified.…”

“…The statements arising from the literature review and survey responses were grouped into a conceptual framework that included the following domains: rationale, setting, ethics, instrument, administration, data management, statistical methods, and feedback/reporting of the PROMs data [ 16 ]. Each of the domains were further divided into categories, with the relevant recommendations.…”

“…The above listed guides provide recommendations for clinicians capturing PROMs data in clinical practice and to tailor care to individual needs. Clinical registries play an increasingly important role as a stimulus for quality improvement by providing high-quality data and analyses that are respected by clinicians [ 15 , 16 ]. PROMs in CQRs are used for reporting and benchmarking purposes [ 16 , 17 ].…”

“…Clinical registries play an increasingly important role as a stimulus for quality improvement by providing high-quality data and analyses that are respected by clinicians [ 15 , 16 ]. PROMs in CQRs are used for reporting and benchmarking purposes [ 16 , 17 ]. Implementation of lessons learned from CQRs that include PROMs will assure patients achieve optimal management of the disease and functional gain with minimal adverse events [ 9 ].…”