Core outcome sets through the healthcare ecosystem: the case of type 2 diabetes mellitus

Abstract

Background: It is increasingly accepted that insufficient attention has been given to the patient health outcomes that are important to measure in comparative effectiveness research that will inform decision-making. The relationship between outcomes chosen for comparative effectiveness research, outcomes used in decision-making in routine care, and outcome data recorded in electronic health records (EHR) is also poorly understood. The COMET Initiative (http://www.comet-initiative.org/. Accessed 3 Apr 2020) supports and encourages the development and use of 'core outcome sets' (COS), which represent the minimum set of patient health outcomes that should be measured and reported for a specific condition. There is growing interest in identifying how COS might fit into the different stages of the healthcare research and delivery ecosystem, and whether inclusion in the EHR might facilitate this. Methods: We sought to determine the degree of overlap between outcomes within COS for research and routine care, EMA, FDA and NICE guidelines, NICE quality statements/indicators, EHR and a point-of-care randomised clinical trial, using type 2 diabetes (T2D) as a case study. Results: There is substantial agreement about important patient outcomes for T2D for research and healthcare, with associated coverage within the UK general practice EHR. Conclusions: This case study has demonstrated the potential for efficient research and value-based healthcare when the EHR can include COS for both research and care, where the COS comprises outcomes of importance to all relevant stakeholders. However, this concordance may not hold more generally, as the focus on patient-centred outcomes may well be greater in T2D than in other conditions. Work is ongoing to examine other clinical areas, in order to highlight any current inefficiencies when health outcomes in research and healthcare do not agree with core outcomes identified by patients, clinicians and other key stakeholders.

Choosing important health outcomes for comparative effectiveness research: 6th annual update to a systematic review of core outcome sets for research

“…COS can be developed for research, routine care, or both. While the focus of this review is COS for research, there is current interest in identifying whether COS might have a role throughout the healthcare research ecosystem [ 20 ]. In the previous update to this review, we highlighted the percentage of COS for research that also intend their recommendations for use in routine care had remained constant at around 11% [ 6 ].…”

More than half of systematic reviews have relevant core outcome sets

“…For example, for the topic of rheumatoid arthritis, we considered “disease activity” and “joint damage” to be outcomes that were generally matched because disease activity includes joint damage but can also include outcomes other than joint damage. We defined specific matches as scenarios in which one outcome was related to the other exactly, for example, “overall survival” and “all-cause mortality.” Our approach to determining the type of match for pairs of outcomes is consistent with an approach that has been described previously [14] .…”

“…We defined specific matches as scenarios in which one outcome was related to the other exactly, for example, "overall survival" and "all-cause mortality." Our approach to determining the type of match for pairs of outcomes is consistent with an approach that has been described previously [14] .…”

Comprehensive Assessment of Incidence, Risk Factors, and Mechanisms of Impaired Medical and Psychosocial Health Outcomes among Adolescents and Young Adults with Cancer: Protocol of the Prospective Observational COMPRAYA Cohort Study

“…Up to now most core outcome sets focus on specific diseases and not on age-related outcomes. The establishment of an international standard to align existing and newly developing research and healthcare initiatives would ease implementation and unlock far greater global collaboration to deliver better care at lower cost [ 70 ]. We acknowledge that collection of a standard set requires significant upfront investment in information technology and/or data collection resources.…”