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

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.

Contributors

Susanna Dodd, Nicola Harman, Nichole Taske, Mark Minchin, Toni Tan & Paula R. Williamson

Publication

Journal: Trials
Volume: 21
Issue: 570
Pages: -
Year: 2020
DOI: https://doi.org/10.1186/s13063-020-04403-1

Further Study Information

Current Stage: Completed
Date:
Funding source(s): None


Health Area

Disease Category: Endocrine & metabolic

Disease Name: Type 2 Diabetes

Target Population

Age Range: Unknown

Sex:

Nature of Intervention:

Stakeholders Involved

Study Type

- COS methods research

Method(s)

- Other

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.