Journal Article

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

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

2020

Overview

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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Big data for randomized trials / Biomedical Research - methods / Biomedical Research - standards / Biomedicine / Case studies / Clinical guidelines / Clinical medicine / Clinical practice guidelines / Clinical trials / Commentary / Comparative analysis / Consensus / Core outcome sets / Decision making / Diabetes / Diabetes Mellitus, Type 2 - diagnosis / Diabetes Mellitus, Type 2 - therapy / Ecosystems / Electronic health records / Electronic Health Records - standards / Electronic records / Endpoint Determination - methods / Endpoint Determination - standards / Foot diseases / Health Sciences / Humans / Medical records / Medical research / Medicine / Medicine & Public Health / Outcome Assessment, Health Care - methods / Outcome Assessment, Health Care - standards / Patient outcomes / Patients / Practice Guidelines as Topic / Quality improvement / Quality indicators / Quality Indicators, Health Care / Quality standards / Research Design - standards / Statistics for Life Sciences / Type 2 diabetes / Value-based care