Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 diabetes (SCORE-IT): a patient and healthcare professional consensus on a core outcome set for type 2 diabetes

Harman, Nicola; Wilding, John; Curry, Dave; Harris, James; Logue, Jennifer; Pemberton, R. John; Perreault, Leigh; Thompson, Gareth; Tunis, Sean; Williamson, Paula; Team, Score-It Study

doi:10.1136/bmjdrc-2019-000700

Cited by 48 publications

(55 citation statements)

References 40 publications

(48 reference statements)

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“…Type 2 diabetes (T2D) was an opportunistic choice for our exemplar clinical area because the authors were concurrently involved in COS, trial and EHR research activity relating to T2D, namely in the development of the SCORE-IT COS [20] and in the DECIDE trial [21]. The SCORE-IT COS is the only published COS for T2D research, and was the first COS for research to follow the Core Outcome Set-STAndards for Development (COS-STAD) [22] minimum standards, which cover 11 key features of COS development relating to three aspects of the COS development process: scope (including the health condition, population and intervention covered by the COS), stakeholder involvement (including patients, healthcare professionals and researchers) and consensus process (relating to the initial outcomes lists, scoring and consensus decisions, and unambiguous wording of outcomes).…”

Section: Exemplar Case Studymentioning

confidence: 99%

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

Harman

Taske²,

Minchin³

et al. 2020

Trials

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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.

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Section: Exemplar Case Studymentioning

confidence: 99%

“…Type 2 diabetes (T2D) was chosen as the exemplar clinical area for this case study because the authors were involved in COS, trial and EHR research activity relating to T2D. First, we identified and extracted the core outcomes from the only published COS for research relating to T2D, SCORE-IT [20].…”

Section: Cos For Research In Type 2 Diabetes (T2d)mentioning

confidence: 99%

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

Harman

Taske²,

Minchin³

et al. 2020

Trials

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“…Outcomes were then compared to those identified from a previous review of phase 3/4 registered clinical trials [21] and to those included in the core outcome set for type 2 diabetes [22].…”

Section: Comparison With Clinical Trialsmentioning

confidence: 99%

“…Their purpose is to reduce the heterogeneity in outcomes measured in clinical trials of a particular condition, facilitate evidence synthesis, and promote the measurement of outcomes relevant to all stakeholders. A COS for glucose lowering interventions for type 2 diabetes has been developed [22] and the outcomes measured pre-clinically were compared to this. The core outcome set includes 18 outcomes, and of these 17 could potentially be measured in a mouse model.…”

Section: Comparison With An Existing Core Outcome Setmentioning

confidence: 99%

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Can harmonisation of outcomes bridge the translation gap for pre-clinical research? A systematic review of outcomes measured in mouse models of type 2 diabetes

Harman

Sanz-Moreno²,

Παπουτσοπουλου

et al. 2020

J Transl Med

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Background In pre-clinical research, systematic reviews have the potential to mitigate translational challenges by facilitating understanding of how pre-clinical studies can inform future clinical research. Yet their conduct is encumbered by heterogeneity in the outcomes measured and reported, and those outcomes may not always relate to the most clinically important outcomes. We aimed to systematically review outcomes measured and reported in pre-clinical in vivo studies of pharmacological interventions to treat high blood glucose in mouse models of type 2 diabetes. Methods A systematic review of pre-clinical in vivo studies of pharmacological interventions aimed at addressing elevated blood glucose in mouse models of type 2 diabetes was completed. Studies were screened for eligibility and outcomes extracted from the included studies. The outcomes were recorded verbatim and classified into outcome domains using an existing outcome taxonomy. Outcomes were also compared to those identified in a systematic review of registered phase 3/4 clinical trials for glucose lowering interventions in people with type 2 diabetes. Results Review of 280 included studies identified 532 unique outcomes across 19 domains. No single outcome, or domain, was measured in all studies and only 132 (21%) had also been measured in registered phase 3/4 clinical trials. A core outcome set, representing the minimum that should be measured and reported, developed for type 2 diabetes effectiveness clinical trials includes 18 core outcomes, of these 12 (71%) outcomes were measured and reported in one or more of the included pre-clinical studies. Conclusions There is heterogeneity of outcomes reported in pre-clinical research. Harmonisation of outcomes across the research pathway using a core outcome set may facilitate interpretation, evidence synthesis and translational success, and may contribute to the refinement of the use of animals in research. Systematic review registration: The study was prospectively registered on the PROSPERO Database, registration number CRD42018106831

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Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes

Natale,

Tunnicliffe,

Toyama

et al. 2024

Cochrane Database of Systematic Reviews

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Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 diabetes (SCORE-IT): a patient and healthcare professional consensus on a core outcome set for type 2 diabetes

Cited by 48 publications

References 40 publications

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

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

Can harmonisation of outcomes bridge the translation gap for pre-clinical research? A systematic review of outcomes measured in mouse models of type 2 diabetes

Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes

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