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Epidemiology/Health Services Research
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
  1. Nicola L Harman1,
  2. John P H Wilding2,
  3. Dave Curry3,
  4. James Harris3,
  5. Jennifer Logue4,
  6. R John Pemberton3,
  7. Leigh Perreault5,6,
  8. Gareth Thompson3,
  9. Sean Tunis7,
  10. Paula R Williamson1
  11. on behalf of the SCORE-IT Study Team
    1. 1Department of Biostatistics, University of Liverpool, Liverpool, UK
    2. 2Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK
    3. 3University of Liverpool, Liverpool, UK
    4. 4Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK
    5. 5Division of Endocrinology, Metabolism and Diabetes, University of Colorado, Denver, Colorado, USA
    6. 6Colorado School of Public Health, Aurora, Colorado, USA
    7. 7Center for Medical Technology Policy (CMTP), Baltimore, Maryland, USA
    1. Correspondence to Dr Nicola L Harman; n.harman{at}liverpool.ac.uk

    Abstract

    Objectives Heterogeneity in outcomes measured across trials of glucose-lowering interventions for people with type 2 diabetes impacts on the ability to compare findings and may mean that the results have little importance to healthcare professionals and the patients that they care for. The SCORE-IT study (Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 diabetes) has addressed this issue by establishing consensus on the most important outcomes for non-surgical interventions for hyperglycemia in type 2 diabetes.

    Research design and methods A comprehensive list of outcomes was developed from registered clinical trials, online patient resources, qualitative literature and long-term studies in the field. This list was then scored in a two-round online Delphi survey completed by healthcare professionals, people with type 2 diabetes, researchers in the field and healthcare policymakers. The results of this online Delphi were discussed and ratified at a face-to-face consensus meeting.

    Results 173 people completed both rounds of the online survey (116 people with type 2 diabetes, 37 healthcare professionals, 14 researchers and 6 policymakers), 20 of these attended the consensus meeting (13 people with type 2 diabetes and 7 healthcare professionals). Consensus was reached on 18 core outcomes across five domains, which include outcomes related to diabetes care, quality of life and long-term diabetes-related complications.

    Conclusions Implementation of the core outcome set in future trials will ensure that outcomes of importance to all stakeholders are measured and reported, enhancing the relevance of trial findings and facilitating the comparison of results across trials.

    • Type 2 diabetes
    • randomized clinical trials
    • outcomes
    • outcomes research

    This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

    https://doi.org/10.1136/bmjdrc-2019-000700

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      Footnotes

      • Collaborators Collaborating authors, part of the SCORE-IT Study Team: Serena Battaglia, Florence Bietrix, Jacques Demotes-Mainard, Valerie Gailus-Durner, Silvio Garattini, Tim Moser, Cecilia A C Prinsen, Michael Raess, Adrian Sanz-Moreno, Caroline B Terwee.

      • Contributors PRW and NLH conceived and designed the study, and as the study management group were responsible for the day-to-day running of the project. NLH drafted the manuscript; all authors reviewed and approved the final manuscript. All authors contributed to the review of the study design and to the review and analysis of study data. DC, GT, JH and RJP are volunteers of Diabetes UK who sit on the Study Steering Committee and who have provided an invaluable patient perspective for all aspects of the study. JPHW, JL and LP provided clinical input. As the corresponding author, NLH acts as guarantor for this study and has had full access to the data, final responsibility for the content of this article and the decision to submit for publication.

      • Funding This work has received funding from the European Union’s Horizon 2020 research and innovation program (CORBEL, under grant agreement no 654248).

      • Competing interests PRW is a member of the COMET Management Group. JPHW has received funding (grant income, personal fees and consultancy fees) from Astellas, AstraZeneca, Boehringer Ingelheim, Janssen Pharmaceuticals, Napp, Mundipharma, Novo Nordisk, Sanofi, Takeda and Wilmington Healthcare. All other authors declare they have no competing interests.

      • Patient consent for publication Not required.

      • Ethics approval Ethical approval was obtained from the University of Liverpool Research Ethics Committee prior to undertaking the consensus methods (online Delphi and consensus meeting) (ref: 3306).

      • Provenance and peer review Not commissioned; externally peer reviewed.

      • Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.