Towards the standardisation of adult person-reported outcome domains in diabetes research: A Consensus Statement development panel

Katharine Barnard-Kelly; David Marrero; Maartje de Wit; Frans Pouwer; Kamlesh Khunti; Norbert Hermans; Jessica S Pierce; Lori Laffel; Richard I G Holt; Tadej Battelino; Diana Naranjo; Jacqueline Fosbury; Lawrence Fisher; William Polonsky; Jill Weissberg-Benchell; Korey K Hood; Oliver Schnell; Laurel H Messer; Thomas Danne; Revital Nimri; Soren E Skovlund; Julia K Mader; Jennifer L Sherr; Desmond Schatz; Simon O'Neill; Emma Doble; Marissa Town; Karin Lange; Carine de Beaufort; Linda Gonder-Frederick; Sarah S Jaser; Alon Liberman; David Klonoff; Nuha A ElSayed; Raveendhara R Bannuru; Christopher G Parkin; Frank Snoek

doi:10.1111/dme.15332

Towards the standardisation of adult person-reported outcome domains in diabetes research: A Consensus Statement development panel

Diabet Med. 2024 May 15:e15332. doi: 10.1111/dme.15332. Online ahead of print.

Authors

Katharine Barnard-Kelly¹, David Marrero², Maartje de Wit³, Frans Pouwer^{4

5

6}, Kamlesh Khunti⁷, Norbert Hermans⁸, Jessica S Pierce⁹, Lori Laffel¹⁰, Richard I G Holt¹¹, Tadej Battelino¹², Diana Naranjo¹³, Jacqueline Fosbury¹⁴, Lawrence Fisher¹⁵, William Polonsky¹⁶, Jill Weissberg-Benchell¹⁷, Korey K Hood¹⁸, Oliver Schnell¹⁹, Laurel H Messer^{20

21}, Thomas Danne²², Revital Nimri^{23

24}, Soren E Skovlund²⁵, Julia K Mader²⁶, Jennifer L Sherr²⁷, Desmond Schatz^{28

29}, Simon O'Neill³⁰, Emma Doble³¹, Marissa Town³², Karin Lange³³, Carine de Beaufort³⁴, Linda Gonder-Frederick³⁵, Sarah S Jaser³⁶, Alon Liberman³⁷, David Klonoff³⁸, Nuha A ElSayed^{39

40}, Raveendhara R Bannuru⁴¹, Christopher G Parkin⁴², Frank Snoek^{43

44}

Affiliations

¹ BHR Ltd, Fareham, UK.
² University of Arizona, Tucson, Arizona, USA.
³ Amsterdam UMC, Amsterdam, The Netherlands.
⁴ Department of Psychology, University of Southern Denmark, Odense, Denmark.
⁵ Steno Diabetes Center Odense, Odense, Denmark.
⁶ Department of Medical Psychology, Amsterdam UMC, Amsterdam, The Netherlands.
⁷ University of Leicester, Leicester, UK.
⁸ Research Institute of the Diabetes Academy Mergentheim (FIDAM), Mergentheim, Germany.
⁹ Center for Healthcare Delivery Science, Nemours Children's Hospital, Orlando, Florida, USA.
¹⁰ Joslin Diabetes Center, Boston, Massachusetts, USA.
¹¹ University of Southampton, Southampton, UK.
¹² Faculty of Medicine, University Medical Center Ljubljana, University of Ljubljana, Ljubljana, Slovenia.
¹³ Stanford University School of Medicine, San Francisco, California, USA.
¹⁴ United Kingdom Council for Psychotherapy, London, UK.
¹⁵ University of California San Francisco, San Francisco, California, USA.
¹⁶ Behavioral Diabetes Institute, San Diego, California, USA.
¹⁷ Pritzker Department of Psychiatry and Behavioral Health, Northwestern University Feinberg School of Medicine, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, USA.
¹⁸ Department of Pediatrics, Division of Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, California, USA.
¹⁹ Forschergruppe Diabetes e. VMunich, Munich, Germany.
²⁰ Barbara Davis Center, University of Colorado, Boulder, Colorado, USA.
²¹ Tandem Diabetes Care, San Diego, California, USA.
²² Diabetes-Center for Children and Adolescents, Hannover, Germany.
²³ The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.
²⁴ Israel and Sacker Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
²⁵ Evidera, London, UK.
²⁶ Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
²⁷ Department of Pediatrics, Yale School of Medicine, Yale University, New Haven, Connecticut, USA.
²⁸ Diabetes Institute, University of Florida College of Medicine, Gainesville, Florida, USA.
²⁹ American Diabetes Association, Gainesville, Florida, USA.
³⁰ Diabetes UK, London, UK.
³¹ Patient Author, UK.
³² Children with Diabetes, Cincinnati Children's Hospital, Cincinnati, Ohio, USA.
³³ Hannover Medical School, Department Medical Psychology, Hannover, Germany.
³⁴ Centre Hospitalier de Luxembourg, GD de Luxembourg, Technology and Medicine, University of Luxembourg, Luxembourg, Belgium.
³⁵ Center for Diabetes Technology, Center for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia, Charlottesville, Virginia, USA.
³⁶ Vanderbilt University Medical Center, Department of Pediatrics, Nashville, Tennessee, USA.
³⁷ Jesse Z. and Sara Lea Shafer Institute of Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikvah, Israel.
³⁸ Mills-Peninsula Medical Center, San Mateo, California, USA.
³⁹ Health Care Improvement, American Diabetes Association, Arlington, Virginia, USA.
⁴⁰ Harvard Medical School, Boston, Massachusetts, USA.
⁴¹ Medical Affairs and QI Outcomes, American Diabetes Association, Arlington, Virginia, USA.
⁴² CGParkin Communications, Inc., Henderson, Nevada, USA.
⁴³ Amsterdam UMC, Vrije Universiteit Amsterdam, Medical Psychology, Amsterdam, The Netherlands.
⁴⁴ Amsterdam Public Health, Mental Health, Amsterdam, The Netherlands.

PMID: 38751219
DOI: 10.1111/dme.15332

Abstract

Diabetes is unique among chronic diseases because clinical outcomes are intimately tied to how the person living with diabetes reacts to and implements treatment recommendations. It is further characterised by widespread social stigma, judgement and paternalism. This physical, social and psychological burden collectively influences self-management behaviours. It is widely recognised that the individual's perspective about the impact of trying to manage the disease and the burden that self-management confers must be addressed to achieve optimal health outcomes. Standardised, rigorous assessment of mental and behavioural health status, in interaction with physical health outcomes is crucial to aid understanding of person-reported outcomes (PROs). Whilst tempting to conceptualise PROs as an issue of perceived quality of life (QoL), in fact health-related QoL is multi-dimensional and covers indicators of physical or functional health status, psychological and social well-being. This complexity is illuminated by the large number of person reported outcome measures (PROMs) that have been developed across multiple psychosocial domains. Often measures are used inappropriately or because they have been used in the scientific literature rather than based on methodological or outcome assessment rigour. Given the broad nature of psychosocial functioning/mental health, it is important to broadly define PROs that are evaluated in the context of therapeutic interventions, real-life and observational studies. This report summarises the central themes and lessons derived in the assessment and use of PROMs amongst adults with diabetes. Effective assessment of PROMs routinely in clinical research is crucial to understanding the true impact of any intervention. Selecting appropriate measures, relevant to the specific factors of PROs important in the research study will provide valuable data alongside physical health data.

Keywords: depression; distress; person‐reported outcomes; quality of life; treatment satisfaction; type 1 diabetes; type 2 diabetes.

Abstract

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