Towards standardization of person-reported outcomes (PROs) in pediatric diabetes research: A consensus report

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

5

6}, Kamlesh Khunti⁷, Norbert Hermans^{8

9}, Jessica S Pierce¹⁰, Lori Laffel¹¹, Richard I G Holt¹², Tadej Battelino¹³, Diana Naranjo¹⁴, Jacqueline Fosbury¹⁵, Lawrence Fisher¹⁶, William Polonsky¹⁷, Jill Weissberg-Benchell¹⁸, Korey K Hood¹⁹, Oliver Schnell²⁰, Laurel H Messer^{21

22}, Thomas Danne²³, Revital Nimri^{24

25}, Soren Skovlund²⁶, Julia K Mader²⁷, Jennifer L Sherr²⁸, Desmond Schatz²⁹, Simon O'Neill³⁰, Emma Doble³¹, Marissa Town³², Karin Lange³³, Carine de Beaufort³⁴, Linda Gonder-Frederick³⁵, Sarah S Jaser³⁶, Alon Liberman³⁷, David Klonoff³⁸, Nuha A Elsayed³⁹, Raveendhara R Bannuru⁴⁰, Ramzi Ajjan⁴¹, Christopher Parkin⁴², Frank J Snoek⁴³

Affiliations

¹ Southern Health NHS Foundation Trust, Southampton, UK.
² Indiana University School of Public Health, Bloomington, Indiana, USA.
³ Amsterdam UMC, Netherlands, Amsterdam Public Health, Mental Health, Amsterdam, the Netherlands.
⁴ Department of Psychology, University of Southern Denmark, Copenhagen, Denmark.
⁵ Steno Diabetes Center Odense, Odense, Denmark.
⁶ Department of Medical Psychology, Amsterdam UMC, Amsterdam, The Netherlands.
⁷ Diabetes Research Centre, University of Leicester, Leicester, UK.
⁸ Research Institute of the Diabetes Academy Mergentheim (FIDAM), Bad Mergentheim, Germany.
⁹ Department of Clinical Psychology and Psychotherapy, University of Bamberg, Bamberg, Germany.
¹⁰ Center for Healthcare Delivery Science, Nemours Children's Hospital, Orlando, Florida, USA.
¹¹ Joslin Diabetes Center, Inc., Boston, Massachusetts, USA.
¹² University of Southampton, Southampton, UK.
¹³ University Medical Center Ljubljana, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
¹⁴ Stanford University School of Medicine, Stanford, California, USA.
¹⁵ Psychotherapist, Brighton, UK.
¹⁶ University of California San Francisco, San Francisco, California, USA.
¹⁷ Behavioral Diabetes Institute, San Diego, California, USA.
¹⁸ Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
¹⁹ Division of Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, California, USA.
²⁰ Forschergruppe Diabetes e. V, Oberschleißheim, Germany.
²¹ Barbara Davis Center, University of Colorado, Aurora, Colorado, USA.
²² Tandem Diabetes Care, San Diego, California, USA.
²³ Breakthrough T1D, New York, New York, USA.
²⁴ 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.
²⁵ Israel and Sacker Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
²⁶ Evidera, London, UK.
²⁷ Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
²⁸ Department of Pediatrics, Yale School of Medicine, Yale University, New Haven, Connecticut, USA.
²⁹ Diabetes Institute, University of Florida College of Medicine Past President, American Diabetes Association, Arlington, Florida, USA.
³⁰ Diabetes UK, London, UK.
³¹ Patient author, Edinburgh, UK.
³² Children with Diabetes, Cincinnati Children's Hospital, Cincinnati, Ohio, USA.
³³ Department Medical Psychology, Hannover Medical School, Hannover, Germany.
³⁴ Centre Hospitalier de Luxembourg, Luxembourg, GD de Luxembourg, Technology and Medicine, University of Luxembourg, Esch-sur-Alzette, Luxembourg.
³⁵ Center for Diabetes Technology, Center for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia, Charlottesville, Virginia, USA.
³⁶ Department of Pediatrics, Vanderbilt University Medical Center, 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 Tikva, Israel.
³⁸ Mills-Peninsula Medical Center, Burlingame, California, USA.
³⁹ Health Care Improvement, American Diabetes Association, Harvard Medical School, Boston, Massachusetts, USA.
⁴⁰ Medical Affairs and QI Outcomes, American Diabetes Association, Arlington, Virginia, USA.
⁴¹ Leeds Diabetes Centre, Leeds, UK.
⁴² CGParkin Communications, Inc., Clark County, Nevada, USA.
⁴³ Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.

PMID: 39689218
DOI: 10.1111/dme.15484

Towards standardization of person-reported outcomes (PROs) in pediatric diabetes research: A consensus report

Katharine Barnard-Kelly et al. Diabet Med. 2025 Mar.

. 2025 Mar;42(3):e15484.

doi: 10.1111/dme.15484. Epub 2024 Dec 17.

Authors

Affiliations

¹ Southern Health NHS Foundation Trust, Southampton, UK.
² Indiana University School of Public Health, Bloomington, Indiana, USA.
³ Amsterdam UMC, Netherlands, Amsterdam Public Health, Mental Health, Amsterdam, the Netherlands.
⁴ Department of Psychology, University of Southern Denmark, Copenhagen, Denmark.
⁵ Steno Diabetes Center Odense, Odense, Denmark.
⁶ Department of Medical Psychology, Amsterdam UMC, Amsterdam, The Netherlands.
⁷ Diabetes Research Centre, University of Leicester, Leicester, UK.
⁸ Research Institute of the Diabetes Academy Mergentheim (FIDAM), Bad Mergentheim, Germany.
⁹ Department of Clinical Psychology and Psychotherapy, University of Bamberg, Bamberg, Germany.
¹⁰ Center for Healthcare Delivery Science, Nemours Children's Hospital, Orlando, Florida, USA.
¹¹ Joslin Diabetes Center, Inc., Boston, Massachusetts, USA.
¹² University of Southampton, Southampton, UK.
¹³ University Medical Center Ljubljana, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
¹⁴ Stanford University School of Medicine, Stanford, California, USA.
¹⁵ Psychotherapist, Brighton, UK.
¹⁶ University of California San Francisco, San Francisco, California, USA.
¹⁷ Behavioral Diabetes Institute, San Diego, California, USA.
¹⁸ Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
¹⁹ Division of Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, California, USA.
²⁰ Forschergruppe Diabetes e. V, Oberschleißheim, Germany.
²¹ Barbara Davis Center, University of Colorado, Aurora, Colorado, USA.
²² Tandem Diabetes Care, San Diego, California, USA.
²³ Breakthrough T1D, New York, New York, USA.
²⁴ 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.
²⁵ Israel and Sacker Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
²⁶ Evidera, London, UK.
²⁷ Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
²⁸ Department of Pediatrics, Yale School of Medicine, Yale University, New Haven, Connecticut, USA.
²⁹ Diabetes Institute, University of Florida College of Medicine Past President, American Diabetes Association, Arlington, Florida, USA.
³⁰ Diabetes UK, London, UK.
³¹ Patient author, Edinburgh, UK.
³² Children with Diabetes, Cincinnati Children's Hospital, Cincinnati, Ohio, USA.
³³ Department Medical Psychology, Hannover Medical School, Hannover, Germany.
³⁴ Centre Hospitalier de Luxembourg, Luxembourg, GD de Luxembourg, Technology and Medicine, University of Luxembourg, Esch-sur-Alzette, Luxembourg.
³⁵ Center for Diabetes Technology, Center for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia, Charlottesville, Virginia, USA.
³⁶ Department of Pediatrics, Vanderbilt University Medical Center, 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 Tikva, Israel.
³⁸ Mills-Peninsula Medical Center, Burlingame, California, USA.
³⁹ Health Care Improvement, American Diabetes Association, Harvard Medical School, Boston, Massachusetts, USA.
⁴⁰ Medical Affairs and QI Outcomes, American Diabetes Association, Arlington, Virginia, USA.
⁴¹ Leeds Diabetes Centre, Leeds, UK.
⁴² CGParkin Communications, Inc., Clark County, Nevada, USA.
⁴³ Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.

PMID: 39689218
DOI: 10.1111/dme.15484

Abstract

Background: Diabetes ranks among the most common chronic conditions in childhood and adolescence. It is unique among chronic conditions, in that clinical outcomes are intimately tied to how the child or adolescent living with diabetes and their parents or carers react to and implement good clinical practice guidance. It is widely recognized that the individual's perspective about the impact of trying to manage the disease together with the burden of self-management should be addressed to achieve optimal health outcomes. Standardized, rigorous assessment of behavioural and mental health outcomes is crucial to aid understanding of person-reported outcomes alongside, and in interaction with, physical health outcomes. Whilst tempting to conceptualize person-reported outcomes as a focus on perceived quality of life, the reality is that health-related quality of life is multi-dimensional and covers indicators of physical or functional health status, psychological well-being and social well- being.

Methods: In this context, this Consensus Statement has been developed by a collection of experts in diabetes to summarize the central themes and lessons derived in the assessment and use of person-reported outcome measures in relation to children and adolescents and their parents/carers, helping to provide a platform for future standardization of these measures for research studies and routine clinical use.

Results: This consensus statement provides an exploration of person-reported outcomes and how to routinely assess and incorporate into clincial research.

Keywords: T1D diabetes; adolescents; children; distress; patient‐reported outcomes; quality of life.

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References

REFERENCES

1. The effect of intensive treatment of diabetes on the development and progression of long‐term complications in insulin‐dependent diabetes mellitus. The diabetes control and complications trial research group. N Engl J Med. 1993;329:977‐986.
1. Effect of intensive diabetes treatment on the development and progression of long‐term complications in adolescents with insulin‐dependent diabetes mellitus: diabetes control and complications trial. Diabetes control and complications trial research group. J Pediatr. 1994;125:177‐188.
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1. Narayan KM, Gregg EW, Engelgau MM, et al. Translation research for chronic disease: the case of diabetes. Diabetes Care. 2000;23:1794‐1798.

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Towards standardization of person-reported outcomes (PROs) in pediatric diabetes research: A consensus report

Affiliations

Towards standardization of person-reported outcomes (PROs) in pediatric diabetes research: A consensus report

Authors

Affiliations

Abstract

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