Defining patient-reported outcomes in diabetes, obesity, cardiovascular disease, and chronic kidney disease for clinical practice guidelines - perspectives of the taskforce of the Guideline Workshop

Katharine Barnard-Kelly^{1

2}, Tadej Battelino^{3

4}, Frank C Brosius⁵, Antonio Ceriello⁶, Francesco Cosentino⁷, James R Gavin 3rd⁸, Francesco Giorgino⁹, Jennifer Green¹⁰, Linong Ji¹¹, Monika Kellerer¹², Sue Koob¹³, Mikhail Kosiborod¹⁴, Nebojsa Lalic¹⁵, Nikolaus Marx¹⁶, Prashant Nedungadi¹⁷, Christopher G Parkin¹⁸, Helena W Rodbard¹⁹, René D Rötzer²⁰, Lars Rydén²¹, Wayne Huey-Herng Sheu²², Eberhard Standl²³, Britta Tendal Jeppesen²⁴, Pinar Topsever²⁵, Per Olav Vandvik²⁶, Christoph Wanner²⁷, Oliver Schnell²⁸

Affiliations

¹ Southern Health NHS Foundation Trust, Southampton, UK.
² Spotlight-AQ Ltd, Fareham, UK.
³ University Medical Center, Ljubljana, Slovenia.
⁴ Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
⁵ University of Arizona College of Medicine, Tucson, AZ, USA.
⁶ IRCCS MultiMedica, Via Milanese 300, Milan, Italy.
⁷ Cardiology Unit, Department of Medicine, Karolinska Institute, Karolinska University Hospital, Solna, Stockholm, Sweden.
⁸ Emory University School of Medicine, Atlanta, GA, USA.
⁹ Department of Precision and Regenerative Medicine and Ionian Area, Section of Internal Medicine, Endocrinology, Andrology and Metabolic Diseases, University of Bari Aldo Moro, Bari, Italy.
¹⁰ Duke University Medical Center, Duke Clinical Research Institute, Durham, NC, USA.
¹¹ Peking University People's Hospital, Beijing, China.
¹² Marienhospital Stuttgart, Stuttgart, Germany.
¹³ PCNA National Office, Madison, WI, USA.
¹⁴ Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, MO, USA.
¹⁵ University Clinical Center of Serbia, University of Belgrade, Belgrade, Serbia.
¹⁶ Department of Internal Medicine I, University Hospital Aachen, RWTH Aachen University, Aachen, Germany.
¹⁷ American Heart Association, Dallas, TX, USA.
¹⁸ CGParkin Communications, Inc., Henderson, NV, USA.
¹⁹ Endocrine and Metabolic Consultants, Rockville, MD, USA.
²⁰ Sciarc GmbH, Baierbrunn, Germany.
²¹ Department of Medicine K2, Karolinska Institute, Stockholm, Sweden.
²² Institute of Molecular and Genomic Medicine, National Research Health Institutes, Zhunan, Miaoli, Taiwan.
²³ Forschergruppe Diabetes e. V, Helmholtz Center Munich, Ingolstaedter Landstraße 1, 85764, Neuherberg (Munich), Germany.
²⁴ Future Evidence Foundation, Melbourne, Australia.
²⁵ Department of Family Medicine, Acıbadem Mehmet Ali Aydınlar University School of Medicine, Istanbul, Turkey.
²⁶ Department of Medicine, Lovisenberg Diaconal Hospital, Institute of Health and Society, University of Oslo, Oslo, Norway.
²⁷ Department of Internal Medicine I, Universitätsklinikum Würzburg, Würzburg, Germany.
²⁸ Forschergruppe Diabetes e. V, Helmholtz Center Munich, Ingolstaedter Landstraße 1, 85764, Neuherberg (Munich), Germany. oliver.schnell@lrz.uni-muenchen.de.

PMID: 39920737
PMCID: PMC11806799
DOI: 10.1186/s12933-024-02550-2

Defining patient-reported outcomes in diabetes, obesity, cardiovascular disease, and chronic kidney disease for clinical practice guidelines - perspectives of the taskforce of the Guideline Workshop

Katharine Barnard-Kelly et al. Cardiovasc Diabetol. 2025.

. 2025 Feb 7;24(1):68.

doi: 10.1186/s12933-024-02550-2.

Authors

Affiliations

¹ Southern Health NHS Foundation Trust, Southampton, UK.
² Spotlight-AQ Ltd, Fareham, UK.
³ University Medical Center, Ljubljana, Slovenia.
⁴ Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
⁵ University of Arizona College of Medicine, Tucson, AZ, USA.
⁶ IRCCS MultiMedica, Via Milanese 300, Milan, Italy.
⁷ Cardiology Unit, Department of Medicine, Karolinska Institute, Karolinska University Hospital, Solna, Stockholm, Sweden.
⁸ Emory University School of Medicine, Atlanta, GA, USA.
⁹ Department of Precision and Regenerative Medicine and Ionian Area, Section of Internal Medicine, Endocrinology, Andrology and Metabolic Diseases, University of Bari Aldo Moro, Bari, Italy.
¹⁰ Duke University Medical Center, Duke Clinical Research Institute, Durham, NC, USA.
¹¹ Peking University People's Hospital, Beijing, China.
¹² Marienhospital Stuttgart, Stuttgart, Germany.
¹³ PCNA National Office, Madison, WI, USA.
¹⁴ Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, MO, USA.
¹⁵ University Clinical Center of Serbia, University of Belgrade, Belgrade, Serbia.
¹⁶ Department of Internal Medicine I, University Hospital Aachen, RWTH Aachen University, Aachen, Germany.
¹⁷ American Heart Association, Dallas, TX, USA.
¹⁸ CGParkin Communications, Inc., Henderson, NV, USA.
¹⁹ Endocrine and Metabolic Consultants, Rockville, MD, USA.
²⁰ Sciarc GmbH, Baierbrunn, Germany.
²¹ Department of Medicine K2, Karolinska Institute, Stockholm, Sweden.
²² Institute of Molecular and Genomic Medicine, National Research Health Institutes, Zhunan, Miaoli, Taiwan.
²³ Forschergruppe Diabetes e. V, Helmholtz Center Munich, Ingolstaedter Landstraße 1, 85764, Neuherberg (Munich), Germany.
²⁴ Future Evidence Foundation, Melbourne, Australia.
²⁵ Department of Family Medicine, Acıbadem Mehmet Ali Aydınlar University School of Medicine, Istanbul, Turkey.
²⁶ Department of Medicine, Lovisenberg Diaconal Hospital, Institute of Health and Society, University of Oslo, Oslo, Norway.
²⁷ Department of Internal Medicine I, Universitätsklinikum Würzburg, Würzburg, Germany.
²⁸ Forschergruppe Diabetes e. V, Helmholtz Center Munich, Ingolstaedter Landstraße 1, 85764, Neuherberg (Munich), Germany. oliver.schnell@lrz.uni-muenchen.de.

PMID: 39920737
PMCID: PMC11806799
DOI: 10.1186/s12933-024-02550-2

Abstract

Recent clinical practice guidelines for diabetes, obesity, cardiovascular disease (CVD) and chronic kidney disease (CKD) emphasise a holistic, person-centred approach to care. However, they do not include recommendations for the assessment of patient-reported outcomes (PROs), which would - dependent on the topic of guideline - be important for improving shared decision-making, patients' concordance with guideline recommendations, clinical outcomes and health-related quality of life (HRQoL). The Taskforce of the Guideline Workshop discussed PROs in diabetes, obesity, CVD and CKD as well as the relevance of their inclusion in clinical practice guidelines for the management of these conditions.

Keywords: Cardiovascular disease; Chronic kidney disease; Diabetes; Obesity; Person-reported outcomes.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: Not applicable. Consent for publication: Not applicable. Competing interests: Katharine Barnard-Kelly is founder and shareholder at Spotlight-AQ Ltd. KBK has received research support from Dexcom, Embecta, JDRF, Novo Nordisk and Roche Diabetes Care, and honoraria from Sanofi. Tadej Battelino has served on the advisory boards of Abbott, Boehringer Ingelheim, Dreamed Diabetes, Eli Lilly and Company, Indigo Diabetes, Medtronic, Novo Nordisk, and Sanofi. TB has received speaker’s bureau honoraria from Abbott, Eli Lilly and Company, Medtronic, Novo Nordisk, Roche, and Sanofi. The University Medical Center has received research grant support from Abbott, GluSense, Medtronic, Novo Nordisk, Sandoz, Sanofi, and Zealand Pharma. Frank C. Brosius is a consultant for MAKSCIENTIFIC. Antonio Ceriello reports consulting and speaking for Bayer, Berlin-Chemie, Eli Lilly and Company, Guidotti, Merck, Novo Nordisk, Roche Diagnostics and Sanofi. Francesco Cosentino has nothing reported. Julian Elliott has nothing reported. James R. Gavin III has served on the advisory boards of Abbott Diabetes Care and Embecta, and on the speaker’s bureaus of Boehringer Ingelheim and Eli Lilly and Company. Francesco Giorgino has served on the advisory boards of AstraZeneca, Eli Lilly and Company, Novo Nordisk, Roche Diabetes Care, Sanofi and as a consultant to AstraZeneca, Boehringer Ingelheim, LifeScan, Medimmune, Medtronic, Merck Sharp & Dohme, Roche Diabetes Care and Sanofi. FG has also received research support from Eli Lilly and Company and Roche Diabetes Care. Jennifer Green has nothing reported. Linong Ji declares that he has no competing interests. Monika Kellerer has served on advisory boards of Abbott Diabetes Care, Astra Zeneca, Bayer AG, Boehringer-Ingelheim, Eli Lilly, NovoNordisk and Sanofi. Sue Koob has nothing reported. Mikhail Kosiborod reports consulting or advisory board participation for 35Pharma, Alnylam Pharmaceuticals, Amgen, Applied Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Dexcom, Eli Lilly and Company, Esperion Therapeutics, Janssen Pharmaceuticals, Lexicon Pharmaceuticals, Merck (Diabetes and Cardiovascular), Novo Nordisk, Pharmacosmos, Pfizer, scPharmaceuticals, Sanofi, Structure Therapeutics, Vifor Pharma and Youngene Therapeutics. MK has also received honoraria from AstraZeneca, Boehringer Ingelheim and Novo Nordisk, and research grants from AstraZeneca, Boehringer Ingelheim and Pfizer. Nebojsa Lalic declares that he has no competing interests. Nikolaus Marx has received research grants from Boehringer Ingelheim and MSD, speaking fees form Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Eli Lilly and Company, MSD, Novo Nordisk, and Sanofi-Aventis and has served or serves on the advisory board of Amgen, Bayer, BMS, Boehringer Ingelheim, MSD, Novo Nordisk, and Sanofi-Aventis. Prashant Nedungadi has nothing reported. Christopher G. Parkin has nothing reported. Helena W. Rodbard declares that she has no competing interests. René D. Rötzer is employee of Sciarc GmbH. Lars Rydén declares that he has no competing interests related to this work. Wayne Sheu has nothing reported. Eberhard Standl declares that he has no competing interests. Britta Tendal Jeppesen declares that she has no competing interests. Pinar Topsever has received honoraria or consulting fees from AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, and LifeScan, and has served on the speaker’s bureau for AstraZeneca. PT received grant/research support from PCDE, made possible by corporate sponsorship from AstraZeneca, Eli Lilly, Novo Nordisk, and Roche Diagnostics; the sponsors had no input into the study protocols. Per Olav Vandvik has nothing reported. Christoph Wanner received honoraria for steering committee and adboard participation as well as lecturing from Alexion, AstraZeneca, Bayer, Boehringer Ingelheim, Eli-Lilly, MSD, Novo Nordisk and Sanofi. Oliver Schnell is founder and CEO at Sciarc GmbH, Baierbrunn, Germany.

Figures

**Fig. 1**
Recommendation from the 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure on the assessment of PROs [54, 56]. Abbreviations: C-LD, Level C-Limited Data; COR, Class of Recommendation; LOE, Level of Evidence

**Fig. 2**
The impact on clinical care of incorporating PRO assessment into the core components of future clinical practice guidelines for the management of diabetes, obesity, CVD and CKD

See this image and copyright information in PMC

References

1. Federation ID. IDF Diabetes Atlas. 10th ed. Belgium: Brussels; 2021.
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Defining patient-reported outcomes in diabetes, obesity, cardiovascular disease, and chronic kidney disease for clinical practice guidelines - perspectives of the taskforce of the Guideline Workshop

Affiliations

Defining patient-reported outcomes in diabetes, obesity, cardiovascular disease, and chronic kidney disease for clinical practice guidelines - perspectives of the taskforce of the Guideline Workshop

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

MeSH terms

LinkOut - more resources

Full Text Sources

Medical

Miscellaneous