Multidisciplinary stakeholder engagement in a type 2 diabetes comparative effectiveness study utilizing real-world data
Abstract Introduction: Patient and stakeholder involvement enhances the conduct and applicability of comparative effectiveness research (CER). However, examples of engagement practices for CER leveraging real-world data (i.e., data from routine clinical practice) are scarce. Notably, these studies...
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Cambridge University Press
2024-01-01
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| Series: | Journal of Clinical and Translational Science |
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| Online Access: | https://www.cambridge.org/core/product/identifier/S2059866124006666/type/journal_article |
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| author | Elizabeth H. Golembiewski Mindy M. Mickelson Juan P. Brito Victor M. Montori Rozalina G. McCoy |
| author_facet | Elizabeth H. Golembiewski Mindy M. Mickelson Juan P. Brito Victor M. Montori Rozalina G. McCoy |
| author_sort | Elizabeth H. Golembiewski |
| collection | DOAJ |
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Abstract
Introduction:
Patient and stakeholder involvement enhances the conduct and applicability of comparative effectiveness research (CER). However, examples of engagement practices for CER leveraging real-world data (i.e., data from routine clinical practice) are scarce. Notably, these studies differ from traditional clinical trials in their technical complexity and minimal prospective data collection, posing unique challenges for stakeholder involvement. This paper describes patient and stakeholder engagement in a CER study of type 2 diabetes (T2D) medications using real-world data from a large administrative claims database.
Methods:
A Patient and Stakeholder Advisory Group (PSAG) was formed to guide study design, conduct, and dissemination. The PSAG (n = 12) included individuals with T2D, clinicians, health systems leaders, professional society representatives, and a payer representative. Members were surveyed post-study initiation to assess their participation goals and experiences to date.
Results:
PSAG members influenced key design and methodological decisions, including cohort selection and adding an aim focused on patient preference elicitation. Survey results indicated high satisfaction with engagement processes and a desire for ongoing involvement. Most PSAG members cited their main goals as impacting the lives of people with T2D and ensuring the research’s relevance to clinicians.
Conclusions:
Best practices for engaging stakeholders in CER using real-world data are underdeveloped. Our experience suggests that an inclusive, stakeholder-engaged approach enriches the research process and ensures diverse perspectives are integrated into study design and conduct. Ongoing efforts will focus on assessing long-term engagement outcomes and PSAG member satisfaction.
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| format | Article |
| id | doaj-art-8503b05a8d0d424dbdbeef9c47a48455 |
| institution | Kabale University |
| issn | 2059-8661 |
| language | English |
| publishDate | 2024-01-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj-art-8503b05a8d0d424dbdbeef9c47a484552025-01-16T21:50:01ZengCambridge University PressJournal of Clinical and Translational Science2059-86612024-01-01810.1017/cts.2024.666Multidisciplinary stakeholder engagement in a type 2 diabetes comparative effectiveness study utilizing real-world dataElizabeth H. Golembiewski0https://orcid.org/0000-0003-1015-3935Mindy M. Mickelson1Juan P. Brito2Victor M. Montori3Rozalina G. McCoy4Knowledge and Evaluation Research (KER) Unit, Mayo Clinic, Rochester, MN, USA Division of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USARobert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USAKnowledge and Evaluation Research (KER) Unit, Mayo Clinic, Rochester, MN, USA Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, MN, USAKnowledge and Evaluation Research (KER) Unit, Mayo Clinic, Rochester, MN, USA Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, MN, USADepartment of Medicine, Division of Endocrinology, Diabetes and Nutrition, University of Maryland School of Medicine, Baltimore, MD, USA University of Maryland Institute for Health Computing, North Bethesda, MD, USA Department of Health Policy and Management, University of Maryland School of Public Health, College Park, MD, USA Abstract Introduction: Patient and stakeholder involvement enhances the conduct and applicability of comparative effectiveness research (CER). However, examples of engagement practices for CER leveraging real-world data (i.e., data from routine clinical practice) are scarce. Notably, these studies differ from traditional clinical trials in their technical complexity and minimal prospective data collection, posing unique challenges for stakeholder involvement. This paper describes patient and stakeholder engagement in a CER study of type 2 diabetes (T2D) medications using real-world data from a large administrative claims database. Methods: A Patient and Stakeholder Advisory Group (PSAG) was formed to guide study design, conduct, and dissemination. The PSAG (n = 12) included individuals with T2D, clinicians, health systems leaders, professional society representatives, and a payer representative. Members were surveyed post-study initiation to assess their participation goals and experiences to date. Results: PSAG members influenced key design and methodological decisions, including cohort selection and adding an aim focused on patient preference elicitation. Survey results indicated high satisfaction with engagement processes and a desire for ongoing involvement. Most PSAG members cited their main goals as impacting the lives of people with T2D and ensuring the research’s relevance to clinicians. Conclusions: Best practices for engaging stakeholders in CER using real-world data are underdeveloped. Our experience suggests that an inclusive, stakeholder-engaged approach enriches the research process and ensures diverse perspectives are integrated into study design and conduct. Ongoing efforts will focus on assessing long-term engagement outcomes and PSAG member satisfaction. https://www.cambridge.org/core/product/identifier/S2059866124006666/type/journal_articlePatient and stakeholder engagementtype 2 diabetescomparative effectiveness researchreal-world datapatient-centered outcomes |
| spellingShingle | Elizabeth H. Golembiewski Mindy M. Mickelson Juan P. Brito Victor M. Montori Rozalina G. McCoy Multidisciplinary stakeholder engagement in a type 2 diabetes comparative effectiveness study utilizing real-world data Journal of Clinical and Translational Science Patient and stakeholder engagement type 2 diabetes comparative effectiveness research real-world data patient-centered outcomes |
| title | Multidisciplinary stakeholder engagement in a type 2 diabetes comparative effectiveness study utilizing real-world data |
| title_full | Multidisciplinary stakeholder engagement in a type 2 diabetes comparative effectiveness study utilizing real-world data |
| title_fullStr | Multidisciplinary stakeholder engagement in a type 2 diabetes comparative effectiveness study utilizing real-world data |
| title_full_unstemmed | Multidisciplinary stakeholder engagement in a type 2 diabetes comparative effectiveness study utilizing real-world data |
| title_short | Multidisciplinary stakeholder engagement in a type 2 diabetes comparative effectiveness study utilizing real-world data |
| title_sort | multidisciplinary stakeholder engagement in a type 2 diabetes comparative effectiveness study utilizing real world data |
| topic | Patient and stakeholder engagement type 2 diabetes comparative effectiveness research real-world data patient-centered outcomes |
| url | https://www.cambridge.org/core/product/identifier/S2059866124006666/type/journal_article |
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