Expanding the use and interpretation of patient-centric cardiovascular clinical trial endpoints
Significant improvements have been achieved to enhance the patient-centricity of clinical research, including the development and utilization of novel clinical trial endpoints. These include endpoints that harness outcomes that are important to patients and reflect the patients’ lived experiences. T...
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2025-01-01
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| Series: | Journal of Clinical and Translational Science |
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| Online Access: | https://www.cambridge.org/core/product/identifier/S205986612510054X/type/journal_article |
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| author | Shelby D. Reed Pishoy Gouda |
| author_facet | Shelby D. Reed Pishoy Gouda |
| author_sort | Shelby D. Reed |
| collection | DOAJ |
| description | Significant improvements have been achieved to enhance the patient-centricity of clinical research, including the development and utilization of novel clinical trial endpoints. These include endpoints that harness outcomes that are important to patients and reflect the patients’ lived experiences. This may take the form of utilizing variables such as days alive and out of hospital (DAOH) and quality-of-life adjusted outcomes. The use of composite outcomes can be used to enrich patient-centricity by weighting or ranking events. These approaches have several nuances that should be considered including selecting appropriate events, defining outcomes, how to elicit or construct weights, and whose opinions to consider. After weights have been determined, a variety of approaches exist to combine weights with outcomes and make comparisons between groups. The approaches, including the win ratio, weighted win ratio, desirability of outcome ranking (DOOR), multicriteria decision analysis (MCDA), and variations of time-to-first composite event analyses, have unique advantages and challenges depending on the clinical scenario. While improving patient-centric outcomes is of high importance to multiple stakeholders, more comparative work is needed to characterize the implications of alternative approaches. |
| format | Article |
| id | doaj-art-2ee2ee30d76a4a66bfc736709a43d032 |
| institution | Matheson Library |
| issn | 2059-8661 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj-art-2ee2ee30d76a4a66bfc736709a43d0322025-07-30T05:06:54ZengCambridge University PressJournal of Clinical and Translational Science2059-86612025-01-01910.1017/cts.2025.10054Expanding the use and interpretation of patient-centric cardiovascular clinical trial endpointsShelby D. Reed0https://orcid.org/0000-0002-7654-4464Pishoy Gouda1Duke Clinical Research Institute, Duke University, Durham, NC, USADuke Clinical Research Institute, Duke University, Durham, NC, USA University of Alberta, Edmonton, Alberta, CanadaSignificant improvements have been achieved to enhance the patient-centricity of clinical research, including the development and utilization of novel clinical trial endpoints. These include endpoints that harness outcomes that are important to patients and reflect the patients’ lived experiences. This may take the form of utilizing variables such as days alive and out of hospital (DAOH) and quality-of-life adjusted outcomes. The use of composite outcomes can be used to enrich patient-centricity by weighting or ranking events. These approaches have several nuances that should be considered including selecting appropriate events, defining outcomes, how to elicit or construct weights, and whose opinions to consider. After weights have been determined, a variety of approaches exist to combine weights with outcomes and make comparisons between groups. The approaches, including the win ratio, weighted win ratio, desirability of outcome ranking (DOOR), multicriteria decision analysis (MCDA), and variations of time-to-first composite event analyses, have unique advantages and challenges depending on the clinical scenario. While improving patient-centric outcomes is of high importance to multiple stakeholders, more comparative work is needed to characterize the implications of alternative approaches.https://www.cambridge.org/core/product/identifier/S205986612510054X/type/journal_articlePatient-centered outcomespatient-centric outcomesweighted endpointsclinical trialspatient preferencesnet benefit |
| spellingShingle | Shelby D. Reed Pishoy Gouda Expanding the use and interpretation of patient-centric cardiovascular clinical trial endpoints Journal of Clinical and Translational Science Patient-centered outcomes patient-centric outcomes weighted endpoints clinical trials patient preferences net benefit |
| title | Expanding the use and interpretation of patient-centric cardiovascular clinical trial endpoints |
| title_full | Expanding the use and interpretation of patient-centric cardiovascular clinical trial endpoints |
| title_fullStr | Expanding the use and interpretation of patient-centric cardiovascular clinical trial endpoints |
| title_full_unstemmed | Expanding the use and interpretation of patient-centric cardiovascular clinical trial endpoints |
| title_short | Expanding the use and interpretation of patient-centric cardiovascular clinical trial endpoints |
| title_sort | expanding the use and interpretation of patient centric cardiovascular clinical trial endpoints |
| topic | Patient-centered outcomes patient-centric outcomes weighted endpoints clinical trials patient preferences net benefit |
| url | https://www.cambridge.org/core/product/identifier/S205986612510054X/type/journal_article |
| work_keys_str_mv | AT shelbydreed expandingtheuseandinterpretationofpatientcentriccardiovascularclinicaltrialendpoints AT pishoygouda expandingtheuseandinterpretationofpatientcentriccardiovascularclinicaltrialendpoints |