Range and Consistency of Cardiovascular Outcomes Reported by Clinical Trials in Kidney Transplant Recipients: A Systematic Review
Background. Cardiovascular disease is a major cause of morbidity and mortality in kidney transplant recipients. Trial evidence to improve cardiovascular outcomes is limited by inconsistent reporting of outcomes, which may also lack patient-relevance. This study aimed to assess the range and consiste...
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| Format: | Article |
| Language: | English |
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Wolters Kluwer
2023-01-01
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| Series: | Transplantation Direct |
| Online Access: | http://journals.lww.com/transplantationdirect/fulltext/10.1097/TXD.0000000000001398 |
| _version_ | 1797947148417892352 |
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| author | Gregory J. Wilson, MBBS Kim Van, MBBS Emma O’Lone, PhD Allison Tong, PhD Jonathan C. Craig, PhD Benedicte Sautenet, PhD Klemens Budde, MD Derek Forfang John Gill, MD William G. Herrington, MD Tazeen H. Jafar, MPH David W. Johnson, PhD Vera Krane, MD Adeera Levin, MD Jolanta Malyszko, PhD Patrick Rossignol, PhD Deirdre Sawinski, MD Nicole Scholes-Robertons, PhD Giovanni Strippoli, PhD Angela Wang, PhD Wolfgang C. Winkelmayer, MD Carmel M. Hawley, MMedSci Andrea K. Viecelli, PhD |
| author_facet | Gregory J. Wilson, MBBS Kim Van, MBBS Emma O’Lone, PhD Allison Tong, PhD Jonathan C. Craig, PhD Benedicte Sautenet, PhD Klemens Budde, MD Derek Forfang John Gill, MD William G. Herrington, MD Tazeen H. Jafar, MPH David W. Johnson, PhD Vera Krane, MD Adeera Levin, MD Jolanta Malyszko, PhD Patrick Rossignol, PhD Deirdre Sawinski, MD Nicole Scholes-Robertons, PhD Giovanni Strippoli, PhD Angela Wang, PhD Wolfgang C. Winkelmayer, MD Carmel M. Hawley, MMedSci Andrea K. Viecelli, PhD |
| author_sort | Gregory J. Wilson, MBBS |
| collection | DOAJ |
| description | Background. Cardiovascular disease is a major cause of morbidity and mortality in kidney transplant recipients. Trial evidence to improve cardiovascular outcomes is limited by inconsistent reporting of outcomes, which may also lack patient-relevance. This study aimed to assess the range and consistency of cardiovascular outcomes reported by contemporary trials in kidney transplant recipients.
Methods. A systematic review of all randomized controlled trials involving adult kidney transplant recipients that reported at least 1 cardiovascular outcome from January 2012 to December 2019 was performed, including Embase, MEDLINE, Cochrane, and ClinicalTrials.gov electronic databases. Trial characteristics were extracted and all levels of specification of the cardiovascular outcome measures reported were analyzed (the measure definition, metric‚ and method of aggregation). Measures assessing a similar aspect of cardiovascular disease were categorized into outcomes.
Results. From 93 eligible trials involving 27 609 participants, 490 outcome measures were identified. The outcome measures were grouped into 38 outcomes. A cardiovascular composite was the most common outcome reported (40 trials, 43%) followed by cardiovascular mortality (42%) and acute coronary syndrome (31%). Cardiovascular composite was also the most heterogeneous outcome with 77 measures reported followed by cardiovascular mortality (n = 58) and inflammatory biomarkers (n = 51). The most common cardiovascular composite outcome components reported were major cardiovascular events (18 trials), stroke unspecified (11 trials), and myocardial infarction unspecified (10 trials).
Conclusions. There is substantial heterogeneity in cardiovascular outcome reporting in kidney transplant trials. |
| first_indexed | 2024-04-10T21:22:14Z |
| format | Article |
| id | doaj.art-dafa5e127e2741c1bbcc88a9fe7226fd |
| institution | Directory Open Access Journal |
| issn | 2373-8731 |
| language | English |
| last_indexed | 2024-04-10T21:22:14Z |
| publishDate | 2023-01-01 |
| publisher | Wolters Kluwer |
| record_format | Article |
| series | Transplantation Direct |
| spelling | doaj.art-dafa5e127e2741c1bbcc88a9fe7226fd2023-01-20T02:41:41ZengWolters KluwerTransplantation Direct2373-87312023-01-0191e139810.1097/TXD.0000000000001398202301000-00001Range and Consistency of Cardiovascular Outcomes Reported by Clinical Trials in Kidney Transplant Recipients: A Systematic ReviewGregory J. Wilson, MBBS0Kim Van, MBBS1Emma O’Lone, PhD2Allison Tong, PhD3Jonathan C. Craig, PhD4Benedicte Sautenet, PhD5Klemens Budde, MD6Derek Forfang7John Gill, MD8William G. Herrington, MD9Tazeen H. Jafar, MPH10David W. Johnson, PhD11Vera Krane, MD12Adeera Levin, MD13Jolanta Malyszko, PhD14Patrick Rossignol, PhD15Deirdre Sawinski, MD16Nicole Scholes-Robertons, PhD17Giovanni Strippoli, PhD18Angela Wang, PhD19Wolfgang C. Winkelmayer, MD20Carmel M. Hawley, MMedSci21Andrea K. Viecelli, PhD221 Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia.4 Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.4 Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.4 Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.5 College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.6 Service de Nephrologie-Hypertension, Dialyses, Transplantation Rénale, Hopital Bretonneau, Université de Tours, Université de Nantes, INSERM SPHERE U 1246, Tours, France.7 Charité Universitätsmedizin Berlin, Berlin, Germany.8 National Kidney Foundation, New York, NY.9 University of British Columbia, Vancouver, BC, Canada.10 Nuffield Department of Population Health, Medical Research Council Population Health Research Unit at the University of Oxford, Oxford, United Kingdom.11 Duke – NUS Medical School, Singapore, Singapore.1 Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia.12 University of Würzburg, Würzburg, Germany.13 University of British Columbia, Vancouver, BC, Canada.14 Department of Medicine, Division of Nephrology, University of Wurzburg, Wurzburg, Germany.15 Université de Lorraine & FCRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists) Network, Nancy, France.16 Weill Cornell Medical College, New York, NY.17 The University of Sydney, Sydney, NSW, Australia.18 University of Bari, Bari, Italy.19 The University of Hong Kong, Pok Fu Lam, Hong Kong.20 Baylor College of Medicine, Houston, TX.1 Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia.1 Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia.Background. Cardiovascular disease is a major cause of morbidity and mortality in kidney transplant recipients. Trial evidence to improve cardiovascular outcomes is limited by inconsistent reporting of outcomes, which may also lack patient-relevance. This study aimed to assess the range and consistency of cardiovascular outcomes reported by contemporary trials in kidney transplant recipients. Methods. A systematic review of all randomized controlled trials involving adult kidney transplant recipients that reported at least 1 cardiovascular outcome from January 2012 to December 2019 was performed, including Embase, MEDLINE, Cochrane, and ClinicalTrials.gov electronic databases. Trial characteristics were extracted and all levels of specification of the cardiovascular outcome measures reported were analyzed (the measure definition, metric‚ and method of aggregation). Measures assessing a similar aspect of cardiovascular disease were categorized into outcomes. Results. From 93 eligible trials involving 27 609 participants, 490 outcome measures were identified. The outcome measures were grouped into 38 outcomes. A cardiovascular composite was the most common outcome reported (40 trials, 43%) followed by cardiovascular mortality (42%) and acute coronary syndrome (31%). Cardiovascular composite was also the most heterogeneous outcome with 77 measures reported followed by cardiovascular mortality (n = 58) and inflammatory biomarkers (n = 51). The most common cardiovascular composite outcome components reported were major cardiovascular events (18 trials), stroke unspecified (11 trials), and myocardial infarction unspecified (10 trials). Conclusions. There is substantial heterogeneity in cardiovascular outcome reporting in kidney transplant trials.http://journals.lww.com/transplantationdirect/fulltext/10.1097/TXD.0000000000001398 |
| spellingShingle | Gregory J. Wilson, MBBS Kim Van, MBBS Emma O’Lone, PhD Allison Tong, PhD Jonathan C. Craig, PhD Benedicte Sautenet, PhD Klemens Budde, MD Derek Forfang John Gill, MD William G. Herrington, MD Tazeen H. Jafar, MPH David W. Johnson, PhD Vera Krane, MD Adeera Levin, MD Jolanta Malyszko, PhD Patrick Rossignol, PhD Deirdre Sawinski, MD Nicole Scholes-Robertons, PhD Giovanni Strippoli, PhD Angela Wang, PhD Wolfgang C. Winkelmayer, MD Carmel M. Hawley, MMedSci Andrea K. Viecelli, PhD Range and Consistency of Cardiovascular Outcomes Reported by Clinical Trials in Kidney Transplant Recipients: A Systematic Review Transplantation Direct |
| title | Range and Consistency of Cardiovascular Outcomes Reported by Clinical Trials in Kidney Transplant Recipients: A Systematic Review |
| title_full | Range and Consistency of Cardiovascular Outcomes Reported by Clinical Trials in Kidney Transplant Recipients: A Systematic Review |
| title_fullStr | Range and Consistency of Cardiovascular Outcomes Reported by Clinical Trials in Kidney Transplant Recipients: A Systematic Review |
| title_full_unstemmed | Range and Consistency of Cardiovascular Outcomes Reported by Clinical Trials in Kidney Transplant Recipients: A Systematic Review |
| title_short | Range and Consistency of Cardiovascular Outcomes Reported by Clinical Trials in Kidney Transplant Recipients: A Systematic Review |
| title_sort | range and consistency of cardiovascular outcomes reported by clinical trials in kidney transplant recipients a systematic review |
| url | http://journals.lww.com/transplantationdirect/fulltext/10.1097/TXD.0000000000001398 |
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