The win ratio approach to analyzing composite outcomes: An application to the EVOLVE trial
Unlike conventional time-to-event analysis of composite endpoints in clinical trials, the “win ratio” method allows for flexibility in prioritizing their components. Here, we compare the EVOLVE trial findings using the win ratio with those from time-to-event analysis. Exposure: Randomization to cina...
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| Published in: | Contemporary clinical trials Vol. 48; pp. 119 - 124 |
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01.05.2016
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| Abstract | Unlike conventional time-to-event analysis of composite endpoints in clinical trials, the “win ratio” method allows for flexibility in prioritizing their components. Here, we compare the EVOLVE trial findings using the win ratio with those from time-to-event analysis.
Exposure: Randomization to cinacalcet or placebo.
Outcome: The primary composite endpoint combining all-cause mortality and non-fatal myocardial infarction, hospitalization for unstable angina, heart failure, and peripheral vascular events.
Analysis: In an unadjusted analysis, we paired each participant from the cinacalcet arm with every participant from the placebo arm within randomization strata. Pairs were classified as “winners” or “losers,” according to which participant died first during the shared follow-up time, or experienced the next ranked event first. We ranked non-fatal events in two ways: 1) all ranked evenly; and 2) prioritized by their effect on health-related quality of life. The win ratio equaled the total winners divided by total losers. Further analyses were conducted where the win ratio was stratified by, or adjusted for, age.
The unadjusted win ratio for the primary composite endpoint was 1.09 (95% CI 0.97 to 1.21), a statistically non-significant result which supports the primary trial result — unadjusted hazard ratio 0.93 (95% CI 0.85 to 1.02). Age-stratified analyses showed a nominally significant benefit of cinacalcet (win ratio 1.14, 95% CI 1.04 to 1.26). Ranking of non-fatal outcomes by their relative effects on quality of life did not materially alter the results.
The win ratio method corroborated the findings of EVOLVE based on conventional time-to-event analysis.
EVOLVE ClinicalTrials.gov number: NCT00345839. |
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| AbstractList | Unlike conventional time-to-event analysis of composite endpoints in clinical trials, the “win ratio” method allows for flexibility in prioritizing their components. Here, we compare the EVOLVE trial findings using the win ratio with those from time-to-event analysis.
Exposure: Randomization to cinacalcet or placebo.
Outcome: The primary composite endpoint combining all-cause mortality and non-fatal myocardial infarction, hospitalization for unstable angina, heart failure, and peripheral vascular events.
Analysis: In an unadjusted analysis, we paired each participant from the cinacalcet arm with every participant from the placebo arm within randomization strata. Pairs were classified as “winners” or “losers,” according to which participant died first during the shared follow-up time, or experienced the next ranked event first. We ranked non-fatal events in two ways: 1) all ranked evenly; and 2) prioritized by their effect on health-related quality of life. The win ratio equaled the total winners divided by total losers. Further analyses were conducted where the win ratio was stratified by, or adjusted for, age.
The unadjusted win ratio for the primary composite endpoint was 1.09 (95% CI 0.97 to 1.21), a statistically non-significant result which supports the primary trial result — unadjusted hazard ratio 0.93 (95% CI 0.85 to 1.02). Age-stratified analyses showed a nominally significant benefit of cinacalcet (win ratio 1.14, 95% CI 1.04 to 1.26). Ranking of non-fatal outcomes by their relative effects on quality of life did not materially alter the results.
The win ratio method corroborated the findings of EVOLVE based on conventional time-to-event analysis.
EVOLVE ClinicalTrials.gov number: NCT00345839. Unlike conventional time-to-event analysis of composite endpoints in clinical trials, the "win ratio" method allows for flexibility in prioritizing their components. Here, we compare the EVOLVE trial findings using the win ratio with those from time-to-event analysis. Randomization to cinacalcet or placebo. The primary composite endpoint combining all-cause mortality and non-fatal myocardial infarction, hospitalization for unstable angina, heart failure, and peripheral vascular events. In an unadjusted analysis, we paired each participant from the cinacalcet arm with every participant from the placebo arm within randomization strata. Pairs were classified as "winners" or "losers," according to which participant died first during the shared follow-up time, or experienced the next ranked event first. We ranked non-fatal events in two ways: 1) all ranked evenly; and 2) prioritized by their effect on health-related quality of life. The win ratio equaled the total winners divided by total losers. Further analyses were conducted where the win ratio was stratified by, or adjusted for, age. The unadjusted win ratio for the primary composite endpoint was 1.09 (95% CI 0.97 to 1.21), a statistically non-significant result which supports the primary trial result - unadjusted hazard ratio 0.93 (95% CI 0.85 to 1.02). Age-stratified analyses showed a nominally significant benefit of cinacalcet (win ratio 1.14, 95% CI 1.04 to 1.26). Ranking of non-fatal outcomes by their relative effects on quality of life did not materially alter the results. The win ratio method corroborated the findings of EVOLVE based on conventional time-to-event analysis. EVOLVE ClinicalTrials.gov number: NCT00345839. Abstract Background Unlike conventional time-to-event analysis of composite endpoints in clinical trials, the “win ratio” method allows for flexibility in prioritizing their components. Here, we compare the EVOLVE trial findings using the win ratio with those from time-to-event analysis. Methods Exposure : Randomization to cinacalcet or placebo. Outcome : The primary composite endpoint combining all-cause mortality and non-fatal myocardial infarction, hospitalization for unstable angina, heart failure, and peripheral vascular events. Analysis : In an unadjusted analysis, we paired each participant from the cinacalcet arm with every participant from the placebo arm within randomization strata. Pairs were classified as “winners” or “losers,” according to which participant died first during the shared follow-up time, or experienced the next ranked event first. We ranked non-fatal events in two ways: 1) all ranked evenly; and 2) prioritized by their effect on health-related quality of life. The win ratio equaled the total winners divided by total losers. Further analyses were conducted where the win ratio was stratified by, or adjusted for, age. Results The unadjusted win ratio for the primary composite endpoint was 1.09 (95% CI 0.97 to 1.21), a statistically non-significant result which supports the primary trial result — unadjusted hazard ratio 0.93 (95% CI 0.85 to 1.02). Age-stratified analyses showed a nominally significant benefit of cinacalcet (win ratio 1.14, 95% CI 1.04 to 1.26). Ranking of non-fatal outcomes by their relative effects on quality of life did not materially alter the results. Conclusion The win ratio method corroborated the findings of EVOLVE based on conventional time-to-event analysis. EVOLVE ClinicalTrials.gov number: NCT00345839. Unlike conventional time-to-event analysis of composite endpoints in clinical trials, the "win ratio" method allows for flexibility in prioritizing their components. Here, we compare the EVOLVE trial findings using the win ratio with those from time-to-event analysis.BACKGROUNDUnlike conventional time-to-event analysis of composite endpoints in clinical trials, the "win ratio" method allows for flexibility in prioritizing their components. Here, we compare the EVOLVE trial findings using the win ratio with those from time-to-event analysis.Randomization to cinacalcet or placebo.EXPOSURERandomization to cinacalcet or placebo.The primary composite endpoint combining all-cause mortality and non-fatal myocardial infarction, hospitalization for unstable angina, heart failure, and peripheral vascular events.OUTCOMEThe primary composite endpoint combining all-cause mortality and non-fatal myocardial infarction, hospitalization for unstable angina, heart failure, and peripheral vascular events.In an unadjusted analysis, we paired each participant from the cinacalcet arm with every participant from the placebo arm within randomization strata. Pairs were classified as "winners" or "losers," according to which participant died first during the shared follow-up time, or experienced the next ranked event first. We ranked non-fatal events in two ways: 1) all ranked evenly; and 2) prioritized by their effect on health-related quality of life. The win ratio equaled the total winners divided by total losers. Further analyses were conducted where the win ratio was stratified by, or adjusted for, age.ANALYSISIn an unadjusted analysis, we paired each participant from the cinacalcet arm with every participant from the placebo arm within randomization strata. Pairs were classified as "winners" or "losers," according to which participant died first during the shared follow-up time, or experienced the next ranked event first. We ranked non-fatal events in two ways: 1) all ranked evenly; and 2) prioritized by their effect on health-related quality of life. The win ratio equaled the total winners divided by total losers. Further analyses were conducted where the win ratio was stratified by, or adjusted for, age.The unadjusted win ratio for the primary composite endpoint was 1.09 (95% CI 0.97 to 1.21), a statistically non-significant result which supports the primary trial result - unadjusted hazard ratio 0.93 (95% CI 0.85 to 1.02). Age-stratified analyses showed a nominally significant benefit of cinacalcet (win ratio 1.14, 95% CI 1.04 to 1.26). Ranking of non-fatal outcomes by their relative effects on quality of life did not materially alter the results.RESULTSThe unadjusted win ratio for the primary composite endpoint was 1.09 (95% CI 0.97 to 1.21), a statistically non-significant result which supports the primary trial result - unadjusted hazard ratio 0.93 (95% CI 0.85 to 1.02). Age-stratified analyses showed a nominally significant benefit of cinacalcet (win ratio 1.14, 95% CI 1.04 to 1.26). Ranking of non-fatal outcomes by their relative effects on quality of life did not materially alter the results.The win ratio method corroborated the findings of EVOLVE based on conventional time-to-event analysis. EVOLVE ClinicalTrials.gov number: NCT00345839.CONCLUSIONThe win ratio method corroborated the findings of EVOLVE based on conventional time-to-event analysis. EVOLVE ClinicalTrials.gov number: NCT00345839. |
| Author | Abdalla, Safa Parfrey, Patrick S. Montez-Rath, Maria E. Chertow, Glenn M. |
| Author_xml | – sequence: 1 givenname: Safa surname: Abdalla fullname: Abdalla, Safa email: sabdalla@stanford.edu, safa.abdalla@gmail.com organization: Stanford University School of Medicine, Palo Alto, CA, USA – sequence: 2 givenname: Maria E. surname: Montez-Rath fullname: Montez-Rath, Maria E. organization: Stanford University School of Medicine, Palo Alto, CA, USA – sequence: 3 givenname: Patrick S. surname: Parfrey fullname: Parfrey, Patrick S. organization: Health Sciences Center St. John's, Newfoundland, Canada – sequence: 4 givenname: Glenn M. surname: Chertow fullname: Chertow, Glenn M. organization: Stanford University School of Medicine, Palo Alto, CA, USA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/27080930$$D View this record in MEDLINE/PubMed |
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| Snippet | Unlike conventional time-to-event analysis of composite endpoints in clinical trials, the “win ratio” method allows for flexibility in prioritizing their... Abstract Background Unlike conventional time-to-event analysis of composite endpoints in clinical trials, the “win ratio” method allows for flexibility in... Unlike conventional time-to-event analysis of composite endpoints in clinical trials, the "win ratio" method allows for flexibility in prioritizing their... |
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| SubjectTerms | Aged Angina, Unstable - epidemiology Calcimimetic Agents - therapeutic use Cardiovascular Cause of Death Cinacalcet Cinacalcet Hydrochloride - therapeutic use Composite endpoints EVOLVE trial Female Heart Failure - epidemiology Hematology, Oncology and Palliative Medicine Hospitalization - statistics & numerical data Humans Kidney Failure, Chronic - drug therapy Male Middle Aged Mortality Myocardial Infarction - epidemiology Peripheral Vascular Diseases - epidemiology Proportional Hazards Models Randomized Controlled Trials as Topic Treatment Outcome Win ratio |
| Title | The win ratio approach to analyzing composite outcomes: An application to the EVOLVE trial |
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