Optimising the analysis of vascular prevention trials: Re-Assessment of the TARDIS trial, the first prevention trial to adopt an ordinal primary outcome measure
Background: Ordinalised vascular outcomes incorporating event severity are more informative than binary outcomes that just include event numbers. The TARDIS trial was the first vascular prevention study to use an ordinalised vascular outcome as its primary efficacy and safety measures and collected...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2023-10-01
|
| Series: | Contemporary Clinical Trials Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865423001321 |
| _version_ | 1797686773938126848 |
|---|---|
| author | Lisa J. Woodhouse Alan A. Montgomery Stuart Pocock Marilyn James Anna Ranta Philip M. Bath |
| author_facet | Lisa J. Woodhouse Alan A. Montgomery Stuart Pocock Marilyn James Anna Ranta Philip M. Bath |
| author_sort | Lisa J. Woodhouse |
| collection | DOAJ |
| description | Background: Ordinalised vascular outcomes incorporating event severity are more informative than binary outcomes that just include event numbers. The TARDIS trial was the first vascular prevention study to use an ordinalised vascular outcome as its primary efficacy and safety measures and collected severity information for other vascular events. Methods: TARDIS was an international prospective randomised open-label blinded-endpoint trial assessing one month of intensive versus guideline antiplatelet therapy in patients with acute non-cardioembolic stroke or TIA. Vascular events and their severity were recorded up to final follow-up at 90 days post randomisation. For each outcome, statistical techniques compared ordinal/continuous (10 models) and dichotomous (5 models) analyses; results were then ranked with the smallest p-value being given the smallest rank. Outcomes were also assessed within the pre-defined subgroup of participants with mild stroke (NIHSS≤3), or TIA recruited within 24 h. Results: Ordinal versions of vascular event outcomes were created in 3096 participants for stroke, myocardial infarction, major cardiac events, bleeding events, serious adverse events and venous thromboembolism (VTE), with 32 outcomes being created overall (29 in the subgroup population due to the absence of VTE events). Overall, the tests run on ordinal outcomes tended to rank higher than tests performed on binary outcomes. 764 (24.7%) participants were recruited within 24 h of a mild stroke/TIA; again, tests run on ordinal outcomes ranked higher. Conclusions: In TARDIS, tests performed on ordinal vascular outcomes tended to attain a higher rank than those performed on binary outcomes. Trial registration: ISRCTN47823388 |
| first_indexed | 2024-03-12T01:09:40Z |
| format | Article |
| id | doaj.art-4255cfd1edc54920a566d90a804fc8e6 |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-03-12T01:09:40Z |
| publishDate | 2023-10-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-4255cfd1edc54920a566d90a804fc8e62023-09-14T04:54:32ZengElsevierContemporary Clinical Trials Communications2451-86542023-10-0135101186Optimising the analysis of vascular prevention trials: Re-Assessment of the TARDIS trial, the first prevention trial to adopt an ordinal primary outcome measureLisa J. Woodhouse0Alan A. Montgomery1Stuart Pocock2Marilyn James3Anna Ranta4Philip M. Bath5Stroke Trials Unit, Mental Health & Clinical Neurosciences, School of Medicine, University of Nottingham, D Floor South Block, Queen's Medical Centre, Nottingham, NG7 2UH, UKNottingham Clinical Trials Unit, University of Nottingham, Queen's Medical Centre, Derby Road, Nottingham, NG7 2UH, UKLondon School of Hygiene & Tropical Medicine, Keppel St., London, WC1E 7HT, UKNottingham Clinical Trials Unit, University of Nottingham, Queen's Medical Centre, Derby Road, Nottingham, NG7 2UH, UKDepartment of Medicine, University of Otago Wellington, Wellington, 6242, New ZealandStroke Trials Unit, Mental Health & Clinical Neurosciences, School of Medicine, University of Nottingham, D Floor South Block, Queen's Medical Centre, Nottingham, NG7 2UH, UK; Stroke, Nottingham University Hospitals NHS Trust, Queen's Medical Centre, Nottingham, NG7 2UH, UK; Corresponding author. Stroke Trials Unit, Mental Health & Clinical Neurosciences, School of Medicine, Queen's Medical Centre, University of Nottingham, Nottingham, NG7 2UH, UK.Background: Ordinalised vascular outcomes incorporating event severity are more informative than binary outcomes that just include event numbers. The TARDIS trial was the first vascular prevention study to use an ordinalised vascular outcome as its primary efficacy and safety measures and collected severity information for other vascular events. Methods: TARDIS was an international prospective randomised open-label blinded-endpoint trial assessing one month of intensive versus guideline antiplatelet therapy in patients with acute non-cardioembolic stroke or TIA. Vascular events and their severity were recorded up to final follow-up at 90 days post randomisation. For each outcome, statistical techniques compared ordinal/continuous (10 models) and dichotomous (5 models) analyses; results were then ranked with the smallest p-value being given the smallest rank. Outcomes were also assessed within the pre-defined subgroup of participants with mild stroke (NIHSS≤3), or TIA recruited within 24 h. Results: Ordinal versions of vascular event outcomes were created in 3096 participants for stroke, myocardial infarction, major cardiac events, bleeding events, serious adverse events and venous thromboembolism (VTE), with 32 outcomes being created overall (29 in the subgroup population due to the absence of VTE events). Overall, the tests run on ordinal outcomes tended to rank higher than tests performed on binary outcomes. 764 (24.7%) participants were recruited within 24 h of a mild stroke/TIA; again, tests run on ordinal outcomes ranked higher. Conclusions: In TARDIS, tests performed on ordinal vascular outcomes tended to attain a higher rank than those performed on binary outcomes. Trial registration: ISRCTN47823388http://www.sciencedirect.com/science/article/pii/S2451865423001321TARDISStrokeSeverityOutcomeTime |
| spellingShingle | Lisa J. Woodhouse Alan A. Montgomery Stuart Pocock Marilyn James Anna Ranta Philip M. Bath Optimising the analysis of vascular prevention trials: Re-Assessment of the TARDIS trial, the first prevention trial to adopt an ordinal primary outcome measure Contemporary Clinical Trials Communications TARDIS Stroke Severity Outcome Time |
| title | Optimising the analysis of vascular prevention trials: Re-Assessment of the TARDIS trial, the first prevention trial to adopt an ordinal primary outcome measure |
| title_full | Optimising the analysis of vascular prevention trials: Re-Assessment of the TARDIS trial, the first prevention trial to adopt an ordinal primary outcome measure |
| title_fullStr | Optimising the analysis of vascular prevention trials: Re-Assessment of the TARDIS trial, the first prevention trial to adopt an ordinal primary outcome measure |
| title_full_unstemmed | Optimising the analysis of vascular prevention trials: Re-Assessment of the TARDIS trial, the first prevention trial to adopt an ordinal primary outcome measure |
| title_short | Optimising the analysis of vascular prevention trials: Re-Assessment of the TARDIS trial, the first prevention trial to adopt an ordinal primary outcome measure |
| title_sort | optimising the analysis of vascular prevention trials re assessment of the tardis trial the first prevention trial to adopt an ordinal primary outcome measure |
| topic | TARDIS Stroke Severity Outcome Time |
| url | http://www.sciencedirect.com/science/article/pii/S2451865423001321 |
| work_keys_str_mv | AT lisajwoodhouse optimisingtheanalysisofvascularpreventiontrialsreassessmentofthetardistrialthefirstpreventiontrialtoadoptanordinalprimaryoutcomemeasure AT alanamontgomery optimisingtheanalysisofvascularpreventiontrialsreassessmentofthetardistrialthefirstpreventiontrialtoadoptanordinalprimaryoutcomemeasure AT stuartpocock optimisingtheanalysisofvascularpreventiontrialsreassessmentofthetardistrialthefirstpreventiontrialtoadoptanordinalprimaryoutcomemeasure AT marilynjames optimisingtheanalysisofvascularpreventiontrialsreassessmentofthetardistrialthefirstpreventiontrialtoadoptanordinalprimaryoutcomemeasure AT annaranta optimisingtheanalysisofvascularpreventiontrialsreassessmentofthetardistrialthefirstpreventiontrialtoadoptanordinalprimaryoutcomemeasure AT philipmbath optimisingtheanalysisofvascularpreventiontrialsreassessmentofthetardistrialthefirstpreventiontrialtoadoptanordinalprimaryoutcomemeasure |