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Reliability of major bleeding events in UK routine data versus clinical trial adjudicated follow-up data
OBJECTIVE: To assess how reliable UK routine data are for ascertaining major bleeding events compared with adjudicated follow-up. METHODS: The ASCEND (A Study of Cardiovascular Events iN Diabetes) primary prevention trial randomised 15 480 UK people with diabetes to aspirin versus matching placebo....
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10511984/ https://www.ncbi.nlm.nih.gov/pubmed/37270201 http://dx.doi.org/10.1136/heartjnl-2023-322616 |
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author | Harper, Charlie Mafham, Marion Herrington, William Staplin, Natalie Stevens, William Wallendszus, Karl Haynes, Richard Landray, Martin J Parish, Sarah Bowman, Louise Armitage, Jane |
author_facet | Harper, Charlie Mafham, Marion Herrington, William Staplin, Natalie Stevens, William Wallendszus, Karl Haynes, Richard Landray, Martin J Parish, Sarah Bowman, Louise Armitage, Jane |
author_sort | Harper, Charlie |
collection | PubMed |
description | OBJECTIVE: To assess how reliable UK routine data are for ascertaining major bleeding events compared with adjudicated follow-up. METHODS: The ASCEND (A Study of Cardiovascular Events iN Diabetes) primary prevention trial randomised 15 480 UK people with diabetes to aspirin versus matching placebo. The primary safety outcome was major bleeding (including intracranial haemorrhage, sight-threatening eye bleeding, serious gastrointestinal bleeding and other major bleeding (epistaxis, haemoptysis, haematuria, vaginal and other bleeding)) ascertained by direct-participant mail-based follow-up, with >90% of outcomes undergoing adjudication. Nearly all participants were linked to routinely collected hospitalisation and death data (ie, routine data). An algorithm categorised bleeding events from routine data as major/minor. Kappa statistics were used to assess agreement between data sources, and randomised comparisons were re-run using routine data. RESULTS: When adjudicated follow-up and routine data were compared, there was agreement for 318 major bleeding events, with routine data identifying 281 additional-potential events, and not identifying 241 participant-reported events (kappa 0.53, 95% CI 0.49 to 0.57). Repeating ASCEND’s randomised comparisons using routine data only found estimated relative and absolute effects of allocation to aspirin versus placebo on major bleeding similar to adjudicated follow-up (adjudicated follow-up: aspirin 314 (4.1%) vs placebo 245 (3.2%); rate ratio (RR) 1.29, 95% CI 1.09 to 1.52; absolute excess +6.3/5000 person-years (mean SE±2.1); vs routine data: 327 (4.2%) vs 272 (3.5%); RR 1.21, 95% CI 1.03 to 1.41; absolute excess +5.0/5000 (±2.2)). CONCLUSIONS: Analyses of the ASCEND randomised trial found that major bleeding events ascertained via UK routine data sources provided relative and absolute treatment effects similar to adjudicated follow-up. TRIAL REGISTRATION NUMBER: ISRCTN60635500; NCT00135226. |
format | Online Article Text |
id | pubmed-10511984 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-105119842023-09-22 Reliability of major bleeding events in UK routine data versus clinical trial adjudicated follow-up data Harper, Charlie Mafham, Marion Herrington, William Staplin, Natalie Stevens, William Wallendszus, Karl Haynes, Richard Landray, Martin J Parish, Sarah Bowman, Louise Armitage, Jane Heart Study Design OBJECTIVE: To assess how reliable UK routine data are for ascertaining major bleeding events compared with adjudicated follow-up. METHODS: The ASCEND (A Study of Cardiovascular Events iN Diabetes) primary prevention trial randomised 15 480 UK people with diabetes to aspirin versus matching placebo. The primary safety outcome was major bleeding (including intracranial haemorrhage, sight-threatening eye bleeding, serious gastrointestinal bleeding and other major bleeding (epistaxis, haemoptysis, haematuria, vaginal and other bleeding)) ascertained by direct-participant mail-based follow-up, with >90% of outcomes undergoing adjudication. Nearly all participants were linked to routinely collected hospitalisation and death data (ie, routine data). An algorithm categorised bleeding events from routine data as major/minor. Kappa statistics were used to assess agreement between data sources, and randomised comparisons were re-run using routine data. RESULTS: When adjudicated follow-up and routine data were compared, there was agreement for 318 major bleeding events, with routine data identifying 281 additional-potential events, and not identifying 241 participant-reported events (kappa 0.53, 95% CI 0.49 to 0.57). Repeating ASCEND’s randomised comparisons using routine data only found estimated relative and absolute effects of allocation to aspirin versus placebo on major bleeding similar to adjudicated follow-up (adjudicated follow-up: aspirin 314 (4.1%) vs placebo 245 (3.2%); rate ratio (RR) 1.29, 95% CI 1.09 to 1.52; absolute excess +6.3/5000 person-years (mean SE±2.1); vs routine data: 327 (4.2%) vs 272 (3.5%); RR 1.21, 95% CI 1.03 to 1.41; absolute excess +5.0/5000 (±2.2)). CONCLUSIONS: Analyses of the ASCEND randomised trial found that major bleeding events ascertained via UK routine data sources provided relative and absolute treatment effects similar to adjudicated follow-up. TRIAL REGISTRATION NUMBER: ISRCTN60635500; NCT00135226. BMJ Publishing Group 2023-10 2023-06-03 /pmc/articles/PMC10511984/ /pubmed/37270201 http://dx.doi.org/10.1136/heartjnl-2023-322616 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Study Design Harper, Charlie Mafham, Marion Herrington, William Staplin, Natalie Stevens, William Wallendszus, Karl Haynes, Richard Landray, Martin J Parish, Sarah Bowman, Louise Armitage, Jane Reliability of major bleeding events in UK routine data versus clinical trial adjudicated follow-up data |
title | Reliability of major bleeding events in UK routine data versus clinical trial adjudicated follow-up data |
title_full | Reliability of major bleeding events in UK routine data versus clinical trial adjudicated follow-up data |
title_fullStr | Reliability of major bleeding events in UK routine data versus clinical trial adjudicated follow-up data |
title_full_unstemmed | Reliability of major bleeding events in UK routine data versus clinical trial adjudicated follow-up data |
title_short | Reliability of major bleeding events in UK routine data versus clinical trial adjudicated follow-up data |
title_sort | reliability of major bleeding events in uk routine data versus clinical trial adjudicated follow-up data |
topic | Study Design |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10511984/ https://www.ncbi.nlm.nih.gov/pubmed/37270201 http://dx.doi.org/10.1136/heartjnl-2023-322616 |
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