Harmonization of large-scale, heterogeneous individual participant adverse event data from randomized trials of statin therapy
<p><strong>Background:</strong> Meta-analyses of individual-level data from randomized trials are often required to detect clinically worthwhile effects. The Cholesterol Treatment Trialists’ Collaboration, which includes data from numerous large long-term statin trials, is conduct...
| Main Authors: | , , , , , , , , , , , , , |
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| Other Authors: | |
| Format: | Journal article |
| Language: | English |
| Published: |
SAGE Publications
2022
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| _version_ | 1797108405566963712 |
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| author | Emberson, J Spata, E Blackwell, L Davies, K Halls, H Harper, C Roddick, A Samuel, N Stevens, W Wallendszus, K Preiss, D Collins, R Baigent, C Reith, C |
| author2 | Cholesterol Treatment Trialists’ Collaboration |
| author_facet | Cholesterol Treatment Trialists’ Collaboration Emberson, J Spata, E Blackwell, L Davies, K Halls, H Harper, C Roddick, A Samuel, N Stevens, W Wallendszus, K Preiss, D Collins, R Baigent, C Reith, C |
| author_sort | Emberson, J |
| collection | OXFORD |
| description | <p><strong>Background:</strong> Meta-analyses of individual-level data from randomized trials are often required to detect clinically worthwhile effects. The Cholesterol Treatment Trialists’
Collaboration, which includes data from numerous large long-term statin trials, is
conducting a review of the effects of statin therapy on all adverse events collected in
those trials. This paper describes the approaches used and challenges faced to
systematically capture and categorise the data.</p>
<p><strong>Methods:</strong> Protocols, statistical analysis plans, case report forms, clinical study reports and data sets were obtained, reviewed and checked. Relevant baseline and
follow-up data from each trial was then reorganised into standardised formats based
upon the Clinical Data Interchange Standards Consortium Study Data Tabulation
Model (CDISC SDTM). Adverse event data were organised and coded (automatically
or, where necessary, manually) according to a common medical dictionary based
upon the Medical Dictionary for Regulatory Activities (MedDRA).</p>
<p><strong>Results:</strong> Data from 23 double-blind statin trials and 5 open-label statin trials were provided, either through direct data transfer or through online access portals.
Together, these trials provided 845 datasets containing over 38 million records
relating to 30,495 study variables and 181,973 randomized patients. Of the 46
CDISC SDTM domains that could potentially have been used to organise the data,
the 13 most relevant to the project were identified and utilised, including 6 domains
related to post-randomization adverse events. Nearly 1.2 million adverse events
were extracted and mapped to over 45,000 unique adverse event terms. Of these
adverse events, 99% were coded to a MedDRA ‘lower level term’, with the remainder
coded to a ‘higher level term’ or, very rarely, only a ‘higher level group term’.</p>
<p><strong>Conclusions:</strong> In this meta-analysis of adverse event data from the large randomized trials of statins, approaches based on common standards for data organisation and
classification have provided a resource capable of allowing reliable and rapid
evaluation of any previously-unknown benefits or hazards of statin therapy.</p> |
| first_indexed | 2024-03-07T07:28:45Z |
| format | Journal article |
| id | oxford-uuid:5bb8b207-1360-43e8-bd4b-fc33e5d52161 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T07:28:45Z |
| publishDate | 2022 |
| publisher | SAGE Publications |
| record_format | dspace |
| spelling | oxford-uuid:5bb8b207-1360-43e8-bd4b-fc33e5d521612022-12-19T08:56:04ZHarmonization of large-scale, heterogeneous individual participant adverse event data from randomized trials of statin therapyJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:5bb8b207-1360-43e8-bd4b-fc33e5d52161EnglishSymplectic ElementsSAGE Publications2022Emberson, JSpata, EBlackwell, LDavies, KHalls, HHarper, CRoddick, ASamuel, NStevens, WWallendszus, KPreiss, DCollins, RBaigent, CReith, CCholesterol Treatment Trialists’ Collaboration<p><strong>Background:</strong> Meta-analyses of individual-level data from randomized trials are often required to detect clinically worthwhile effects. The Cholesterol Treatment Trialists’ Collaboration, which includes data from numerous large long-term statin trials, is conducting a review of the effects of statin therapy on all adverse events collected in those trials. This paper describes the approaches used and challenges faced to systematically capture and categorise the data.</p> <p><strong>Methods:</strong> Protocols, statistical analysis plans, case report forms, clinical study reports and data sets were obtained, reviewed and checked. Relevant baseline and follow-up data from each trial was then reorganised into standardised formats based upon the Clinical Data Interchange Standards Consortium Study Data Tabulation Model (CDISC SDTM). Adverse event data were organised and coded (automatically or, where necessary, manually) according to a common medical dictionary based upon the Medical Dictionary for Regulatory Activities (MedDRA).</p> <p><strong>Results:</strong> Data from 23 double-blind statin trials and 5 open-label statin trials were provided, either through direct data transfer or through online access portals. Together, these trials provided 845 datasets containing over 38 million records relating to 30,495 study variables and 181,973 randomized patients. Of the 46 CDISC SDTM domains that could potentially have been used to organise the data, the 13 most relevant to the project were identified and utilised, including 6 domains related to post-randomization adverse events. Nearly 1.2 million adverse events were extracted and mapped to over 45,000 unique adverse event terms. Of these adverse events, 99% were coded to a MedDRA ‘lower level term’, with the remainder coded to a ‘higher level term’ or, very rarely, only a ‘higher level group term’.</p> <p><strong>Conclusions:</strong> In this meta-analysis of adverse event data from the large randomized trials of statins, approaches based on common standards for data organisation and classification have provided a resource capable of allowing reliable and rapid evaluation of any previously-unknown benefits or hazards of statin therapy.</p> |
| spellingShingle | Emberson, J Spata, E Blackwell, L Davies, K Halls, H Harper, C Roddick, A Samuel, N Stevens, W Wallendszus, K Preiss, D Collins, R Baigent, C Reith, C Harmonization of large-scale, heterogeneous individual participant adverse event data from randomized trials of statin therapy |
| title | Harmonization of large-scale, heterogeneous individual participant adverse event data from randomized trials of statin therapy |
| title_full | Harmonization of large-scale, heterogeneous individual participant adverse event data from randomized trials of statin therapy |
| title_fullStr | Harmonization of large-scale, heterogeneous individual participant adverse event data from randomized trials of statin therapy |
| title_full_unstemmed | Harmonization of large-scale, heterogeneous individual participant adverse event data from randomized trials of statin therapy |
| title_short | Harmonization of large-scale, heterogeneous individual participant adverse event data from randomized trials of statin therapy |
| title_sort | harmonization of large scale heterogeneous individual participant adverse event data from randomized trials of statin therapy |
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