A methods review of posttrial follow-up studies of cardiovascular prevention finds potential biases in estimating legacy effects.

Zhu, L; Bell, KJL; Nayak, A; Hayen, A

A methods review of posttrial follow-up studies of cardiovascular prevention finds potential biases in estimating legacy effects.

Zhu, L Bell, KJL Nayak, A Hayen, A

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Publisher:: Elsevier
Publication Type:: Journal Article
Citation:: Journal of Clinical Epidemiology, 2021, 131, pp. 51-58
Issue Date:: 2021-03-01

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Field	Value	Language
dc.contributor.author	Zhu, L
dc.contributor.author	Bell, KJL
dc.contributor.author	Nayak, A
dc.contributor.author	Hayen, A https://orcid.org/0000-0003-4046-8030
dc.date.accessioned	2021-09-05T23:20:08Z
dc.date.available	2020-11-13
dc.date.available	2021-09-05T23:20:08Z
dc.date.issued	2021-03-01
dc.identifier.citation	Journal of Clinical Epidemiology, 2021, 131, pp. 51-58
dc.identifier.issn	0895-4356
dc.identifier.issn	1878-5921
dc.identifier.uri	http://hdl.handle.net/10453/150332
dc.description.abstract	The objective of the study was to assess the methods used, and potential for bias, in posttrial studies of cardiovascular disease (CVD) where legacy effects may be estimated.<h4>Study design and setting</h4>We undertook a methods review of posttrial studies after randomized controlled trials (RCTs) of interventions to prevent CVD. For each included article, we extracted information on important aspects of the design and analysis of the study, and on the reporting of legacy effects.<h4>Results</h4>Of 2,622 retrieved articles, 46 were included in the review: 13 on blood glucose control, 13 on blood pressure control, and 20 on blood lipid control. The median duration for the RCT and posttrial follow-up studies was 5.0 and 5.7 years, respectively. At least 80% of initial RCT participants were enrolled in the posttrial study in 32 of the reports. Most reports used both linkage to routine administrative data sources and active data collection for the posttrial study. Of the 46 included articles, the authors assessed and reported posttrial covariate balance in 29 and made statistical adjustments in the analysis for potential confounding in 25. Posttrial results were reported separately to overall results (from time of randomization) in 21 articles. Legacy effects were claimed in 19 reports, of which 16 could be justified on the basis of the posttrial results.<h4>Conclusion</h4>Posttrial studies may provide valuable information for investigating legacy effects, but better reporting of results is needed to realize their full potential. Robust methods of data collection and analysis may address the risk of selection and confounding biases in posttrial studies.
dc.format	Print-Electronic
dc.language	eng
dc.publisher	Elsevier
dc.relation.ispartof	Journal of Clinical Epidemiology
dc.relation.isbasedon	10.1016/j.jclinepi.2020.11.008
dc.rights	info:eu-repo/semantics/closedAccess
dc.subject	01 Mathematical Sciences, 11 Medical and Health Sciences
dc.subject.classification	Epidemiology
dc.title	A methods review of posttrial follow-up studies of cardiovascular prevention finds potential biases in estimating legacy effects.
dc.type	Journal Article
utslib.citation.volume	131
utslib.location.activity	United States
utslib.for	01 Mathematical Sciences
utslib.for	11 Medical and Health Sciences
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/Public Health
utslib.copyright.status	closed_access	*
pubs.consider-herdc	true
dc.date.updated	2021-09-05T23:20:07Z
pubs.publication-status	Published
pubs.volume	131

Abstract:

The objective of the study was to assess the methods used, and potential for bias, in posttrial studies of cardiovascular disease (CVD) where legacy effects may be estimated.

Study design and setting

We undertook a methods review of posttrial studies after randomized controlled trials (RCTs) of interventions to prevent CVD. For each included article, we extracted information on important aspects of the design and analysis of the study, and on the reporting of legacy effects.

Results

Of 2,622 retrieved articles, 46 were included in the review: 13 on blood glucose control, 13 on blood pressure control, and 20 on blood lipid control. The median duration for the RCT and posttrial follow-up studies was 5.0 and 5.7 years, respectively. At least 80% of initial RCT participants were enrolled in the posttrial study in 32 of the reports. Most reports used both linkage to routine administrative data sources and active data collection for the posttrial study. Of the 46 included articles, the authors assessed and reported posttrial covariate balance in 29 and made statistical adjustments in the analysis for potential confounding in 25. Posttrial results were reported separately to overall results (from time of randomization) in 21 articles. Legacy effects were claimed in 19 reports, of which 16 could be justified on the basis of the posttrial results.

Conclusion

Posttrial studies may provide valuable information for investigating legacy effects, but better reporting of results is needed to realize their full potential. Robust methods of data collection and analysis may address the risk of selection and confounding biases in posttrial studies.

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http://hdl.handle.net/10453/150332