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The effect of adherence to statin therapy on cardiovascular mortality : quantification of unmeasured bias using falsification end-points

Maarten J Bijlsma, Stijn Vansteelandt UGent, Fanny Janssen and Eelko Hak (2016) BMC PUBLIC HEALTH. 16.
abstract
Background: To determine the clinical effectiveness of statins on cardiovascular mortality in practice, observational studies are needed. Control for confounding is essential in any observational study. Falsification end-points may be useful to determine if bias is present after adjustment has taken place. Methods: We followed starters on statin therapy in the Netherlands aged 46 to 100 years over the period 1996 to 2012, from initiation of statin therapy until cardiovascular mortality or censoring. Within this group (n = 49,688, up to 16 years of follow-up), we estimated the effect of adherence to statin therapy (0 = completely non-adherent, 1 = fully adherent) on ischemic heart diseases and cerebrovascular disease (ICD10-codes I20-I25 and I60-I69) as well as respiratory and endocrine disease mortality (ICD10-codes J00-J99 and E00-E90) as falsification end points, controlling for demographic factors, socio-economic factors, birth cohort, adherence to other cardiovascular medications, and diabetes using time-varying Cox regression models. Results: Falsification end-points indicated that a simpler model was less biased than a model with more controls. Adherence to statins appeared to be protective against cardiovascular mortality (HR: 0.70, 95 % CI 0.61 to 0.81). Conclusions: Falsification end-points helped detect overadjustment bias or bias due to competing risks, and thereby proved to be a useful technique in such a complex setting.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
Statin therapy, Cardiovascular, Mortality, Bias, Overadjustment, Falsification end-points, 7 EUROPEAN COUNTRIES, COHORT, TRENDS, POPULATION, DISEASE, MODELS, PERIOD, HEALTH, TRIAL, RATES
journal title
BMC PUBLIC HEALTH
BMC Public Health
volume
16
article number
303
pages
8 pages
Web of Science type
Article
Web of Science id
000373711600001
ISSN
1471-2458
DOI
10.1186/s12889-016-2986-0
language
English
UGent publication?
yes
classification
A1
copyright statement
Creative Commons Attribution 4.0 International Public License (CC-BY 4.0)
id
8507230
handle
http://hdl.handle.net/1854/LU-8507230
date created
2017-02-02 23:04:14
date last changed
2017-02-20 14:12:33
@article{8507230,
  abstract     = {Background: To determine the clinical effectiveness of statins on cardiovascular mortality in practice, observational studies are needed. Control for confounding is essential in any observational study. Falsification end-points may be useful to determine if bias is present after adjustment has taken place. 
Methods: We followed starters on statin therapy in the Netherlands aged 46 to 100 years over the period 1996 to 2012, from initiation of statin therapy until cardiovascular mortality or censoring. Within this group (n = 49,688, up to 16 years of follow-up), we estimated the effect of adherence to statin therapy (0 = completely non-adherent, 1 = fully adherent) on ischemic heart diseases and cerebrovascular disease (ICD10-codes I20-I25 and I60-I69) as well as respiratory and endocrine disease mortality (ICD10-codes J00-J99 and E00-E90) as falsification end points, controlling for demographic factors, socio-economic factors, birth cohort, adherence to other cardiovascular medications, and diabetes using time-varying Cox regression models. 
Results: Falsification end-points indicated that a simpler model was less biased than a model with more controls. Adherence to statins appeared to be protective against cardiovascular mortality (HR: 0.70, 95 \% CI 0.61 to 0.81). 
Conclusions: Falsification end-points helped detect overadjustment bias or bias due to competing risks, and thereby proved to be a useful technique in such a complex setting.},
  articleno    = {303},
  author       = {Bijlsma, Maarten J and Vansteelandt, Stijn and Janssen, Fanny and Hak, Eelko},
  issn         = {1471-2458},
  journal      = {BMC PUBLIC HEALTH},
  keyword      = {Statin therapy,Cardiovascular,Mortality,Bias,Overadjustment,Falsification end-points,7 EUROPEAN COUNTRIES,COHORT,TRENDS,POPULATION,DISEASE,MODELS,PERIOD,HEALTH,TRIAL,RATES},
  language     = {eng},
  pages        = {8},
  title        = {The effect of adherence to statin therapy on cardiovascular mortality : quantification of unmeasured bias using falsification end-points},
  url          = {http://dx.doi.org/10.1186/s12889-016-2986-0},
  volume       = {16},
  year         = {2016},
}

Chicago
Bijlsma, Maarten J, Stijn Vansteelandt, Fanny Janssen, and Eelko Hak. 2016. “The Effect of Adherence to Statin Therapy on Cardiovascular Mortality : Quantification of Unmeasured Bias Using Falsification End-points.” Bmc Public Health 16.
APA
Bijlsma, M. J., Vansteelandt, S., Janssen, F., & Hak, E. (2016). The effect of adherence to statin therapy on cardiovascular mortality : quantification of unmeasured bias using falsification end-points. BMC PUBLIC HEALTH, 16.
Vancouver
1.
Bijlsma MJ, Vansteelandt S, Janssen F, Hak E. The effect of adherence to statin therapy on cardiovascular mortality : quantification of unmeasured bias using falsification end-points. BMC PUBLIC HEALTH. 2016;16.
MLA
Bijlsma, Maarten J, Stijn Vansteelandt, Fanny Janssen, et al. “The Effect of Adherence to Statin Therapy on Cardiovascular Mortality : Quantification of Unmeasured Bias Using Falsification End-points.” BMC PUBLIC HEALTH 16 (2016): n. pag. Print.