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Generalisability of clinical registers used for drug safety and comparative effectiveness research: coverage of the Swedish Biologics Register

Neovius, M.; Simard, J. F.; Sundstrom, A.; Jacobsson, L; Geborek, Pierre LU ; Saxne, Tore LU ; Feltelius, N.; Klareskog, L. and Askling, J. (2011) In Annals of the Rheumatic Diseases 70(3). p.516-519
Abstract
Objective To determine coverage and generalisability of data in the Swedish Biologics Register ARTIS. Methods Patients with adult onset rheumatoid arthritis (RA) were identified in the National Patient Register and the Swedish Rheumatology Quality Register, including the ARTIS cohort of patients exposed to biological agents. Exposure to etanercept and adalimumab between 2006 and 2008 was determined by register linkage to the Prescribed Drug Register which contains patient-level data on >99% of all etanercept and adalimumab use in Sweden. Results Of 62 897 patients with RA, 6510 had received treatment with etanercept or adalimumab according to the Prescribed Drug Register. Of these, 5673 were also registered in ARTIS, resulting in a... (More)
Objective To determine coverage and generalisability of data in the Swedish Biologics Register ARTIS. Methods Patients with adult onset rheumatoid arthritis (RA) were identified in the National Patient Register and the Swedish Rheumatology Quality Register, including the ARTIS cohort of patients exposed to biological agents. Exposure to etanercept and adalimumab between 2006 and 2008 was determined by register linkage to the Prescribed Drug Register which contains patient-level data on >99% of all etanercept and adalimumab use in Sweden. Results Of 62 897 patients with RA, 6510 had received treatment with etanercept or adalimumab according to the Prescribed Drug Register. Of these, 5673 were also registered in ARTIS, resulting in a national coverage of 87%. The regional variation was small with >85% coverage in 18 of 21 counties. In multivariable analysis, ARTIS-registered and non-registered patients did not differ by age (p=0.62), sex (p=0.84) or education level (p=0.24). Conclusion Nationwide drug dispensing and demographic data may function as quality metrics for coverage and generalisability assessments. Using such data, the coverage of ARTIS was estimated at 87% with no indications of compromised external generalisability regarding demography. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Annals of the Rheumatic Diseases
volume
70
issue
3
pages
516 - 519
publisher
British Medical Association
external identifiers
  • wos:000286927800019
  • scopus:79951472502
ISSN
1468-2060
DOI
10.1136/ard.2010.130914
language
English
LU publication?
yes
id
7ed26ffb-2463-4ab3-a2e0-d936f3f1381b (old id 1876645)
date added to LUP
2011-04-01 11:18:28
date last changed
2017-09-10 04:04:05
@article{7ed26ffb-2463-4ab3-a2e0-d936f3f1381b,
  abstract     = {Objective To determine coverage and generalisability of data in the Swedish Biologics Register ARTIS. Methods Patients with adult onset rheumatoid arthritis (RA) were identified in the National Patient Register and the Swedish Rheumatology Quality Register, including the ARTIS cohort of patients exposed to biological agents. Exposure to etanercept and adalimumab between 2006 and 2008 was determined by register linkage to the Prescribed Drug Register which contains patient-level data on >99% of all etanercept and adalimumab use in Sweden. Results Of 62 897 patients with RA, 6510 had received treatment with etanercept or adalimumab according to the Prescribed Drug Register. Of these, 5673 were also registered in ARTIS, resulting in a national coverage of 87%. The regional variation was small with >85% coverage in 18 of 21 counties. In multivariable analysis, ARTIS-registered and non-registered patients did not differ by age (p=0.62), sex (p=0.84) or education level (p=0.24). Conclusion Nationwide drug dispensing and demographic data may function as quality metrics for coverage and generalisability assessments. Using such data, the coverage of ARTIS was estimated at 87% with no indications of compromised external generalisability regarding demography.},
  author       = {Neovius, M. and Simard, J. F. and Sundstrom, A. and Jacobsson, L and Geborek, Pierre and Saxne, Tore and Feltelius, N. and Klareskog, L. and Askling, J.},
  issn         = {1468-2060},
  language     = {eng},
  number       = {3},
  pages        = {516--519},
  publisher    = {British Medical Association},
  series       = {Annals of the Rheumatic Diseases},
  title        = {Generalisability of clinical registers used for drug safety and comparative effectiveness research: coverage of the Swedish Biologics Register},
  url          = {http://dx.doi.org/10.1136/ard.2010.130914},
  volume       = {70},
  year         = {2011},
}