dc.contributor.author |
Elwood, James |
en |
dc.contributor.author |
Marshall, Roger |
en |
dc.contributor.author |
Tin Tin, Sandar |
en |
dc.contributor.author |
Barrios, Mark EP |
en |
dc.contributor.author |
Harvey, Vernon J |
en |
dc.date.accessioned |
2019-06-14T01:49:12Z |
en |
dc.date.issued |
2019-02 |
en |
dc.identifier.issn |
1877-7821 |
en |
dc.identifier.uri |
http://hdl.handle.net/2292/47026 |
en |
dc.description.abstract |
BACKGROUND:A requirement for consent for inclusion may bias the results from a clinical registry. This study gives a direct measure of this bias, based on a population-based clinical breast cancer registry where the requirement for consent was removed after further ethical review and data could be re-analysed. METHODS:In Auckland, New Zealand, the population-based clinical breast cancer registry required written patient consent for inclusion from 2000-2012. A subsequent ethical review removed this requirement and allowed an analysis of consented and non-consented patients. Kaplan-Meier survival to 10 years (mean follow-up 5.1 years, maximum 13.9 years), demographic and clinical characteristics were compared. Of 9244 women with invasive cancer, 926 (10.4%) were not consented, and of 1642 women with ductal carcinoma in situ, 245 (14.9%) were not consented. RESULTS:Survival was much higher for consenting patients; invasive cancer, 5 year survival 83.2% (95% confidence limits 82.2-84.1%) for consenting patients, 57.1% (53.0-60.9%) for non-consenting, and 80.8% in all patients. Analyses based only on consenting patients overestimate survival in all patients by around 2% at 2, 5, and 10 years. Non-consented patients were older, more often of Pacific ethnicity, had fewer screen-detected cancers, and more often had metastatic disease; they less frequently had primary surgery or systemic treatments. CONCLUSION:Data from a registry requiring active consent gives an upward bias in survival results, as non-consenting patients have more extensive disease, less treatment, and lower survival. To give unbiased results active consent should be not required in a clinical cancer registry. |
en |
dc.format.medium |
Print |
en |
dc.language |
eng |
en |
dc.relation.ispartofseries |
Cancer epidemiology |
en |
dc.rights |
Items in ResearchSpace are protected by copyright, with all rights reserved, unless otherwise indicated. Previously published items are made available in accordance with the copyright policy of the publisher. |
en |
dc.rights.uri |
https://researchspace.auckland.ac.nz/docs/uoa-docs/rights.htm |
en |
dc.title |
Bias in survival estimates created by a requirement for consent to enter a clinical breast cancer registry. |
en |
dc.type |
Journal Article |
en |
dc.identifier.doi |
10.1016/j.canep.2018.12.005 |
en |
pubs.begin-page |
178 |
en |
pubs.volume |
58 |
en |
dc.rights.holder |
Copyright: The author |
en |
pubs.end-page |
183 |
en |
pubs.publication-status |
Published |
en |
dc.rights.accessrights |
http://purl.org/eprint/accessRights/RestrictedAccess |
en |
pubs.subtype |
Journal Article |
en |
pubs.elements-id |
760492 |
en |
pubs.org-id |
Medical and Health Sciences |
en |
pubs.org-id |
Population Health |
en |
pubs.org-id |
Epidemiology & Biostatistics |
en |
dc.identifier.eissn |
1877-783X |
en |
pubs.record-created-at-source-date |
2019-01-15 |
en |
pubs.dimensions-id |
30639876 |
en |