Impact on mortality and cancer incidence rates of using random invitation from population registers for recruitment to trials View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2011-12

AUTHORS

Matthew Burnell, Aleksandra Gentry-Maharaj, Andy Ryan, Sophia Apostolidou, Mariam Habib, Jatinderpal Kalsi, Steven Skates, Mahesh Parmar, Mourad W Seif, Nazar N Amso, Keith Godfrey, David Oram, Jonathan Herod, Karin Williamson, Howard Jenkins, Tim Mould, Robert Woolas, John Murdoch, Stephen Dobbs, Simon Leeson, Derek Cruickshank, Stuart Campbell, Lesley Fallowfield, Ian Jacobs, Usha Menon

ABSTRACT

BACKGROUND: Participants in trials evaluating preventive interventions such as screening are on average healthier than the general population. To decrease this 'healthy volunteer effect' (HVE) women were randomly invited from population registers to participate in the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) and not allowed to self refer. This report assesses the extent of the HVE still prevalent in UKCTOCS and considers how certain shortfalls in mortality and incidence can be related to differences in socioeconomic status. METHODS: Between 2001 and 2005, 202 638 postmenopausal women joined the trial out of 1 243 312 women randomly invited from local health authority registers. The cohort was flagged for deaths and cancer registrations and mean follow up at censoring was 5.55 years for mortality, and 2.58 years for cancer incidence. Overall and cause-specific Standardised Mortality Ratios (SMRs) and Standardised Incidence Ratios (SIRs) were calculated based on national mortality (2005) and cancer incidence (2006) statistics. The Index of Multiple Deprivation (IMD 2007) was used to assess the link between socioeconomic status and mortality/cancer incidence, and differences between the invited and recruited populations. RESULTS: The SMR for all trial participants was 37%. By subgroup, the SMRs were higher for: younger age groups, extremes of BMI distribution and with each increasing year in trial. There was a clear trend between lower socioeconomic status and increased mortality but less pronounced with incidence. While the invited population had higher mean IMD scores (more deprived) than the national average, those who joined the trial were less deprived. CONCLUSIONS: Recruitment to screening trials through invitation from population registers does not prevent a pronounced HVE on mortality. The impact on cancer incidence is much smaller. Similar shortfalls can be expected in other screening RCTs and it maybe prudent to use the various mortality and incidence rates presented as guides for calculating event rates and power in RCTs involving women. More... »

PAGES

61

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/1745-6215-12-61

DOI

http://dx.doi.org/10.1186/1745-6215-12-61

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1017900227

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/21362184


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