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

被引：36

作者：

Burnell, Matthew ^{[1
]}

Gentry-Maharaj, Aleksandra ^{[1
]}

Ryan, Andy ^{[1
]}

Apostolidou, Sophia ^{[1
]}

Habib, Mariam ^{[1
]}

Kalsi, Jatinderpal ^{[1
]}

Skates, Steven ^{[2
]}

Parmar, Mahesh ^{[3
]}

Seif, Mourad W. ^{[4
]}

Amso, Nazar N. ^{[5
]}

Godfrey, Keith ^{[6
]}

Oram, David ^{[7
]}

Herod, Jonathan ^{[8
]}

Williamson, Karin ^{[9
]}

Jenkins, Howard ^{[10
]}

Mould, Tim ^{[11
]}

Woolas, Robert ^{[12
]}

Murdoch, John ^{[13
]}

Dobbs, Stephen ^{[14
]}

Leeson, Simon ^{[15
]}

Cruickshank, Derek ^{[16
]}

Campbell, Stuart ^{[17
]}

Fallowfield, Lesley ^{[18
]}

Jacobs, Ian ^{[1
]}

Menon, Usha ^{[1
]}

机构：

[1] UCL EGA Inst Womens Hlth, London W1T 7DN, England

[2] Harvard Univ, Sch Med, Dept Med, Boston, MA 02115 USA

[3] MRC, Clin Trials Unit, London NW1 2DA, England

[4] St Marys Hosp, Acad Unit Obstet & Gynaecol, Manchester M13 9WL, Lancs, England

[5] Cardiff Univ, Wales Coll Med, Dept Obstet & Gynaecol, Cardiff CF14 4XN, S Glam, Wales

[6] Queen Elizabeth Hosp, No Gynaecol Oncol Ctr, Gateshead NE9 6SX, England

[7] St Bartholomews Hosp, Dept Gynaecol Oncol, London EC1A 7BE, England

[8] Liverpool Womens Hosp, Dept Gynaecol, Liverpool L8 7SS, Merseyside, England

[9] City Hosp Nottingham, Dept Gynaecol Oncol, Nottingham NG5 1PB, England

[10] Derby City Hosp, Dept Gynaecol Oncol, Derby DE22 3NE, England

[11] Royal Free Hosp, Dept Gynaecol Oncol, London NW3 2QG, England

[12] St Marys Hosp, Dept Gynaecol Oncol, Portsmouth PO3 6AD, Hants, England

[13] St Michaels Hosp, Dept Gynaecol Oncol, Bristol BS2 8EG, Avon, England

[14] Belfast City Hosp, Dept Gynaecol Oncol, Belfast BT9 7AB, Antrim, North Ireland

[15] Llandudno Hosp, Dept Gynaecol Oncol, Llandudno LL30 1LB, Wales

[16] James Cook Univ Hosp, Dept Gynaecol Oncol, Middlesbrough TS4 3BW, Cleveland, England

[17] Create Hlth Clin, London W1G 6AJ, England

[18] Univ Sussex, Psychosocial Oncol Grp, Brighton BN1 9QG, E Sussex, England

来源：

TRIALS | 2011年 / 12卷

基金：

英国医学研究理事会;

关键词：

BODY-MASS INDEX; EARLY BILATERAL OOPHORECTOMY; SOCIOECONOMIC-STATUS; PREVENTION TRIALS; SCREENING TRIAL; LUNG; EPIDEMIOLOGY; BREAST; ASSOCIATION; DEPRIVATION;

D O I：

10.1186/1745-6215-12-61

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

100103 [病原生物学]; 100218 [急诊医学];

摘要：

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.

引用

页数：10

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