Impact on mortality and cancer incidence rates of using random invitation from population registers for recruitment to trials
Impact on mortality and cancer incidence rates of using random invitation from population registers for recruitment to trials
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DOI：
10.1186/1745-6215-12-61
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发表时间：
2011-03-01
期刊：
影响因子：
2.5
通讯作者：
Menon, Usha
中科院分区：
文献类型：
--
作者：
Burnell, Matthew;Gentry-Maharaj, Aleksandra;Menon, Usha
背景：评估预防干预措施（如筛查）的试验参与者平均比普通人群健康。为了减少这种“健康志愿者效应”（HVE），从人口登记册中随机邀请妇女参加英国卵巢癌筛查合作试验（UKCTOCS），不允许自我参考。本报告评估的程度HVE仍然普遍存在于UKCTOCS，并考虑如何在死亡率和发病率的某些不足，可以与社会经济地位的差异：方法：2001年至2005年，202 638绝经后妇女参加了试验的1 243 312名妇女随机邀请当地卫生当局登记。该队列被标记为死亡和癌症登记，删失时死亡率的平均随访时间为5.55年，癌症发病率为2.58年。根据国家死亡率（2005年）和癌症发病率（2006年）统计数据计算了总体和特定原因的标准化死亡率（SMR）和标准化发病率（SIR）。使用多重死亡指数（IMD 2007）评估社会经济地位与死亡率/癌症发病率之间的联系，以及邀请和招募人群之间的差异。结果：所有试验参与者的SMR为37%。按亚组划分，以下人群的SMR较高：年龄较轻的人群、BMI分布极端人群以及试验年份逐年增加的人群。有一个明显的趋势，较低的社会经济地位和死亡率增加，但不太明显的发病率。虽然邀请的人口有较高的平均IMD分数（更剥夺）比全国平均水平，那些谁加入了试验是不那么deprived.Conclusions：招聘筛选试验通过邀请人口登记并不能防止一个明显的HVE对死亡率。对癌症发病率的影响要小得多。在其他筛查RCT中也可能存在类似的不足，使用各种死亡率和发生率作为计算女性RCT事件率和把握度的指南可能是谨慎的。
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.