Design and preliminary recruitment results of the Cluster randomised triAl of PSA testing for Prostate cancer (CAP).
Design and preliminary recruitment results of the Cluster randomised triAl of PSA testing for Prostate cancer (CAP).
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DOI：
10.1038/bjc.2014.242
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发表时间：
2014-06-10
影响因子：
8.8
通讯作者：
Martin, R. M.
中科院分区：
文献类型：
--
作者：
Turner, E. L.;Metcalfe, C.;Donovan, J. L.;Noble, S.;Sterne, J. A. C.;Lane, J. A.;Avery, K. N.;Down, L.;Walsh, E.;Davis, M.;Ben-Shlomo, Y.;Oliver, S. E.;Evans, S.;Brindle, P.;Williams, N. J.;Hughes, L. J.;Hill, E. M.;Davies, C.;Ng, S. Y.;Neal, D. E.;Hamdy, F. C.;Martin, R. M.
由于担心过度诊断和不必要的治疗，前列腺癌的筛查继续产生争议。我们描述了PSA检测前列腺癌（CAP）试验的分组随机试验的原理、设计和招募，该试验是一项英国范围内的分组随机对照试验，旨在研究前列腺特异性抗原（PSA）检测的有效性和成本效益。在英格兰和威尔士，785名全科医生（GP）被随机分配到基于人群的PSA检测或标准护理，然后获得参与同意。在干预组中，50-69岁的男性被邀请接受PSA检测，而那些被诊断患有局部前列腺癌的人被邀请参加治疗试验。管制部门的做法采用了标准的联合王国管理办法。所有男子都被卫生和社会保健信息中心标记为死亡和癌症登记。主要结局是中位10年随访时的前列腺癌死亡率。在随机化实践中，干预组（198114例男性）和对照组（221929例男性）分别有271例（68%）和302例（78%）患者同意参加，符合预先规定的功率要求。几乎没有证据表明试验组之间在知情同意的GP实践（或这些实践中的男性）的测量基线特征方面存在差异。CAP试验成功地达到了招募目标，并将为基于PSA的前列腺癌筛查的国际理解做出重要贡献。
Screening for prostate cancer continues to generate controversy because of concerns about over-diagnosis and unnecessary treatment. We describe the rationale, design and recruitment of the Cluster randomised triAl of PSA testing for Prostate cancer (CAP) trial, a UK-wide cluster randomised controlled trial investigating the effectiveness and cost-effectiveness of prostate-specific antigen (PSA) testing. Seven hundred and eighty-five general practitioner (GP) practices in England and Wales were randomised to a population-based PSA testing or standard care and then approached for consent to participate. In the intervention arm, men aged 50–69 years were invited to undergo PSA testing, and those diagnosed with localised prostate cancer were invited into a treatment trial. Control arm practices undertook standard UK management. All men were flagged with the Health and Social Care Information Centre for deaths and cancer registrations. The primary outcome is prostate cancer mortality at a median 10-year-follow-up. Among randomised practices, 271 (68%) in the intervention arm (198 114 men) and 302 (78%) in the control arm (221 929 men) consented to participate, meeting pre-specified power requirements. There was little evidence of differences between trial arms in measured baseline characteristics of the consenting GP practices (or men within those practices). The CAP trial successfully met its recruitment targets and will make an important contribution to international understanding of PSA-based prostate cancer screening.
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影响因子：
168.9
作者：
Frankel, S;Smith, GD;Neal, D
通讯作者：
Neal, D
影响因子：
6.4
作者：
de Koning, HJ;Liem, MK;Alexander, FE
通讯作者：
Alexander, FE
DOI：
10.1056/nejmoa1201637
发表时间：
2012-08-16
期刊：
The New England journal of medicine
影响因子：
--
作者：
Heijnsdijk EA;Wever EM;Auvinen A;Hugosson J;Ciatto S;Nelen V;Kwiatkowski M;Villers A;Páez A;Moss SM;Zappa M;Tammela TL;Mäkinen T;Carlsson S;Korfage IJ;Essink-Bot ML;Otto SJ;Draisma G;Bangma CH;Roobol MJ;Schröder FH;de Koning HJ
通讯作者：
de Koning HJ
影响因子：
8.4
作者：
Lane, J. A.;Hamdy, F. C.;Donovan, J. L.
通讯作者：
Donovan, J. L.
影响因子：
7.2
作者：
Gulati, Roman;Mariotto, Angela B.;Etzioni, Ruth
通讯作者：
Etzioni, Ruth