PROState Pathway Embedded Comparative Trial: The IP3-PROSPECT study.
PROState Pathway Embedded Comparative Trial: The IP3-PROSPECT study.
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DOI：
10.1016/j.cct.2021.106485
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发表时间：
2021-08
影响因子：
2.2
通讯作者：
Ahmed HU
中科院分区：
文献类型：
--
作者：
Bass EJ;Klimowska-Nassar N;Sasikaran T;Day E;Fiorentino F;Sydes MR;Winkler M;Arumainayagam N;Khoubehi B;Pope A;Sokhi H;Dudderidge T;Ahmed HU
传统的双盲随机对照试验是试验设计的“黄金标准”。由于各种原因，这些设计往往无法吸引足够多的参与者来得出结论。这在局限性前列腺癌中尤其具有挑战性。队列多随机对照试验(CmRCT)试验设计可能代表了一种在前列腺癌中提供强有力的比较数据的替代方法。IP3-PROSPECT是一项cmRCT，旨在测试一个队列中符合条件的男性的多种前列腺癌干预措施。设计的关键是两点同意。首先，在征得同意的情况下，被转介进行前列腺癌调查的男性被邀请加入队列。然后，他们可能会在稍后的日期被随机邀请，以考虑在第二次同意时进行干预。在试点阶段，我们将测试发展队列的可接受性和可行性。这项研究的可接受性和可行性将通过定量和定性相结合的方法来衡量。主要的结果衡量标准是同意纳入IP3-前景队列的比率。次要结果衡量标准包括现场数据收集的完整性和患者问卷的返回率。我们还将采访患者和医疗保健专业人员，探讨他们对IP3-PROSPECT的实施、实用性和效率的看法。IP3-PROCESS研究将评估前列腺癌的cmRCT设计。最初，我们将试行设计，评估可接受性和可行性。CmRCT是一种创新的设计，为建立前列腺癌的现代比较证据基础提供了可能性。
The traditional double blind RCT is the ‘gold standard’ trial design. For a variety of reasons, these designs often fail to accrue enough participants to conclude. This is particularly challenging in localized prostate cancer. The cohort multiple randomised controlled trial (cmRCT) trial design may represent an alternative approach to delivering robust comparative data in prostate cancer. IP3-PROSPECT is a cmRCT designed to test multiple prostate cancer interventions from eligible men in one cohort. Key to the design is two points of consent. First, at point of consent one, men referred for prostate cancer investigations are invited to join the cohort. They may then be randomly invited at a later date to consider an intervention at point of consent two. In the pilot phase we will test the acceptability and feasibility of developing the cohort. Acceptability and feasibility of the study will be measured by a combination of quantitative and qualitative methods. The primary outcome measure is the rate of consent to inclusion to the IP3-PROSPECT cohort. Secondary outcome measures include the completeness of data collection at sites and return rates of patient questionnaires. We will also interview patients and healthcare professionals to explore their thoughts on the implementation, practicality and efficiency of IP3-PROSPECT. The IP3-PROSPECT study will evaluate the cmRCT design in prostate cancer. Initially we will pilot the design, assessing for acceptability and feasibility. The cmRCT is an innovative design that offers potential for building a modern comparative evidence base for prostate cancer.
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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：
4.5
作者：
Kearns, Benjamin;Ara, Roberta;Relton, Clare
通讯作者：
Relton, Clare
影响因子：
2.9
作者：
Cockayne, Sarah;Adamson, Joy;Torgerson, David
通讯作者：
Torgerson, David
影响因子：
158.5
作者：
Bill-Axelson, Anna;Holmberg, Lars;Johansson, Jan-Erik
通讯作者：
Johansson, Jan-Erik
制定和评估复杂的干预措施：新的医学研究委员会指南。
DOI：
10.1136/bmj.a1655
发表时间：
2008-09-29
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Craig P;Dieppe P;Macintyre S;Michie S;Nazareth I;Petticrew M;Medical Research Council Guidance
通讯作者：
Medical Research Council Guidance