Recruitment and representativeness of blood donors in the INTERVAL randomised trial assessing varying inter-donation intervals.
Recruitment and representativeness of blood donors in the INTERVAL randomised trial assessing varying inter-donation intervals.
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DOI：
10.1186/s13063-016-1579-7
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发表时间：
2016-09-20
期刊：
影响因子：
2.5
通讯作者：
Thompson SG
中科院分区：
文献类型：
--
作者：
Moore C;Bolton T;Walker M;Kaptoge S;Allen D;Daynes M;Mehenny S;Sambrook J;Watkins NA;Miflin G;Di Angelantonio E;Ouwehand WH;Roberts DJ;Danesh J;Thompson SG
对试验结果的解释可以通过理解它们对所要推断的目标人群的普遍性而得到帮助。INTERVAL是一项针对英国献血者的大型实用随机试验，旨在评估缩短献血间隔的有效性和安全性。该试验主要从血液服务的静态中心招募人员，这些中心只收集了10%的全血捐献。因此，该试验的参与者在多大程度上代表了一般的献血者群体是不确定的。我们将详细比较这两组。我们给出了从参与者邀请到随机化的CONSORT流程图。我们使用招募期间的国家血液供应“PULSE”数据库，将符合条件并同意参加INTERVAL的人群与普通献血者人群的特征进行比较。我们比较了从不同来源招募的特定试验参与者组的特征，以及随机分组与非随机分组的特征。在总共540 459份邀请中，48 725个捐助者有资格并同意参加间隔时间。这类捐助者的比例根据征聘来源的不同从1 - 22%不等。在种族、血型分布和最近因血红蛋白低而推迟献血的比率方面，同意者的特征与130万献血者的一般人群相似。然而，INTERVAL参与者包括更多的男性（50%对44%），年龄稍大（平均年龄43.1对42.3岁），包括较少的新献血者（3%对22%），并且在过去的2年中捐赠了更多的献血者（平均3.3对2.2）。在同意的参与者中，45263（93%）名捐赠者被随机分配。与未随机分配的供者相比，随机分配的供者表现出与上述供者类似的质量差异。尽管在年龄、性别和献血史上存在一些差异，但INTERVAL的参与者与英格兰的一般献血者人群有广泛的相似性。根据这些特征，试验结果的任何异质性都需要进行研究，以确保其对一般供体人群的普遍性。当前对照试验ISRCTN24760606。于2012年1月25日注册。本文的在线版本（doi:10.1186/s13063-016-1579-7）包含补充材料，仅供授权用户使用。
The interpretation of trial results can be helped by understanding how generalisable they are to the target population for which inferences are intended. INTERVAL, a large pragmatic randomised trial of blood donors in England, is assessing the effectiveness and safety of reducing inter-donation intervals. The trial recruited mainly from the blood service’s static centres, which collect only about 10 % of whole-blood donations. Hence, the extent to which the trial’s participants are representative of the general blood donor population is uncertain. We compare these groups in detail. We present the CONSORT flowchart from participant invitation to randomisation in INTERVAL. We compare the characteristics of those eligible and consenting to participate in INTERVAL with the general donor population, using the national blood supply ’PULSE’ database for the period of recruitment. We compare the characteristics of specific groups of trial participants recruited from different sources, as well as those who were randomised versus those not randomised. From a total of 540,459 invitations, 48,725 donors were eligible and consented to participate in INTERVAL. The proportion of such donors varied from 1–22 % depending on the source of recruitment. The characteristics of those consenting were similar to those of the general population of 1.3 million donors in terms of ethnicity, blood group distribution and recent deferral rates from blood donation due to low haemoglobin. However, INTERVAL participants included more men (50 % versus 44 %), were slightly older (mean age 43.1 versus 42.3 years), included fewer new donors (3 % versus 22 %) and had given more donations over the previous 2 years (mean 3.3 versus 2.2) than the general donor population. Of the consenting participants, 45,263 (93 %) donors were randomised. Compared to those not randomised, the randomised donors showed qualitatively similar differences to those described above. There was broad similarity of participants in INTERVAL with the general blood donor population of England, notwithstanding some differences in age, sex and donation history. Any heterogeneity of the trial’s results according to these characteristics will need to be studied to ensure its generalisability to the general donor population. Current Controlled Trials ISRCTN24760606. Registered on 25 January 2012. The online version of this article (doi:10.1186/s13063-016-1579-7) contains supplementary material, which is available to authorized users.
影响因子：
2.5
作者：
Moore C;Sambrook J;Walker M;Tolkien Z;Kaptoge S;Allen D;Mehenny S;Mant J;Di Angelantonio E;Thompson SG;Ouwehand W;Roberts DJ;Danesh J
通讯作者：
Danesh J
影响因子：
168.9
作者：
Williamson, Lorna M.;Devine, Dana V.
通讯作者：
Devine, Dana V.
影响因子：
1.8
作者：
Fendrich, Konstanze;Hoffmann, Wolfgang
通讯作者：
Hoffmann, Wolfgang