Cost-effective recruitment methods for a large randomised trial in people with diabetes: A Study of Cardiovascular Events iN Diabetes (ASCEND).
Cost-effective recruitment methods for a large randomised trial in people with diabetes: A Study of Cardiovascular Events iN Diabetes (ASCEND).
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DOI：
10.1186/s13063-016-1354-9
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发表时间：
2016-06-13
期刊：
影响因子：
2.5
通讯作者：
ASCEND Study Collaborative Group
中科院分区：
文献类型：
--
作者：
Aung T;Haynes R;Barton J;Cox J;Murawska A;Murphy K;Lay M;Armitage J;Bowman L;ASCEND Study Collaborative Group
临床试验需要具有成本效益的方法来识别、随机和跟踪大量的人，以便产生可靠的证据。ASCED(糖尿病心血管事件研究)是一项对阿司匹林和omega-3脂肪酸补充剂用于糖尿病患者心血管事件一级预防的随机“2×2因子设计”研究；这项研究使用中央疾病登记和基于邮件的方法来识别、随机和跟踪15,000人。在与英国顾问和全科医生(GP)的合作下，研究人员从中央持有的登记(例如视网膜病变筛查)和全科医生持有的疾病登记中确定了潜在的符合条件的糖尿病患者。根据2006年《国家卫生服务法》第251条(前身为2001年《国民保健服务法》第60条)获得许可，允许以登记簿持有人的名义集中发出邀请函。此外，在国家卫生研究院(NIHR)糖尿病和初级保健研究网络(DRN和PCRN)的合作下，全科医生向诊断为糖尿病的人发送了预先组装的邀请函。邀请函包括求职信、筛选问卷(附同意书)、资料传单和免费邮寄信封。符合条件的患者进入为期2个月的安慰剂片剂随机前磨合阶段，只有在他们完成随机表并在磨合结束时保持意愿和资格的情况下才被随机化。后续行动正在进行中，使用的是以邮件为基础的办法，并得到中央登记册数据的补充。获得了58个中央保存的糖尿病登记名单上约60万人的信息，300,188名潜在符合条件的患者被邀请参加这项研究。此外，785家全科医生诊所向120,875名患者发出了邀请。另有2340名潜在研究参与者通过其他途径被确定。总共有423,403名糖尿病患者被邀请参加；26,462人进入了为期2个月的随机前磨合阶段；15,480人被随机分配。如果能够集中确定足够数量的符合条件的潜在患者，并且试验治疗不要求参与者到诊所就诊，则通过邮寄方式招募和跟进患者是可行和具有成本效益的。更广泛地使用这些方法可以使更多的大型随机试验成功地进行，并具有成本效益。当前对照试验，ISRCTN60635500，注册于2005年7月14日本文的在线版本(DOI：10.1186/s13063-016-1354-9)包含补充材料，授权用户可用。
Clinical trials require cost-effective methods for identifying, randomising, and following large numbers of people in order to generate reliable evidence. ASCEND (A Study of Cardiovascular Events iN Diabetes) is a randomised ‘2 × 2 factorial design’ study of aspirin and omega-3 fatty acid supplements for the primary prevention of cardiovascular events in people with diabetes; this study used central disease registers and a mail-based approach to identify, randomise, and follow 15,000 people. In collaboration with UK consultants and general practitioners (GPs), researchers identified potentially eligible people with diabetes from centrally held registers (e.g. for retinopathy screening) and GP-held disease registers. Permission was obtained under section 251 of the National Health Service Act 2006 (previously section 60 of the NHS act 2001) to allow invitation letters to be generated centrally in the name of the holder of the register. In addition, with the collaboration of the National Institutes for Health Research (NIHR) Diabetes and Primary Care Research Networks (DRN and PCRN), general practices sent pre-assembled invitation packs to people with a diagnosis of diabetes. Invitation packs included a cover letter, screening questionnaire (with consent form), information leaflet, and a Freepost envelope. Eligible patients entered a 2-month, pre-randomisation, run-in phase on placebo tablets and were only randomised if they completed a randomisation form and remained willing and eligible at the end of the run-in. Follow-up is ongoing, using mail-based approaches that are being supplemented by central registry data. Information on approximately 600,000 people listed on 58 centrally held diabetes registers was obtained, and 300,188 potentially eligible patients were invited to join the study. In addition, 785 GP practices mailed invitations to 120,875 patients. A further 2,340 potential study participants were identified via other routes. In total, 423,403 people with diabetes were invited to take part; 26,462 entered the 2-month, pre-randomisation, run-in phase; and 15,480 were randomised. If sufficient numbers of potentially eligible patients can be identified centrally and the trial treatments do not require participants to attend clinics, the recruitment and follow-up of patients by mail is feasible and cost-effective. Wider use of these methods could allow more, large, randomised trials to be undertaken successfully and cost-effectively. Current Controlled Trials, ISRCTN60635500, registered on 14 July 2005 The online version of this article (doi:10.1186/s13063-016-1354-9) contains supplementary material, which is available to authorized users.