Lundström Erik, Isaksson Eva, Wester Per, Laska Ann-Charlotte, Näsman Per
Karolinska Institutet, Department of Clinical Neuroscience, Neurology, Karolinska University Hospital, Solna, 171 76, Stockholm, Sweden.
Karolinska Institutet, Department of Clinical Neuroscience, Neurology, Karolinska University Hospital, Building R3:04, Solna, 171 76, Stockholm, Sweden.
Trials. 2018 Jan 8;19(1):14. doi: 10.1186/s13063-017-2367-8.
Many randomised controlled trials (RCTs) fail to meet their recruitment goals in time. Trialists are advised to include study recruitment strategies within their trials. EFFECTS is a Swedish, academic-led RCT of fluoxetine for stroke recovery. The trial's primary objective is to investigate whether 20 mg fluoxetine daily compared with placebo for 6 months after an acute stroke improves the patient's functional outcome. The first patient was included on 20 October 2014 and, as of 31 August 2017, EFFECTS has included 810 of planned 1500 individuals. EFFECTS currently has 32 active centres. The primary objective of the ERUTECC (Enhancing Recruitment Using Teleconference and Commitment Contract) study is to investigate whether a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% at 60 days post intervention, compared with 60 days pre-intervention, in an ongoing RCT.
ERUTECC is a randomised, stepped-wedge cluster trial embedded in EFFECTS. The plan is to start ERUTECC with a running-in period of September 2017. The first intervention is due in October 2017, and the study will continue for 12 months. We are planning to intervene at all active centres in EFFECTS, except the five top recruiting centres (n = 27). The rationale for not intervening at the top recruiting centres is that we believe they have reached their full potential and the intervention would be too weak for them. The hypothesis of this study is that a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% 60 days post intervention, compared to 60 days pre-intervention, in an ongoing RCT.
EFFECTS is a large, pragmatic RCT of stroke in Sweden. Results from the embedded ERUTECC study could probably be generalised to high-income Western countries, and is relevant to trial management and could improve trial management in the future. It might also be useful in clinical settings outside the field of stroke.
The ERUTECC study was registered in the Northern Ireland Hub for Trials Methodology Research Studies Within a Trial repository ( SWAT58 ) on 30 April 2017. ClinicalTrials.gov, ID: NCT02683213 . Retrospectively registered on 2 February 2016.
许多随机对照试验（RCT）未能按时达成招募目标。建议试验者在试验中纳入研究招募策略。EFFECTS是一项由瑞典学术机构主导的关于氟西汀用于中风康复的随机对照试验。该试验的主要目的是研究急性中风后每天服用20毫克氟西汀与服用安慰剂6个月相比，是否能改善患者的功能结局。首例患者于2014年10月20日入组，截至2017年8月31日，EFFECTS已纳入计划招募的1500人中的810人。EFFECTS目前有32个活跃中心。ERUTECC（利用电话会议和承诺合同加强招募）研究的主要目的是调查，在一项正在进行的随机对照试验中，与干预前60天相比，在干预后60天，对各中心的研究人员进行一次结构化的电话会议回访，并附带一份承诺合同，是否能使招募人数增加20%。
ERUTECC是一项嵌入EFFECTS的随机、阶梯式楔形整群试验。计划于2017年9月的试运行期启动ERUTECC。首次干预定于2017年10月进行，研究将持续12个月。我们计划对EFFECTS中除五个招募人数最多的中心（n = 27）之外的所有活跃中心进行干预。不对招募人数最多的中心进行干预的理由是，我们认为它们已发挥出全部潜力，干预对它们来说力度太小。本研究的假设是，在一项正在进行的随机对照试验中，与干预前60天相比，在干预后60天，对各中心的研究人员进行一次结构化的电话会议回访，并附带一份承诺合同，能使招募人数增加20%。
EFFECTS是瑞典一项针对中风的大型实用随机对照试验。嵌入其中的ERUTECC研究的结果可能可推广至西方高收入国家，与试验管理相关，且可能在未来改善试验管理。它在中风领域之外的临床环境中可能也有用。
ERUTECC研究于2017年4月30日在北爱尔兰试验方法研究中心的试验存储库（SWAT58）中注册。ClinicalTrials.gov标识符：NCT02683213。于2016年2月2日进行追溯注册。
