KITE Research Institute, Toronto Rehab-University Health Network, Toronto, Ontario, Canada.
Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
J Spinal Cord Med. 2021;44(sup1):S240-S249. doi: 10.1080/10790268.2021.1970898.
Insufficient recruitment is a barrier to research and limits statistical power. We describe an initiative aimed to streamline recruitment and consent processes for inpatients with spinal cord injury or disease (SCI/D) via implementation of a Central Recruitment (CR) process. The CR process adhered to ethical standards, reduced participant burden, and maximized research participation.
In this CR process, the inpatient's nurse affirmed suitability for research approach based on fluency, cognition and health stability. A patient research liaison (PRL) was the sole contact for information regarding the research process, and introduced ongoing studies, screened for eligibility, and completed the consent process(es).
Over five and a half years, 1,561 inpatients with SCI/D were screened for eligibility upon admission, of whom 80% (1256/1561) were deemed suitable for the PRL approach. Of those suitable for the CR process, 80% (1001/1256) agreed to discuss current research opportunities, 46% (235/516) consented to participate in one or more studies, and 86% (856/1001) agreed to future research contact.
This process adhered to ethical procedures and reduced the burden of having multiple researchers approach each individual inpatient regarding research participation, with high consent rates for low-risk studies. Future evaluation of the process scalability is underway.
招募不足是研究的障碍，并限制了统计能力。我们描述了一项旨在通过实施中央招募（CR）流程来简化脊髓损伤或疾病（SCI/D）住院患者招募和同意过程的计划。该 CR 流程符合伦理标准，减轻了参与者的负担，并最大限度地提高了研究参与度。
在这个 CR 流程中，住院患者的护士根据语言流利程度、认知能力和健康稳定性来确认是否适合研究方法。患者研究联络人（PRL）是关于研究过程的唯一联系人，他会介绍正在进行的研究，筛选合格者，并完成同意过程。
在五年半的时间里，有 1561 名 SCI/D 住院患者在入院时接受了资格筛选，其中 80%（1256/1561）被认为适合 PRL 方法。在适合 CR 流程的患者中，80%（1001/1256）同意讨论当前的研究机会，46%（235/516）同意参与一项或多项研究，86%（856/1001）同意未来的研究联系。
该流程符合伦理程序，并减轻了多名研究人员向每位住院患者询问研究参与情况的负担，对于低风险研究，同意率很高。正在对该流程的可扩展性进行未来评估。
