Idnay Betina, Gordon Emily R, Johnson Aubrey S, Nestor Jordan G, Marder Karen, Weng Chunhua
Department of Biomedical Informatics, Columbia University, New York, NY, USA.
Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA.
J Clin Transl Sci. 2024 Oct 16;8(1):e167. doi: 10.1017/cts.2024.617. eCollection 2024.
Clinical research is critical for healthcare advancement, but participant recruitment remains challenging. Clinical research professionals (CRPs; e.g., clinical research coordinator, research assistant) perform eligibility prescreening, ensuring adherence to study criteria while upholding scientific and ethical standards. This study investigates the key information CRP prioritizes during eligibility prescreening, providing insights to optimize data standardization, and recruitment approaches.
We conducted a freelisting survey targeting 150 CRPs from diverse domains (i.e., neurological disorders, rare diseases, and other diseases) where they listed essential information they look for from medical records, participant/caregiver inquiries, and discussions with principal investigators to determine a potential participant's research eligibility. We calculated the salience scores of listed items using Anthropac, followed by a two-level analytic procedure to classify and thematically categorize the data.
The majority of participants were female (81%), identified as White (44%) and as non-Hispanic (64.5%). The first-level analysis universally emphasized age, medication list, and medical history across all domains. The second-level analysis illuminated domain-specific approaches in information retrieval: for instance, history of present illness was notably significant in neurological disorders during participant and principal investigator inquiries, while research participation was distinctly salient in potential participant inquiries within the rare disease domain.
This study unveils the intricacies of eligibility prescreening, with both universal and domain-specific methods observed. Variations in data use across domains suggest the need for tailored prescreening in clinical research. Incorporating these insights into CRP training and refining prescreening tools, combined with an ethical, participant-focused approach, can advance eligibility prescreening practices.
临床研究对医疗进步至关重要，但参与者招募仍然具有挑战性。临床研究专业人员（CRP；例如临床研究协调员、研究助理）进行资格预筛选，确保在坚持科学和道德标准的同时遵守研究标准。本研究调查了CRP在资格预筛选过程中优先考虑的关键信息，为优化数据标准化和招募方法提供见解。
我们针对来自不同领域（即神经系统疾病、罕见病和其他疾病）的150名CRP进行了自由列举调查，他们列出了从医疗记录、参与者/照顾者询问以及与主要研究者的讨论中寻找的基本信息，以确定潜在参与者的研究资格。我们使用Anthropac计算列出项目的显著度得分，然后进行两级分析程序对数据进行分类和主题归类。
大多数参与者为女性（81%），被认定为白人（44%）且非西班牙裔（64.5%）。一级分析普遍强调所有领域的年龄、用药清单和病史。二级分析揭示了信息检索中的特定领域方法：例如，在参与者和主要研究者询问期间，现病史在神经系统疾病中尤为重要，而在罕见病领域的潜在参与者询问中，研究参与情况则明显突出。
本研究揭示了资格预筛选的复杂性，观察到了通用方法和特定领域方法。各领域数据使用的差异表明临床研究需要量身定制的预筛选。将这些见解纳入CRP培训并完善预筛选工具，结合以参与者为中心的道德方法，可以推进资格预筛选实践。
