Paulson Matthew L, Weng Chunhua
Department of Biomedical Informatics, Columbia University, New York, NY.
AMIA Annu Symp Proc. 2015 Nov 5;2015:2025-34. eCollection 2015.
Use of major eligibility criteria is a popular but unstudied folk practice for improving patient screening efficiency for clinical studies. This mixed-methods research study derived the desiderata for major eligibility criteria in breast cancer clinical trials. We randomly selected thirty interventional breast cancer clinical trials conducted at The New York-Presbyterian Hospital on the Columbia University Medical Center campus to create training (N=20) and testing (N=10) datasets. We utilized the Think-aloud protocol to gauge how clinical researchers identify and use major eligibility criteria to prescreen patients for clinical trials during an audio-recorded interview. A focus group session was held to understand the current prescreening process and investigate how it could be optimized to maximize recruitment rates. Using the grounded theory method, we annotated transcriptions to discover user rationale and desiderata behind major eligibility criteria in breast cancer clinical trials, which were later evaluated in a follow-up survey.
使用主要入选标准是一种流行但未经研究的民间做法，用于提高临床研究患者筛选效率。这项混合方法研究得出了乳腺癌临床试验主要入选标准的要求。我们从纽约长老会医院哥伦比亚大学医学中心校区进行的30项介入性乳腺癌临床试验中随机选取，创建了训练数据集（N = 20）和测试数据集（N = 10）。我们采用出声思维协议，通过录音访谈来衡量临床研究人员如何识别和使用主要入选标准对患者进行临床试验预筛选。举行了焦点小组会议，以了解当前的预筛选过程，并研究如何对其进行优化以最大化招募率。我们使用扎根理论方法对转录内容进行注释，以发现乳腺癌临床试验中主要入选标准背后的用户基本原理和要求，随后在后续调查中对其进行评估。
