Assessment of the implementation context in preparation for a clinical study of machine-learning algorithms to automate the classification of digital cervical images for cervical cancer screening in resource-constrained settings.
Assessment of the implementation context in preparation for a clinical study of machine-learning algorithms to automate the classification of digital cervical images for cervical cancer screening in resource-constrained settings.
复制标题
DOI：
10.3389/frhs.2022.1000150
复制
发表时间：
2022
期刊：
影响因子：
--
通讯作者：
Kuhn, Louise
中科院分区：
文献类型：
--
作者：
Castor, Delivette;Saidu, Rakiya;Boa, Rosalind;Mbatani, Nomonde;Mutsvangwa, Tinashe E M;Moodley, Jennifer;Denny, Lynette;Kuhn, Louise
我们评估了实施背景和图像质量，以准备一项临床研究，评估自动视觉评估设备在宫颈癌筛查中对无艾滋病毒和有艾滋病毒的妇女的有效性。我们开发了一个半结构化的问卷调查的基础上实施研究（CFIR）域的三个综合框架，干预的特点，内部设置，和过程中，在开普敦，南非。在2020年12月1日至2021年8月6日期间，我们评估了两种设备：MobileODT手持式阴道镜;和市售手机（三星A21 ST）。阴道镜医生目视检查宫颈图像的技术充分性。将定量变量的描述性分析制成表格，并在正文中总结叙述性回答。两名阴道镜医生描述这些设备操作简单，没有数据丢失。修改了临床工作空间和妇科工作流程，以纳入器械并管理图像。提供者认为，在大多数情况下，任何一种器械的性能都可能优于细胞学检查，除非鳞状柱状连接（SCJ）不可见，在这种情况下，细胞学检查预期更好。MobileODT设备和手机的图像质量（N = 75）在实现良好聚焦方面相当（81% vs. 84%），获得鳞状柱状连接的可见性（88% vs. 97%），避免闭塞（79%对87%），病变和病变范围的检测包括上限（63%对53%），但在无眩光拍摄照片时不同（100%对24%）。CFIR在临床研究早期的新应用，包括评估图像质量，突出可能影响临床研究结果和转化为临床实践的最终速度的干预特征、内部临床环境和工作流程的真实因素。CFIR在本研究背景下的应用和增强强调了框架所需的调整，以更好地衡量与实施数字干预相关的因素。
We assessed the implementation context and image quality in preparation for a clinical study evaluating the effectiveness of automated visual assessment devices within cervical cancer screening of women living without and with HIV. We developed a semi-structured questionnaire based on three Consolidated Framework for Implementation Research (CFIR) domains; intervention characteristics, inner setting, and process, in Cape Town, South Africa. Between December 1, 2020, and August 6, 2021, we evaluated two devices: MobileODT handheld colposcope; and a commercially-available cell phone (Samsung A21ST). Colposcopists visually inspected cervical images for technical adequacy. Descriptive analyses were tabulated for quantitative variables, and narrative responses were summarized in the text. Two colposcopists described the devices as easy to operate, without data loss. The clinical workspace and gynecological workflow were modified to incorporate devices and manage images. Providers believed either device would likely perform better than cytology under most circumstances unless the squamocolumnar junction (SCJ) were not visible, in which case cytology was expected to be better. Image quality (N = 75) from the MobileODT device and cell phone was comparable in terms of achieving good focus (81% vs. 84%), obtaining visibility of the squamous columnar junction (88% vs. 97%), avoiding occlusion (79% vs. 87%), and detection of lesion and range of lesion includes the upper limit (63% vs. 53%) but differed in taking photographs free of glare (100% vs. 24%). Novel application of the CFIR early in the conduct of the clinical study, including assessment of image quality, highlight real-world factors about intervention characteristics, inner clinical setting, and workflow process that may affect both the clinical study findings and ultimate pace of translating to clinical practice. The application and augmentation of the CFIR in this study context highlighted adaptations needed for the framework to better measure factors relevant to implementing digital interventions.