Mueller Jenna L, Asma Elizabeth, Lam Christopher T, Krieger Marlee S, Gallagher Jennifer E, Erkanli Alaattin, Hariprasad Roopa, Malliga J S, Muasher Lisa C, Mchome Bariki, Oneko Olola, Taylor Peyton, Venegas Gino, Wanyoro Anthony, Mehrotra Ravi, Schmitt John W, Ramanujam Nimmi
1Department of Biomedical Engineering, Duke University, Durham, NC; 2Duke Global Health Institute, Duke University, Durham, NC; 3Department of Surgery, Duke University Medical Center, Durham, NC; 4Department of Biostatistics and Bioinformatics, Duke University Medical School, Durham, NC; 5Institute of Cytology and Preventative Oncology (ICMR), New Delhi, India; 6Cancer Institute (WIA), Chennai, India; 7Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC; 8Kilimanjaro Christian Medical Centre, Moshi, Tanzania; 9Liga Contra el Cáncer, Pueblo Libre, Lima, Peru; and 10Department of Obstetrics and Gynecology, School of Medicine, Kenyatta University, Nairobi, Kenya.
J Low Genit Tract Dis. 2017 Apr;21(2):112-119. doi: 10.1097/LGT.0000000000000306.
Barriers to cervical cancer screening in low-resource settings include lack of accessible, high-quality services, high cost, and the need for multiple visits. To address these challenges, we developed a low-cost, intravaginal, optical cervical imaging device, the point-of-care tampon (POCkeT) colposcope and evaluated whether its performance is comparable with a standard-of-care colposcope.
There were 2 protocols, which included 44 and 18 patients. For the first protocol, white-light cervical images were collected in vivo, blinded by device, and sent electronically to 8 physicians from high-, middle-, and low-income countries. For the second protocol, green-light images were also collected and sent electronically to the highest performing physician from the first protocol who has experience in both a high- and low-income country. For each image, physicians completed a survey assessing cervix characteristics and severity of precancerous lesions. Corresponding pathology was obtained for all image pairs.
For the first protocol, average percent agreement between devices was 70% across all physicians. The POCkeT and standard-of-care colposcope images had 37% and 51% agreement with pathology for high-grade squamous intraepithelial lesions (HSILs), respectively. Investigation of HSIL POCkeT images revealed decreased visibility of vascularization and lack of contrast in lesion margins. After changes were made for the second protocol, the 2 devices achieved similar agreement to pathology for HSIL lesions (55%).
Based on the exploratory study, physician interpretation of cervix images acquired using a portable, low-cost POCkeT colposcope was comparable to a standard-of-care colposcope.
资源匮乏地区宫颈癌筛查的障碍包括缺乏可及的高质量服务、成本高昂以及需要多次就诊。为应对这些挑战，我们研发了一种低成本的阴道内光学宫颈成像设备——即时护理棉塞（POCkeT）阴道镜，并评估其性能是否与护理标准阴道镜相当。
有两个方案，分别纳入44例和18例患者。对于第一个方案，在体内采集白光宫颈图像，设备不显示信息，并通过电子方式发送给来自高、中、低收入国家的8名医生。对于第二个方案，还采集了绿光图像，并通过电子方式发送给第一个方案中表现最佳且在高、低收入国家均有经验的医生。对于每幅图像，医生完成一项调查，评估宫颈特征和癌前病变的严重程度。获取所有图像对对应的病理结果。
对于第一个方案，所有医生的设备间平均一致率为70%。POCkeT阴道镜和护理标准阴道镜图像对于高级别鳞状上皮内病变（HSIL）与病理结果的一致率分别为37%和51%。对HSIL的POCkeT图像进行研究发现，血管化可见度降低且病变边缘缺乏对比度。在对第二个方案进行调整后，两种设备对于HSIL病变与病理结果的一致率相似（55%）。
基于这项探索性研究,医生对使用便携式低成本POCkeT阴道镜获取的宫颈图像的解读与护理标准阴道镜相当。
