Chuchu Naomi, Takwoingi Yemisi, Dinnes Jacqueline, Matin Rubeta N, Bassett Oliver, Moreau Jacqueline F, Bayliss Susan E, Davenport Clare, Godfrey Kathie, O'Connell Susan, Jain Abhilash, Walter Fiona M, Deeks Jonathan J, Williams Hywel C
Institute of Applied Health Research, University of Birmingham, Birmingham, UK, B15 2TT.
Cochrane Database Syst Rev. 2018 Dec 4;12(12):CD013192. doi: 10.1002/14651858.CD013192.
Melanoma accounts for a small proportion of all skin cancer cases but is responsible for most skin cancer-related deaths. Early detection and treatment can improve survival. Smartphone applications are readily accessible and potentially offer an instant risk assessment of the likelihood of malignancy so that the right people seek further medical attention from a clinician for more detailed assessment of the lesion. There is, however, a risk that melanomas will be missed and treatment delayed if the application reassures the user that their lesion is low risk.
To assess the diagnostic accuracy of smartphone applications to rule out cutaneous invasive melanoma and atypical intraepidermal melanocytic variants in adults with concerns about suspicious skin lesions.
We undertook a comprehensive search of the following databases from inception to August 2016: Cochrane Central Register of Controlled Trials; MEDLINE; Embase; CINAHL; CPCI; Zetoc; Science Citation Index; US National Institutes of Health Ongoing Trials Register; NIHR Clinical Research Network Portfolio Database; and the World Health Organization International Clinical Trials Registry Platform. We studied reference lists and published systematic review articles.
Studies of any design evaluating smartphone applications intended for use by individuals in a community setting who have lesions that might be suspicious for melanoma or atypical intraepidermal melanocytic variants versus a reference standard of histological confirmation or clinical follow-up and expert opinion.
Two review authors independently extracted all data using a standardised data extraction and quality assessment form (based on QUADAS-2). Due to scarcity of data and poor quality of studies, we did not perform a meta-analysis for this review. For illustrative purposes, we plotted estimates of sensitivity and specificity on coupled forest plots for each application under consideration.
This review reports on two cohorts of lesions published in two studies. Both studies were at high risk of bias from selective participant recruitment and high rates of non-evaluable images. Concerns about applicability of findings were high due to inclusion only of lesions already selected for excision in a dermatology clinic setting, and image acquisition by clinicians rather than by smartphone app users.We report data for five mobile phone applications and 332 suspicious skin lesions with 86 melanomas across the two studies. Across the four artificial intelligence-based applications that classified lesion images (photographs) as melanomas (one application) or as high risk or 'problematic' lesions (three applications) using a pre-programmed algorithm, sensitivities ranged from 7% (95% CI 2% to 16%) to 73% (95% CI 52% to 88%) and specificities from 37% (95% CI 29% to 46%) to 94% (95% CI 87% to 97%). The single application using store-and-forward review of lesion images by a dermatologist had a sensitivity of 98% (95% CI 90% to 100%) and specificity of 30% (95% CI 22% to 40%).The number of test failures (lesion images analysed by the applications but classed as 'unevaluable' and excluded by the study authors) ranged from 3 to 31 (or 2% to 18% of lesions analysed). The store-and-forward application had one of the highest rates of test failure (15%). At least one melanoma was classed as unevaluable in three of the four application evaluations.
AUTHORS' CONCLUSIONS: Smartphone applications using artificial intelligence-based analysis have not yet demonstrated sufficient promise in terms of accuracy, and they are associated with a high likelihood of missing melanomas. Applications based on store-and-forward images could have a potential role in the timely presentation of people with potentially malignant lesions by facilitating active self-management health practices and early engagement of those with suspicious skin lesions; however, they may incur a significant increase in resource and workload. Given the paucity of evidence and low methodological quality of existing studies, it is not possible to draw any implications for practice. Nevertheless, this is a rapidly advancing field, and new and better applications with robust reporting of studies could change these conclusions substantially.
黑色素瘤在所有皮肤癌病例中占比小,但却是大多数皮肤癌相关死亡的原因。早期检测和治疗可提高生存率。智能手机应用程序易于获取,有可能对恶性病变的可能性进行即时风险评估,以便相关人员寻求临床医生的进一步医疗关注,对病变进行更详细的评估。然而,如果应用程序让用户放心其病变风险较低,就存在漏诊黑色素瘤和延误治疗的风险。
评估智能手机应用程序在排除有可疑皮肤病变的成年人皮肤侵袭性黑色素瘤和非典型表皮内黑素细胞病变方面的诊断准确性。
我们对以下数据库从创建到2016年8月进行了全面检索:Cochrane对照试验中央注册库;医学期刊数据库;荷兰医学文摘数据库;护理学与健康领域数据库;会议论文引文索引数据库;Zetoc数据库;科学引文索引;美国国立卫生研究院正在进行的试验注册库;英国国家卫生研究院临床研究网络组合数据库;以及世界卫生组织国际临床试验注册平台。我们研究了参考文献列表和已发表的系统评价文章。
评估智能手机应用程序的任何设计研究,这些应用程序供社区环境中的个人使用,他们有可能怀疑为黑色素瘤或非典型表皮内黑素细胞病变的病变,与组织学确认或临床随访及专家意见的参考标准进行对比。
两位综述作者使用标准化的数据提取和质量评估表(基于QUADAS-2)独立提取所有数据。由于数据稀缺和研究质量差,我们未对本综述进行荟萃分析。为了说明目的,我们在森林图上绘制了所考虑的每个应用程序的敏感性和特异性估计值。
本综述报告了两项研究中发表的两组病变。两项研究均因选择性招募参与者和不可评估图像的高比例而存在高偏倚风险。由于仅纳入了在皮肤科诊所环境中已选择切除的病变,以及由临床医生而非智能手机应用程序用户进行图像采集,对研究结果适用性的担忧很高。我们报告了两项研究中五个手机应用程序和332个可疑皮肤病变的数据,其中有86例黑色素瘤。在使用预编程算法将病变图像(照片)分类为黑色素瘤(一个应用程序)或高风险或“有问题”病变(三个应用程序)的四个基于人工智能的应用程序中,敏感性范围为7%(95%CI 2%至16%)至73%(95%CI 52%至88%),特异性范围为37%(95%CI 29%至46%)至94%(95%CI 87%至97%)。由皮肤科医生对病变图像进行存储转发审查的单个应用程序的敏感性为98%(95%CI 90%至100%),特异性为30%(95%CI 22%至40%)。测试失败的数量(应用程序分析但被研究作者归类为“不可评估”并排除的病变图像)范围为3至31(或分析病变的2%至18%)。存储转发应用程序的测试失败率最高(15%)。在四个应用程序评估中的三个中,至少有一例黑色素瘤被归类为不可评估。
基于人工智能分析的智能手机应用程序在准确性方面尚未显示出足够的前景,并且它们漏诊黑色素瘤的可能性很高。基于存储转发图像的应用程序通过促进积极的自我管理健康实践和使可疑皮肤病变患者尽早参与,可能在及时发现潜在恶性病变患者方面发挥潜在作用;然而,它们可能会大幅增加资源和工作量。鉴于现有研究证据匮乏且方法学质量低,无法得出对实践的任何启示。尽管如此,这是一个快速发展的领域,新的、更好的应用程序以及对研究的有力报告可能会大幅改变这些结论。