Data_Sheet_1_Patient perspectives of artificial intelligence as a medical device in a skin cancer pathway.docx

The use of artificial intelligence as a medical device (AIaMD) in healthcare systems is increasing rapidly. In dermatology, this has been accelerated in response to increasing skin cancer referral rates, workforce shortages and backlog generated by the COVID-19 pandemic. Evidence regarding patient perspectives of AIaMD is currently lacking in the literature. Patient acceptability is fundamental if this novel technology is to be effectively integrated into care pathways and patients must be confident that it is implemented safely, legally, and ethically. A prospective, single-center, single-arm, masked, non-inferiority, adaptive, group sequential design trial, recruited patients referred to a teledermatology cancer pathway. AIaMD assessment of dermoscopic images were compared with clinical or histological diagnosis, to assess performance (NCT04123678). Participants completed an online questionnaire to evaluate their views regarding use of AIaMD in the skin cancer pathway. Two hundred and sixty eight responses were received between February 2020 and August 2021. The majority of respondents were female (57.5%), ranged in age between 18 and 93 years old, Fitzpatrick type I-II skin (81.3%) and all 6 skin types were represented. Overall, there was a positive sentiment regarding potential use of AIaMD in skin cancer pathways. The majority of respondents felt confident in computers being used to help doctors diagnose and formulate management plans (median = 70; interquartile range (IQR) = 50–95) and as a support tool for general practitioners when assessing skin lesions (median = 85; IQR = 65–100). Respondents were comfortable having their photographs taken with a mobile phone device (median = 95; IQR = 70–100), which is similar to other studies assessing patient acceptability of teledermatology services. To the best of our knowledge, this is the first comprehensive study evaluating patient perspectives of AIaMD in skin cancer pathways in the UK. Patient involvement is essential for the development and implementation of new technologies. Continued end-user feedback will allow refinement of services to ensure patient acceptability. This study demonstrates patient acceptability of the use of AIaMD in both primary and secondary care settings.

人工智能医疗设备（Artificial Intelligence as a Medical Device，缩写为AIaMD）在医疗体系中的应用正快速增长。在皮肤病学领域，受COVID-19大流行导致的皮肤癌转诊率攀升、医护人员短缺以及诊疗积压等因素影响，该技术的应用得到了进一步加速。目前学界尚未有针对AIaMD患者视角的相关研究证据。若要将这项新兴技术有效融入临床诊疗路径，患者的接受度是核心前提；同时患者需确信该技术的应用符合安全、合法及伦理规范。本研究采用前瞻性、单中心、单臂、设盲、非劣效、适应性成组序贯设计的临床试验方案，招募了转诊至远程皮肤病学癌症诊疗路径的患者。通过将AIaMD对皮肤镜图像的评估结果与临床或组织病理学诊断结果进行对比，以评估其性能（临床试验注册号：NCT04123678）。受试者通过填写在线问卷，就AIaMD在皮肤癌诊疗路径中的应用发表了自身看法。2020年2月至2021年8月期间，研究共回收有效问卷268份。受访人群中女性占比57.5%，年龄跨度为18至93岁，81.3%的受试者为菲茨帕特里克I-II型皮肤（Fitzpatrick Skin Type），所有6种皮肤分型均有覆盖。整体而言，受试者对AIaMD在皮肤癌诊疗路径中的潜在应用持积极态度。多数受试者认可计算机辅助医生开展诊断并制定诊疗方案的作用（中位数为70，四分位距（Interquartile Range，简称IQR）为50-95），同时认可其作为全科医生评估皮肤皮损时的辅助工具（中位数为85，四分位距（Interquartile Range，简称IQR）为65-100）。受试者对使用手机拍摄皮损照片的接受度较高（中位数为95，四分位距（Interquartile Range，简称IQR）为70-100），这与其他评估远程皮肤病学服务患者接受度的研究结果一致。据我们所知，本研究是英国首个针对皮肤癌诊疗路径中AIaMD应用的患者视角展开的综合性研究。患者参与对于新技术的研发与落地至关重要。持续收集终端用户的反馈，可推动服务优化，进而保障患者接受度。本研究证实了患者对AIaMD在基层医疗与二级医疗场景中的应用均持有接受态度。