Bowns I R, Collins K, Walters S J, McDonagh A J G
School of Health and Related Research (ScHARR), University of Sheffield, UK.
Health Technol Assess. 2006 Nov;10(43):iii-iv, ix-xi, 1-39. doi: 10.3310/hta10430.
To compare the clinical equivalence, patient and clinician opinion of store-and-forward (SF) teledermatology with conventional face-to-face consultation in setting a management plan for new, adult outpatient referrals. To assess the equivalence of digital photography and dermoscopy with conventional face-to-face consultation in the management of suspected cases of malignant melanoma or squamous cell carcinoma.
For the SF teledermatology aspect of the study, a prospective randomised controlled trial was carried out.
Eight general practices and a hospital dermatology department in Sheffield, England.
For the SF teledermatology part of the study, adults (aged 16 years and over) requiring a new (not seen by a hospital dermatologist within the past year) consultant opinion. For the digital photography element of the study, adults (aged 16 years and over) requiring a consultant opinion due to suspicion of malignant melanoma or squamous cell carcinoma.
Patients in the telemedicine intervention group were referred to the consultant, and managed as far as possible using one or more digital still images and a structured, electronic referral and reply. The control group was managed by conventional hospital outpatient consultation. Patients referred to the 2-week wait clinic were invited to have a series of digital photographs, with and without dermoscopy, immediately before their face-to-face consultation. A second consultant viewed these and outlined a diagnosis and management plan which was compared with the actual management. Both were compared with the definitive diagnosis (either the final clinical or histological diagnosis, where undertaken).
The concordance between the consultant who had managed the case and an independent consultant who gave a second face-to-face opinion.
A total of 208 patients were recruited. There was also a greater loss of control cases (26%) than intervention cases (17%). A statistically significant difference in ages between the two groups completing the study (mean age of intervention group 43.6 years, control group 49.7 years, p = 0.039) indicates that this may have introduced a bias between the two groups. A further possible source of bias is the delay (mean difference of 54 days, p = 0.0001) between the SF opinion and the second opinion in the SF group, whereas control patients usually received their second opinion on the same day as their outpatient appointment. In 55% (51/92) of telemedicine cases and 78% (57/73) of control cases, the diagnosis concurred, with the second opinion. In 55% (51/92) of telemedicine cases and 84% (61/73) of control cases, the management plan concurred with the second opinion. Of the 92 telemedicine cases, 53 were judged also to require a face-to-face consultation, mainly to establish a diagnosis and treatment plan. With the digital photography for suspected skin cancer aspect of the study, it was found that an unexpectedly high proportion (33%, 85/256) of referrals proved to have a malignancy or a severely dysplastic lesion, with almost 22% having a malignant melanoma or squamous cell carcinoma, possibly reflecting the rise in incidence of skin cancers reported elsewhere. When both standard and dermoscopic images were employed, diagnostic concordance was modest (68%). The approach was highly sensitive (98%, 95% CI: 92 to 99%), at the expense of specificity (43%, 95% CI: 36 to 51%). Overall, 30% of cases would not have needed to be seen face-to-face, though two squamous cell carcinomas would have been missed (a number-needed-to-harm of 153). If the highest level of clinician confidence had been applied, no cancers would have been missed, but only 20% of patients would have avoided an outpatient appointment.
In view of the difficulties in recruitment and the potential biases introduced by selective loss of patients and the delay in obtaining a valid second opinion in the study group, no valid conclusions can be drawn regarding the clinical performance of this model of SF telemedicine. With regard to digital photography in suspected skin cancer, it is unlikely that this approach can dramatically reduce the need for conventional clinical consultations, whilst still maintaining clinical safety. Additional research on the assessment of diagnostic and management agreement between clinicians would be valuable in this and other fields of research.
比较存储转发（SF）远程皮肤病学与传统面对面会诊在为新的成年门诊转诊患者制定管理计划方面的临床等效性、患者及临床医生的意见。评估数字摄影和皮肤镜检查与传统面对面会诊在疑似恶性黑色素瘤或鳞状细胞癌病例管理中的等效性。
对于研究的SF远程皮肤病学部分，开展了一项前瞻性随机对照试验。
英国谢菲尔德的8家全科诊所和一家医院皮肤科。
对于研究的SF远程皮肤病学部分，为需要新的（过去一年未见过医院皮肤科医生）会诊意见的成年人（16岁及以上）。对于研究的数字摄影部分，为因疑似恶性黑色素瘤或鳞状细胞癌而需要会诊意见的成年人（16岁及以上）。
远程医疗干预组的患者被转介给会诊医生，并尽可能使用一张或多张数字静态图像以及结构化的电子转诊和回复进行管理。对照组通过传统的医院门诊会诊进行管理。被转介到两周等待诊所的患者在面对面会诊前被邀请拍摄一系列有皮肤镜和无皮肤镜的数字照片。另一位会诊医生查看这些照片并概述诊断和管理计划，将其与实际管理情况进行比较。两者均与最终诊断（最终临床诊断或组织学诊断，如有进行）进行比较。
负责该病例的会诊医生与给出第二次面对面意见的独立会诊医生之间的一致性。
共招募了208名患者。对照组的失访率（26%）也高于干预组（17%）。完成研究的两组患者年龄存在统计学显著差异（干预组平均年龄43.6岁，对照组49.7岁，p = 0.039），这表明这可能在两组之间引入了偏差。另一个可能的偏差来源是SF组中SF意见与第二次意见之间的延迟（平均差异54天，p = 0.0001）,而对照组患者通常在门诊预约当天接受第二次意见。在55%（51/92）的远程医疗病例和78%（57/73）的对照病例中，诊断与第二次意见一致。在55%（51/92）的远程医疗病例和84%（61/73）的对照病例中，管理计划与第二次意见一致。在92例远程医疗病例中，53例也被判定需要面对面会诊，主要是为了确定诊断和治疗计划。对于研究中疑似皮肤癌的数字摄影方面，发现转诊病例中意外有高比例（33%，85/256）被证明患有恶性肿瘤或严重发育异常病变，近22%患有恶性黑色素瘤或鳞状细胞癌，这可能反映了其他地方报道的皮肤癌发病率上升。当同时使用标准图像和皮肤镜图像时，诊断一致性一般（68%）。该方法具有高度敏感性（98%，95%CI：92至99%），但特异性较低（43%，95%CI：36至51%）。总体而言，30%的病例无需面对面就诊，不过会漏诊两例鳞状细胞癌（伤害需治人数为153）。如果采用临床医生最高置信水平，不会漏诊任何癌症，但只有20%的患者可以避免门诊预约。
鉴于招募困难以及研究组中患者选择性失访和获得有效第二次意见的延迟所引入的潜在偏差，无法就这种SF远程医疗模式的临床性能得出有效结论。关于疑似皮肤癌的数字摄影，这种方法不太可能大幅减少传统临床会诊的需求，同时仍能维持临床安全性。在这一领域及其他研究领域，对临床医生之间诊断和管理一致性评估的进一步研究将很有价值。
