The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge CB2 0SR, UK.
BMJ. 2012 Jul 4;345:e4110. doi: 10.1136/bmj.e4110.
To assess whether adding a novel computerised diagnostic tool, the MoleMate system (SIAscopy with primary care scoring algorithm), to current best practice results in more appropriate referrals of suspicious pigmented lesions to secondary care, and to assess its impact on clinicians and patients.
Randomised controlled trial.
15 general practices in eastern England.
1297 adults with pigmented skin lesions not immediately diagnosed as benign.
Patients were assessed by trained primary care clinicians using best practice (clinical history, naked eye examination, seven point checklist) either alone (control group) or with the MoleMate system (intervention group).
Appropriateness of referral, defined as the proportion of referred lesions that were biopsied or monitored. Secondary outcomes related to the clinicians (diagnostic performance, confidence, learning effects) and patients (satisfaction, anxiety). Economic evaluation, diagnostic performance of the seven point checklist, and five year follow-up of melanoma incidence were also secondary outcomes and will be reported later.
1297 participants with 1580 lesions were randomised: 643 participants with 788 lesions to the intervention group and 654 participants with 792 lesions to the control group. The appropriateness of referral did not differ significantly between the intervention or control groups: 56.8% (130/229) v 64.5% (111/172); difference -8.1% (95% confidence interval -18.0% to 1.8%). The proportion of benign lesions appropriately managed in primary care did not differ (intervention 99.6% v control 99.2%, P=0.46), neither did the percentage agreement with an expert decision to biopsy or monitor (intervention 98.5% v control 95.7%, P=0.26). The percentage agreement with expert assessment that the lesion was benign was significantly lower with MoleMate (intervention 84.4% v control 90.6%, P<0.001), and a higher proportion of lesions were referred (intervention 29.8% v control 22.4%, P=0.001). Thirty six histologically confirmed melanomas were diagnosed: 18/18 were appropriately referred in the intervention group and 17/18 in the control group. Clinicians in both groups were confident, and there was no evidence of learning effects, and therefore contamination, between groups. Patients in the intervention group ranked their consultations higher for thoroughness and reassuring care, although anxiety scores were similar between the groups.
We found no evidence that the MoleMate system improved appropriateness of referral. The systematic application of best practice guidelines alone was more accurate than the MoleMate system, and both performed better than reports of current practice. Therefore the systematic application of best practice guidelines (including the seven point checklist) should be the paradigm for management of suspicious skin lesions in primary care.
Current Controlled Trials ISRCTN79932379.
评估新型计算机化诊断工具 MoleMate 系统（初级保健评分算法的 SIAscopy）是否会导致更多疑似色素性病变被转诊至二级保健，以及评估其对临床医生和患者的影响。
随机对照试验。
英格兰东部的 15 家普通诊所。
1297 名患有非立即诊断为良性的色素性皮肤病变的成年人。
经培训的初级保健临床医生使用最佳实践（临床病史、肉眼检查、七点检查表）单独（对照组）或结合 MoleMate 系统（干预组）对患者进行评估。
适当转诊，定义为活检或监测的转诊病变比例。与临床医生（诊断性能、信心、学习效果）和患者（满意度、焦虑）相关的次要结局。经济评估、七点检查表的诊断性能以及黑色素瘤发病率的五年随访也是次要结局，将在以后报告。
共有 1297 名参与者（1580 处病变）被随机分配：643 名参与者（788 处病变）分入干预组，654 名参与者（792 处病变）分入对照组。干预组和对照组的转诊适当性差异无统计学意义：56.8%（130/229）与 64.5%（111/172）；差异-8.1%（95%置信区间-18.0%至 1.8%）。在初级保健中适当管理良性病变的比例无差异（干预组 99.6%，对照组 99.2%，P=0.46），与专家决定活检或监测的百分比也无差异（干预组 98.5%，对照组 95.7%，P=0.26）。MoleMate 系统评估病变为良性的百分比显著较低（干预组 84.4%，对照组 90.6%，P<0.001），病变的转诊比例也更高（干预组 29.8%，对照组 22.4%，P=0.001）。诊断出 36 例组织学证实的黑色素瘤：18/18 例在干预组中被适当转诊，17/18 例在对照组中被适当转诊。两组临床医生均有信心，且未发现组间存在学习效应，因此也不存在污染。干预组的患者对其咨询的全面性和安心护理评价更高，尽管两组的焦虑评分相似。
我们没有发现 MoleMate 系统能提高转诊的适当性。最佳实践指南的系统应用比 MoleMate 系统更准确，两者的表现都优于当前实践报告。因此，最佳实践指南（包括七点检查表）的系统应用应该成为初级保健中管理可疑皮肤病变的范例。
当前对照试验 ISRCTN79932379。
Zotero 插件
