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首页> 外文期刊>BMC Family Practice >Protocol for the MoleMate? UK Trial: a randomised controlled trial of the MoleMate system in the management of pigmented skin lesions in primary care [ISRCTN 79932379]
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Protocol for the MoleMate? UK Trial: a randomised controlled trial of the MoleMate system in the management of pigmented skin lesions in primary care [ISRCTN 79932379]

机译：MoleMate的协议？英国试验：MoleMate系统在基层医疗中处理色素性皮肤病变的随机对照试验[ISRCTN 79932379]

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Background Suspicious pigmented lesions are a common presenting problem in general practice consultations; while the majority are benign a small minority are melanomas. Differentiating melanomas from other pigmented lesions in primary care is challenging: currently, 95% of all lesions referred to a UK specialist are benign. The MoleMate system is a new diagnostic aid, incorporating a hand-held SIAscopy scanner with a primary care diagnostic algorithm. This trial tests the hypothesis that adding the MoleMate system to current best primary care practice will increase the proportion of appropriate referrals of suspicious pigmented lesions to secondary care compared with current best practice alone. Methods/design The MoleMate UK Trial is a primary care based multi-centre randomised controlled trial, with randomisation at patient level using a validated block randomisation method for two age groups (45 years and under; 46 years and over). We aim to recruit adult patients seen in general practice with a pigmented skin lesion that cannot immediately be diagnosed as benign and the patient reassured. The trial has a 'two parallel groups' design, comparing 'best practice' with 'best practice' plus the MoleMate system in the intervention group. The primary outcome is the positive predictive value (PPV) of referral defined as the proportion of referred lesions seen by secondary care experts that are considered 'clinically significant' (i.e. biopsied or monitored). Secondary outcomes include: the sensitivity, specificity and negative predictive value (NPV) of the decision not to refer; clinical outcomes (melanoma thickness, 5 year melanoma incidence and mortality); clinician outcomes (Index of Suspicion, confidence, learning effects); patient outcomes (satisfaction, general and cancer-specific worry), and cost-utility. Discussion The MoleMate UK Trial tests a new technology designed to improve the management of suspicious pigmented lesions in primary care. If effective, the MoleMate system could reduce the burden on skin cancer clinics of patients with benign pigmented skin lesions, and improve patient care in general practice.
机译：背景可疑的色素沉着病变是普通诊治中常见的问题。多数为良性，少数为黑色素瘤。在基层医疗中将黑色素瘤与其他色素性病变区分开来具有挑战性：目前，转介给英国专家的所有病变中有95％是良性的。 MoleMate系统是一种新的诊断辅助工具，它结合了带有初级保健诊断算法的手持式SIAscopy扫描仪。该试验检验了这样一个假设：与当前的最佳实践相比，将MoleMate系统添加到当前的最佳初级护理实践中将增加可疑色素病变的适当转诊到二级护理的比例。方法/设计MoleMate UK试验是一项基于初级保健的多中心随机对照试验，采用有效的区组随机方法在两个年龄段（45岁及以下; 46岁及以上）的患者水平上进行随机分组。我们的目标是招募一般情况下见到的色素沉着的皮肤病灶，但不能立即被诊断为良性并且使患者放心的成年患者。该试验采用“两个平行小组”设计，将“最佳实践”与“最佳实践”以及干预组中的MoleMate系统进行了比较。主要结果是转诊的阳性预测值（PPV），定义为二级护理专家看到的被视为“临床上重要”（即活检或监测）的转诊病变比例。次要结果包括：不参考决定的敏感性，特异性和阴性预测值（NPV）;临床结果（黑色素瘤厚度，5年黑色素瘤发生率和死亡率）;临床结果（怀疑指数，自信心，学习效果）;患者的预后（满意度，一般性和特定于癌症的担忧）和成本效益。讨论MoleMate UK试验测试了一项旨在改善初级保健中可疑色素性病变管理的新技术。如果有效，MoleMate系统可以减轻皮肤良性色素病变患者皮肤癌诊所的负担，并在一般实践中改善患者护理。

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