title: 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].
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: General Practice & Primary Care Research Unit, Department of Public Health & Primary Care, University of Cambridge, Cambridge, UK. fmw22@medschl.cam.ac.uk
authors.forename: Fiona M
authors.initials: FM
authors.lastname: Walter
authors.forename: Helen C
authors.initials: HC
authors.lastname: Morris
authors.forename: Elka
authors.initials: E
authors.lastname: Humphrys
authors.forename: Per N
authors.initials: PN
authors.lastname: Hall
authors.forename: Ann Louise
authors.initials: AL
authors.lastname: Kinmonth
authors.forename: A Toby
authors.initials: AT
authors.lastname: Prevost
authors.forename: Edward Cf
authors.initials: EC
authors.lastname: Wilson
authors.forename: Nigel
authors.initials: N
authors.lastname: Burrows
authors.forename: Paul
authors.initials: P
authors.lastname: Norris
authors.forename: Margaret
authors.initials: M
authors.lastname: Johnson
authors.forename: Jon
authors.initials: J
authors.lastname: Emery
mesh_terms: D000328:Adult; D000465:Algorithms; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009508:Nevus, Pigmented / Q000175:diagnosis* / Q000517:prevention & control; D018579:Patient Selection; D011237:Predictive Value of Tests; D011320:Primary Health Care / Q000379:methods*; D012017:Referral and Consultation; D012107:Research Design; D013053:Spectrophotometry; D006113:United Kingdom
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