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].
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.
Walter
Fiona M
FM
General Practice & Primary Care Research Unit, Department of Public Health & Primary Care, University of Cambridge, Cambridge, UK. fmw22@medschl.cam.ac.uk
Morris
Helen C
HC
Humphrys
Elka
E
Hall
Per N
PN
Kinmonth
Ann Louise
AL
Prevost
A Toby
AT
Wilson
Edward Cf
EC
Burrows
Nigel
N
Norris
Paul
P
Johnson
Margaret
M
Emery
Jon
J
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
Clin Exp Dermatol. 1991 Mar;16(2):151-3
1867692
BMC Dermatol. 2010 Sep 25;10:9
20868511
Br J Dermatol. 2004 Feb;150(2):179-85
14996086
J Gen Intern Med. 1998 Feb;13(2):91-7
9502368
Br J Dermatol. 2009 Dec;161(6):1270-7
19747359
Br J Cancer. 2007 Aug 20;97(4):486-93
17700548
BMJ. 2007 Mar 3;334(7591):455-9
17332585
J Am Acad Dermatol. 2003 Nov;49(5):777-97; quiz 798-9
14576657
J Med Screen. 1998;5(3):156-61
9795877
Ann R Coll Surg Engl. 2007 Sep;89(6):609-15
18201477
Inform Prim Care. 2008;16(1):41-50
18534076
Eur J Cancer. 2001 Oct;37 Suppl 8:S4-66
11602373
J Consult Clin Psychol. 1997 Jun;65(3):414-20
9170764
Arch Dermatol. 2003 Mar;139(3):282-8
12622618
Int J Dermatol. 2001 Feb;40(2):104-7
11328390
Melanoma Res. 2005 Dec;15(6):549-54
16314742
Br J Dermatol. 2004 Feb;150(2):291-8
14996100
CA Cancer J Clin. 1985 May-Jun;35(3):130-51
3921200
Br J Clin Psychol. 1992 Sep;31(3):301-6
1393159
J Cancer Educ. 2002 Spring;17(1):7-11
12000111
J Gen Intern Med. 2006 Jul;21(7):678-82
16808765
Br J Gen Pract. 2000 Nov;50(460):882-7
11141874
Br J Dermatol. 2002 Mar;146(3):448-57
11952545
BMJ. 2008 Oct 22;337:a1937
18945728
J Plast Reconstr Aesthet Surg. 2007;60(6):639-45
17485052
Br J Cancer. 2007 Jun 4;96(11):1772-7
17533392