title: Using the 7-point checklist as a diagnostic aid for pigmented skin lesions in general practice: a diagnostic validation study.
abstract: BACKGROUND
  GPs need to recognise significant pigmented skin lesions, given rising UK incidence rates for malignant melanoma. The 7-point checklist (7PCL) has been recommended by NICE (2005) for routine use in UK general practice to identify clinically significant lesions which require urgent referral.
  
  
  OBJECTIVE
  To validate the Original and Weighted versions of the 7PCL in the primary care setting.
  
  
  METHODS
  Diagnostic validation study, using data from a SIAscopic diagnostic aid randomised controlled trial in eastern England.
  
  
  METHODS
  Adults presenting in general practice with a pigmented skin lesion that could not be immediately diagnosed as benign were recruited into the trial. Reference standard diagnoses were histology or dermatology expert opinion; 7PCL scores were calculated blinded to the reference diagnosis. A case was defined as a clinically significant lesion for primary care referral to secondary care (total 1436 lesions: 225 cases, 1211 controls); or melanoma (36).
  
  
  RESULTS
  For diagnosing clinically significant lesions there was a difference between the performance of the Original and Weighted 7PCLs (respectively, area under curve: 0.66, 0.69, difference = 0.03, P<0.001). For the identification of melanoma, similar differences were found. Increasing the Weighted 7PCL's cut-off score from recommended 3 to 4 improved detection of clinically significant lesions in primary care: sensitivity 73.3%, specificity 57.1%, positive predictive value 24.1%, negative predictive value 92.0%, while maintaining high sensitivity of 91.7% and moderate specificity of 53.4% for melanoma.
  
  
  CONCLUSIONS
  The Original and Weighted 7PCLs both performed well in a primary care setting to identify clinically significant lesions as well as melanoma. The Weighted 7PCL, with a revised cut-off score of 4 from 3, performs slightly better and could be applied in general practice to support the recognition of clinically significant lesions and therefore the early identification of melanoma.
authors: Department of Public Health & Primary Care, Strangeways Research Laboratory, Cambridge. fmw22@medschl.cam.ac.uk
authors: Fiona M
authors: FM
authors: Walter
authors: A Toby
authors: AT
authors: Prevost
authors: Joana
authors: J
authors: Vasconcelos
authors: Per N
authors: PN
authors: Hall
authors: Nigel P
authors: NP
authors: Burrows
authors: Helen C
authors: HC
authors: Morris
authors: Ann Louise
authors: AL
authors: Kinmonth
authors: Jon D
authors: JD
authors: Emery
mesh_terms: D000328:Adult; D057189:Checklist; D004739:England / Q000453:epidemiology; D005260:Female; D058006:General Practice; D006801:Humans; D008297:Male; D008545:Melanoma / Q000175:diagnosis* / Q000453:epidemiology; D008875:Middle Aged; D010859:Pigmentation Disorders / Q000175:diagnosis* / Q000453:epidemiology; D011320:Primary Health Care; D012017:Referral and Consultation; D012680:Sensitivity and Specificity; D012878:Skin Neoplasms / Q000175:diagnosis* / Q000453:epidemiology
references: BMJ. 2012 Jul 04;345:e4110
references: 22763392
references: J Dermatol Surg Oncol. 1992 Jan;18(1):22-6
references: 1740563
references: Clin Exp Dermatol. 2012 Jan;37(1):6-9
references: 21981313
references: Postgrad Med J. 2000 May;76(895):295-8
references: 10775284
references: Arch Dermatol. 2003 Mar;139(3):282-8
references: 12622618
references: JAMA. 1999 Nov 10;282(18):1737-44
references: 10568646
references: Radiology. 1983 Sep;148(3):839-43
references: 6878708
references: Paediatr Perinat Epidemiol. 2009 Jul;23(4):380-92
references: 19523085
references: Br J Dermatol. 1994 Jan;130(1):48-50
references: 8305316
references: Clin Exp Dermatol. 1990 May;15(3):167-71
references: 2142028
references: Br J Dermatol. 1999 May;140(5):902-8
references: 10354030
references: Stat Med. 2006 Jul 15;25(13):2215-29
references: 16220470
references: Eur J Gen Pract. 2007;13(3):151-4
references: 17957586
references: BMJ. 1990 Nov 3;301(6759):1005-6
references: 2249043
references: BMJ. 2003 Jan 4;326(7379):41-4
references: 12511463
references: J Clin Oncol. 2009 Dec 20;27(36):6199-206
references: 19917835
references: Dermatology. 1998;197(1):11-7
references: 9693179
references: Melanoma Res. 2005 Dec;15(6):549-54
references: 16314742
references: CA Cancer J Clin. 1985 May-Jun;35(3):130-51
references: 3921200
references: JAMA. 2004 Dec 8;292(22):2771-6
references: 15585738
references: Arch Dermatol. 2008 Jan;144(1):58-64
references: 18209169