Effect of adding a diagnostic aid to best practice to manage suspicious pigmented lesions in primary care: randomised controlled trial

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Mole scanning device leads to over-referral

A mole scanning device does not improve the diagnosis of melanoma and results in more patients with benign lesions being referred for investigation and treatment, a GP study has found.



BMJ 2012; 345 doi: 10.1136/bmj.e4110 (Published 4 July 2012)


Objectives 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.


Design Randomised controlled trial.

Setting 15 general practices in eastern England.

Participants 1297 adults with pigmented skin lesions not immediately diagnosed as benign.

Interventions 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).

Main outcome measures 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.

Results 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% vcontrol 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.

Conclusions 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.




  1. #1 by Di Tron on July 6, 2012 - 5:50 am

    That’s a UK study. not applicable to Ozies’
    That said who needs silloscopy when the Drs I know biopsy anything that walks !
    nothing missing there !
    except the missing tax payers money

  2. #2 by Lishuang Chen on July 6, 2012 - 9:55 am

    Just thought that I share with you a scary case this week from one of the clinics I work at…
    A 35 year old lady had a “bening IDN excised” left chin .. but the path report back as nodular nevoid melanoma arising from a IDN . The whole lesion was apparenetly predominently polypoid IDN with a small clone of nevoid melanoma cells located centrally. It was already 1.3mm thick, level 4 ( just reaching reticular dermis). mitosos -2.

    This patient was seen in 2010 by another doctor at the same practice.. it was recorded as benign IDN left chin.

    Then she saw me in Feb 2012 and asked to have this mole removed. I wrote, ” benign IDN , monitor for any changes and r/v prn”

    Shen came back again last week and asked if she could have this removed as she thought it has been slowly growing over 10 years,although she had this mole for as long as she could remebmer.

    And guess what ? I didn’t even use dermoscopy to exam this lesion that day and agreed to removed it for “cosmetic reasons” . because the patient was not alarmed by any new changes except for slowly growing over years which is not an uncommon history that patient have when describing IDNs ! I wrote on the request form ” benign IDN, patient request removal ” !

    Now what am I supposed to do for those inocent looking IDNs which are supposed to be stable life long ? You know some patients have multiple polypoid IDNs who often present for removal for cosmetic reasons? The patients usually add sth like,” the mole has been growing over years and now more raised than before …?

    ….well……. tax payers money … NNT……

  3. #3 by Dr Ian McColl on July 7, 2012 - 10:49 am

    Lishuang, Ask for another opinion on the histology. Sometimes the unexpected happens! This is a difficult diagnosis histologically at the best of times.

    • #4 by Lishuang on July 12, 2012 - 9:31 am

      Thanks Ian, The pathologist who reported this case is my favourite pathologist who is trustworthy and thorough. She got another 5 collegues to review the slides before she reported the case. She also listed the names of those 5 pathologists ‘ names on the path report. The pathologist said that RPA usually would request slides from them if the patient was referred to RPA. This patients was referred to RPA last week. ….. I just hope the SLNB would be -ve .
      I will update you if the RPA disagree with the report.

  4. #5 by Irene on July 8, 2012 - 8:10 am

    Please note that the study was done in the UK by primary care GP’s who as a rule do not see many skin cancers & are not experienced in dermoscopy. They have used the Molscan device to triage the pigmented lesions and to make the diagnosis of melanoma. The machines are NOT designed to do this.
    I had a Solar Scan machine many years ago and the lesions registering the higher abnormality rates were the seb k’s. A coloured tattoo had the highest abnormality rating. I had to explain to the oatient that the machine was only used for digital monitoring. I don’t use this machine any more, using digital monitoring with an SLR camera + dermatoscope head attached.
    When it comes to epidemiiological studies on skin cancers, the country of origin of the study makes a big difference as the study results are often not applicable in Australia, especially in the context of the presence of trained skin cancer doctors.

  5. #6 by Graeme Siggs on July 9, 2012 - 6:18 am

    Not the first study to show that the SIAscope (= MoleMate) is hopeless.
    Just ask Jeff Keir about it.

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