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

BMJ 2012; 345 doi: https://doi.org/10.1136/bmj.e4110 (Published 04 July 2012) Cite this as: BMJ 2012;345:e4110
  1. Fiona M Walter, clinical lecturer in general practice19,
  2. Helen C Morris, trial coordinator1,
  3. Elka Humphrys, research assistant2,
  4. Per N Hall, consultant plastic surgeon3,
  5. A Toby Prevost, reader in medical statistics41,
  6. Nigel Burrows, consultant dermatologist3,
  7. Lucy Bradshaw, statistician5,
  8. Edward C F Wilson, lecturer in health economics6,
  9. Paul Norris, consultant dermatologist3,
  10. Joe Walls, plastic surgeon7,
  11. Margaret Johnson, lay member of trial steering committee8,
  12. Ann Louise Kinmonth, foundation professor of general practice1,
  13. Jon D Emery, Winthrop professor of general practice91
  1. 1The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge CB2 0SR, UK
  2. 2Cancer Research UK and UCL Cancer Trials Centre, London, UK
  3. 3Cambridge University Hospitals NHS Foundation Trust, Addenbrooke’s Hospital, Cambridge, UK
  4. 4Department of Primary Care and Public Health Sciences, King’s College London, London, UK
  5. 5Division of Epidemiology and Public Health, University of Nottingham, Nottingham, UK
  6. 6Health Economics Group, Faculty of Health, University of East Anglia, Norwich, UK
  7. 7Norfolk and Norwich University Hospital NHS Trust, Norwich, UK
  8. 8Cambridge
  9. 9School of Primary Aboriginal and Rural Health Care, University of Western Australia, Crawley, WA, Australia
  1. Correspondence to: F M Walter fmw22{at}medschl.cam.ac.uk
  • Accepted 8 May 2012

Abstract

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% v control 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.

Trial registration Current Controlled Trials ISRCTN79932379.

Footnotes

  • MoleMate, Astron Clinica, SIAscopy, SIAscan, and SIAscope were initially trademarks of Astron Clinica, which kindly supplied the MoleMate systems for this trial. In August 2009, Astron Clinica was taken over by Biocompatibles International, by BTG (British Technology Group) in January 2011, and by MedX Health in June 2011, which now holds these trademarks. We thank the independent chair of our trial steering committee, Neil Campbell; lay member Marion Edwards; David Mant for earlier comments on the design; and Jonathan Mant for comments on the revised paper. This research would not have been possible without the help of the participating patients, general practitioners, nurses, managers, and administrative staff of the general practices involved. We thank the lead clinicians for their commitment to the study: Stuti Mukherjee and Sally Kaemer, Cherry Hinton Medical Centre, Cambridge; Jenny Wheatley and Alan Mills, Comberton Surgery; Ian Marshman and Sarah Burling, Cornford House Surgery, Cambridge; Yvonne Girgis-Hanna and Christopher Clayton-Payne, Gold Street Surgery, Saffron Walden; Dr Karen Newman & Dr Kumar Nagadev, Huntingdon Road Surgery, Cambridge; Antony Warren and Clare Goodhart, Lensfield Medical Practice, Cambridge; Jo Farnell and Miguel Arbide, Linton Health Centre; Paul Linehan and Fiona Cornish, Newnham Walk Surgery, Cambridge; Robert Dobler Selma Malik, Nuffield Road Medical Centre, Cambridge; Paul Saban and Emma Ramsay, Rookery Medical Centre, Newmarket; Andrew Douglas and Baz Sanghera, St Mary’s Surgery, Ely; Sharon Woods and James Morrow, Sawston Medical Practice; John Tweedale and Jeremy Blakeborough, Shelford Medical Practice; Caroline Lea-Cox and Angus Stewart, Trumpington Street Medical Practice, Cambridge; and Alistair Brown and Judith Lindeck, York Street Medical Practice, Cambridge.

  • Contributors: FMW led the study and wrote the first draft of the report, supported by JDE. FMW, JDE, ALK, PNH, and ATP designed the study. HCM and EH oversaw the running of the study and the data collection. PNH, NB, PN, and JW provided clinical expertise. ATP, LB, and ECFW undertook the analyses. ATP and FMW take responsibility for the integrity of the data and the accuracy of the data analyses. All authors participated in execution and oversight of the study, interpretation of the data, critical review of drafts, and approved the final submitted version. FMW will act as guarantor and made the final decision to submit for publication. The sponsors of the study had no role in study design, data collection, data analysis, data interpretation, writing of the report, or in the decision to submit for publication. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.

  • Funding: This study was funded by the National Institute for Health Research (NIHR) School for Primary Care Research. The views expressed in this paper are those of the authors and not necessarily those of the Department of Health. ALK is an NIHR senior investigator. Service support costs were obtained from the Department of Health with the support of NHS Cambridgeshire and the East of England Primary Care Research Network.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work; JDE has received a research grant from Biocompatibles, PNH does consultancy for Lifescan & Health Screen UK: although PNH has longstanding intellectual involvement with the development of SIAscopy he has had no commercial involvement with Astron Clinica or Biocompatibles; no other relationships or activities that could appear to have influenced the submitted work.

  • Ethical approval: This study was approved by Cambridgeshire 2 research ethics committee (reference 07/H0308/167).

  • Data sharing: The statistical code and dataset are available from the corresponding author at fmw22{at}medschl.cam.ac.uk.

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