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1 =C 0= C8E4 <4;0=><0 3806=>B8B Wednesday 20 th November 2002 Centenary Institute of Cancer Medicine & Cell Biology Royal Prince Alfred Hospital Missenden Road Camperdown NSW WORKSHOP SUMMARY

2 =C 0= C8E4 <4;0=><0 3806=>B8B A report of the workshop held at the Centenary Institute of Cancer Medicine and Cell Biology Royal Prince Alfred Hospital Missenden Road Camperdown NSW on 20 November 2002

3 Efficient and Effective Melanoma Diagnosis A SUMMARY OF THE WORKSHOP HELD IN SYDNEY ON NOVEMBER 20, 2002 National Cancer Control Initiative 1 Rathdowne St Carlton Vic 3053 Australia Tel: +61 (0) Fax: +61 (0) enquiries@ncci.org.au Internet: Published April 2003 ISBN National Cancer Control Initiative Suggested citation: National Cancer Control Initiative 2003: Efficient and effective melanoma diagnosis. National Cancer Control Initiative, Melbourne, 1-38 This document is also available at

4 2>=C4=CB INTRODUCTION... 7 SESSION 1: WHAT S THE PROBLEM - WHAT S HAPPENED SO FAR: RESULTS OF TRIALS AND INTERVENTIONS... 9 Introduction & Aims Professor Robert Burton... 9 The Del Mar and Green intervention Professor Chris Del Mar... 9 The Perth skin cancer trial Dr Dallas English Melanoma diagnosis and skin screening in Queensland Dr Joanne Aitken SESSION ONE DISCUSSION Specialist skin cancer clinics e.g., MoleMax Photography and camera use Thickness and delay in presentation Who diagnoses melanoma Benign to malignant ratio Comment by Dr Richard Scolyer SESSION 2: WHAT OTHER APPROACHES CAN WE USE? Dermoscopy Dr Scott Menzies Total body photography I: The early detection of melanoma in high risk subjects using baseline imaging Associate Professor John Kelly Total body photography II: A randomised trial of photography as an aid to management of skin lesions in older males Dr Pauline Hanrahan Digital monitoring Dr Scott Menzies SESSION TWO DISCUSSION Dermoscopy Total body photography Digital monitoring SESSION THREE: WHERE TO NEXT- FUTURE TECHNOLOGIES, HOW CAN WE PROCEED? Technologies in the future Dr Scott Menzies Assessing the diagnostic accuracy of tests Professor Les Irwig What is required for a Medicare rebate? Mr Mike McKenzie Medico-legal problems with melanoma patients Professor Gerry Milton SESSION THREE DISCUSSION Future technologies CONTENTS CONTENTS 3

5 Test accuracy Medicare rebate Medico-legal issues FINAL DISCUSSION How do we proceed? Consumer Comment Final conclusions REFERENCES LIST OF PARTICIPANTS NATIONAL CANCER CONTROL INITIATIVE 4 EFFICIENT AND EFFECTIVE MELANOMA DIAGNOSIS

6 About the NCCI and the Sydney Melanoma Diagnostic Centre ORGANISATIONS The NCCI is a partnership between The Cancer Council Australia and the Commonwealth Department of Health and Ageing. The role of the NCCI is to provide timely and expert advice on all issues related to cancer control as well as manage a range of projects in cancer control. The Initiative works closely with other bodies including The Cancer Council Australia, State and Territory governments and non-government organizations. The NCCI s activities take account of the National Health Priorities of the Commonwealth Government and require evidencebased practice and systematic reviews of the literature on the various aspects of cancer control. Further information about the NCCI and its projects can be found on its website at MASCRI is a joint development of the Melanoma Foundation and the Dermatology Research Foundation at the University of Sydney. It is the research arm of the Sydney Melanoma Unit, the Sydney Melanoma Diagnostic Centre and the Belisario Institute of Dermatology at the Royal Prince Alfred Hospital in Sydney. Clinical trials and new therapies, development of new diagnostic methods, behavioural research and basic research in genetics, immunobiology and ultraviolet carcinogenesis are the main areas of MASCRI activities. The Sydney Melanoma Diagnostic Centre is a clinical unit of MASCRI. The centre s aims are to apply best practice methods for the diagnosis and management of skin tumours, with a particular emphasis on pigmented lesions (eg. moles and melanoma) and to conduct research on diagnostic and therapeutic techniques for skin tumours. Further information about the centre can be found at ORGANISATIONS 5

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8 =C 0= C8E4 <4;0=><0 3806=>B8B A workshop to discuss Efficient and effective melanoma diagnosis was held on 20 November 2002 at the Centenary Institute of Cancer Medicine and Cell Biology Royal Prince Alfred Hospital in Camperdown, NSW. It was jointly convened by the National Cancer Control Initiative (NCCI) and Dr Scott Menzies of the Sydney Melanoma Diagnostic Centre. INTRODUCTION Objective The objective of the workshop was to review past and ongoing research on the diagnosis of melanoma and to seek consensus for future studies aimed at improving the efficiency of melanoma diagnosis in the primary care setting. The workshop was divided into three sessions: Session One: What s the problem? What s happened so far: Results of trials and interventions. Chair Professor Robert Burton Session Two: What other approaches can we use? Chair - Professor Robin Marks Session 3: Where to next? Future technologies, how can we proceed? Chair Professor Mark Elwood The first session covered studies of diagnostic interventions that have been assessed in primary care. The second included approaches that have been assessed in expert settings and could be suitable for testing in general practice. The final session presented information about developments in technology that are not yet suitable for widespread use and examined issues needing consideration when designing a study for assessing a diagnostic intervention. Audience discussions followed each topic and the final discussion focussed on achieving consensus for a study in general practice. Attendance The workshop was open to all interested participants. Forty-six people attended including dermatologists, general practitioners, Commonwealth government representatives, consumers, INTRODUCTION 7

9 epidemiologists and public health professionals involved in skin cancer awareness campaigns. The full participant list is given in the Appendix. Workshop Summary This summary contains a brief synopsis of each presentation and a summary of the points raised during the discussion that followed. Abstracts for each of the presentations were included in the Program and Proceedings for the workshop, copies of which are available on request. 8 EFFICIENT AND EFFECTIVE MELANOMA DIAGNOSIS

10 B4BB8>= %. F70CPB C74?A>1;4< " F70CPB 70??4=43 B> 50A. A4BD;CB >5 CA80;B 0=3 8=C4AE4=C8>=B Introduction & Aims SESSION ONE Professor Robert Burton Honorary Senior Advisor, NCCI and Chair, Cancer Strategies Group Summary: Australia is the only country in the world where the age standardised mortality rate for melanoma has declined in both males and females. At the same time, the age-standardised incidence rate has increased. There are around 8,000 new melanoma cases identified annually in Australia and around 1000 melanoma deaths [Australian Institute of Health and Welfare and Australasian Association of Cancer Registries, 2002] suggesting that almost 90% of those diagnosed are cured. Associated with the increased incidence have been increases in the cost to the health care system of excising skin lesions. In 1985 approximately 2% of Australians had at least one skin lesion removed and by 1995 this proportion had risen to almost 5%. We appear to be effective in diagnosing melanoma but there are questions about how efficient we are. Diagnostic efficiency can be measured in terms of the benign to malignant ratio of lesions removed. For non-pigmented lesions, this ratio was around 0.8:1 in 1995 while for pigmented lesions it was closer to 25:1. In Australia, approximately 60% of lesions are removed by general practitioners and a number of studies have indicated that the benign to malignant ratio in the primary care setting is around 30:1. A reduction in the ratio would indicate improved diagnostic efficiency and could help to contain excision costs. The Del Mar and Green intervention Professor Chris Del Mar Director, Centre for General Practice, University of Queensland Medical School Background and objectives: The average full-time general practitioner (GP) servicing about 1000 patients sees 1-2 melanomas per year and a death from melanoma every 5-6 years. SESSION ONE 9

11 Often skin cancer management is not the primary reason for a consultation with a GP and over 50% of skin cancers are managed in conjunction with other conditions. The best predictor of melanoma in an individual is a large number of either benign or dysplastic naevi and a major problem for clinicians is to differentiate the benign lesions from those that are malignant, thus, it is difficult to exclude melanoma in those most at risk. An analysis of Australian GP consultations showed that naevi and moles were more likely to be managed in younger patients, particularly females, despite older people being at greater risk. Some diagnostic assistance is available in the form of guides about the size, shape, colour and changeability of suspicious lesions but, even with these, doctors tend to err on the side of caution excising many benign lesions for each malignant one. To test whether an algorithm and an instant camera could assist in differentiating benign and malignant lesions, a randomised controlled trial was conducted in two cities in northern Queensland [Del Mar and Green, 1995]. Methods: Each city had about 50 GPs and a population of around 100,000 people. GPs in the intervention city were given a copy of the algorithm and an instant camera that could provide a life size colour image. When the lesion was re-examined 4 to 8 weeks later, it could be compared with the photograph to determine whether a change had occurred. Most lesions showing a change over time are likely to be melanoma and current advice is to remove such lesions. Data on excision rates of benign and malignant melanocytic lesions during the two years of the intervention were compared with excision rates for the six months prior to the trial to determine the effect of the intervention. Results: Both cities had similar excision rates prior to the intervention. Following the intervention, the proportion of excised lesions that were not invasive was similar in both cities but amongst these non-invasive lesions, the proportion that could be considered potentially invasive was higher in the intervention group. The proportion of lesions removed from young people and women decreased in the intervention city. The doctors themselves perceived no changes in their excision rates. A major concern was that in reducing the number of excisions, melanoma diagnoses may be missed but there was no evidence of this as melanoma diagnoses were similar in both cities before the intervention and during the follow-up period. The benign to malignant ratio varied by body site of the lesion and was lower for the limbs than for the head and neck. The most common reason for excision was to exclude malignancy but, in over 10% of cases, doctors excised the lesion solely because of perceived pressure from the patient. The number needed to excise for each case diagnosed was used as an outcome measure in preference to benign to malignant ratio and this was lower in the intervention group. Conclusion: The intervention lowered the rate of unnecessary excisions and may reassure the patient that a well-defined strategy has been adopted to deal with their lesion. 10 EFFICIENT AND EFFECTIVE MELANOMA DIAGNOSIS

12 The Perth skin cancer trial Dr Dallas English Associate Director, Cancer Epidemiology Centre, The Cancer Council Victoria Background and Objective: This study was established to determine whether the results of the Del Mar and Green intervention could be replicated in urban general practice. Methods: Using a group randomised design with practices stratified by number of GPs, general practices in Perth were randomised to receive either training in the algorithm and use of an instant camera or no intervention. The overall response rate was 38% with 111 practices randomised to the intervention group and 112 to the control group. Pathology reports for pigmented lesions excised by the participating GPs were obtained for the twelve months prior to, and ten months following, randomisation. The primary outcome measure was the ratio of benign pigmented skin lesions to malignant melanomas excised by the GPs. SESSION ONE Results: Around 20% of GPs in the control group and 30% in the intervention group did not excise any lesions in the baseline period 12 months prior to the trial. In this period, the benign to malignant ratio was higher in the control group than the intervention group (32:1 compared with 26:1). In the 10 months following the intervention, the benign to malignant ratio in the control group decreased to 26:1 but in the intervention group it increased to 29:1. Excision rates in the intervention group were higher than the control group for both benign lesions and melanoma but the differences were not significant. For the intervention group, there was no change in the benign excision rate for patients aged 40 years and over but there was a substantial decrease in the under 40 age group. The intervention may have reduced the number of skin excisions in the younger patients, but it resulted in almost no change in the older patients. Conclusion: Overall, the intervention did not decrease the benign to malignant ratio but raises concerns about a decrease in sensitivity for melanoma. Melanoma diagnosis and skin screening in Queensland Dr Joanne Aitken Queensland Cancer Registry, Queensland Cancer Fund Background: This Queensland project is being conducted to determine whether screening improves the diagnosis of early invasive melanoma, and whether screening results in over diagnosis of non-invasive lesions. Interim data are available from the first two and a half years of the study about how melanoma is diagnosed, who diagnoses it and the relationship between delay in diagnosis and thickness of the lesion. SESSION ONE 11

13 Methods: This is a population-based case-control study of all melanoma cases aged 20 to 75 years notified to the Queensland Cancer Registry during the period 2000 to 2003 inclusive. Controls were randomly selected from the Electoral Roll and matched to the cases by age and sex. Interim Results: 2447 cases (79% of those eligible) and 2028 controls (55% of those eligible) agreed to be interviewed by computer-assisted telephone interview (CATI). To assist with recall of events and dates, a copy of the questions was posted to participants prior the interview. Skin screening among controls: Twenty percent of controls had had one or more deliberate whole-body skin checks, done either by themselves or another lay person, in the previous three years. Rates of screening by lay persons were higher for men and people aged under 50 years. Twenty-seven percent had had a deliberate skin check by a doctor in the last three years compared with 20% in For doctor initiated screening, there were no sex differences overall but there was a higher screening rate in men aged over 50 years. The increases in skin screening are affecting how melanoma is detected and patient pressure for excision is influencing the benign to malignant ratio. How is melanoma discovered: Almost 90% of lay detected melanomas were found accidentally when someone noticed a suspicious lesion rather than by a deliberate body check. A change in size or colour of the lesion were the most commonly reported signs and symptoms of thin ( 0.75mm) lesions. A lumpy or raised texture was also commonly reported for thick (> 0.75mm) lesions. For doctor detected lesions, around 70% were found during a body check done mainly at the request of the patient and melanomas detected by doctors were generally thinner than those found by the patient. Who discovers melanoma: At least 75% of melanomas were first discovered by the patient or another lay person. For doctor detected melanomas, about 60% were found by GPs, 20% by dermatologists or other specialists and 15% by skin clinics such as MoleMax. Neither the total number of excisions nor the benign to malignant ratio for these clinics is known but the proportion of melanomas found through skin clinics was disproportional to the number of clinics in the state. Time to diagnosis: Men and younger people took longer to present with their suspicious lesions. Delay in presentation was not related to thickness of the tumour at diagnosis but nodular melanomas and thick lesions tended to be presented sooner. The average time between first presentation to a doctor and definitive diagnosis was about four months. Diagnosis of patient identified lesions took twice as long as doctor detected lesions. Rapidly growing invasive melanomas were diagnosed soonest and lesions on women and, counter-intuitively, lesions on visible body sites took significantly longer to be diagnosed. There was no apparent difference in the time from first noticing a lesion to definitive diagnosis either by histological type or thickness. 12 EFFICIENT AND EFFECTIVE MELANOMA DIAGNOSIS

14 B4BB8>= >=4 38B2DBB8>= The questions and discussion covered a number of issues raised in the presentations and are summarised under the headings below. Specialist skin cancer clinics e.g., MoleMax Results from Dr Joanne Aitken s study suggest that specialist primary care skin cancer clinics diagnose a disproportionately high number of melanomas. South east Queensland and some regional areas have a high concentration of these clinics which may partly explain these findings. Some anecdotal information was offered which indicated that skin clinics are playing an increasingly important role in skin lesion management and this is changing the way melanoma is diagnosed. DISCUSSION ONE In support of this view, one dermatologist who conducted a skin cancer clinic in a rural town and saw virtually all melanoma diagnosed in the town, reported that around 90% of the melanomas he saw were now referred from a MoleMax clinic. Very few were referred by the local GPs and it appeared that people were attending skin clinics for management of their skin lesions. Several GPs in the audience had moved from general practice to specialist skin clinics. They highlighted differences in their experiences of consultations for skin lesions between the two settings. In a typical general practice, patients often raised concerns about a lesion at the end of a consultation for another problem when there was little or no time available. They were reluctant to return for a total body examination in a dedicated consultation or for follow-up of a lesion. Patients were more willing to attend primary care skin clinics for consultations specifically involving skin lesions and were more inclined to attend for the recommended followup several months later. A large proportion of melanomas are now diagnosed through skin cancer clinics. To fully understand the role these clinics play, further information is needed on who attends the clinics, the number of consultations, the benign to malignant excision ratio, the breakdown of diagnoses and the use of photography or other forms of imaging. A suggestion from the audience was made regarding the benefit of a study comparing skin cancer clinics with usual general practice. Photography and camera use Both the Del Mar and Green study and the Perth Trial were based on photographing a single suspicious lesion and monitoring it for change. It might be preferable to photograph a field of lesions containing the suspicious one and to monitor change relative to the other lesions in the field. Focusing on one lesion for photography may also mean missing changes in other lesions. There was also concern that the follow-up time of 4-8 weeks used in the Perth Trial was too short to detect a change in slow growing lesions and that six months might have been a more suitable time frame. Unfortunately, information about the proportion of melanomas excised that DISCUSSION ONE 13

15 had changed during the study period was not collected and could not be obtained from the pathology reports or request forms. Thickness and delay in presentation Information on the growth dynamics of melanoma may help explain patient delay in presentation. Thick lesions are usually fast growing and, because they change rapidly, patients with these lesions may be more likely to present sooner. Thin slow growing lesions may raise concerns more slowly and result in longer presentation times. A hot pursuit type study in which patients were interviewed after their biopsy but before receiving the pathology results could address questions about how the lesion was found, what prompted the patients to seek medical attention and how long they waited before seeking attention. Who diagnoses melanoma Several of the doctors who worked in dedicated skin clinics reported seeing about one melanoma per month. They said that between 50% and 70% of the diagnoses were made as a result of patient concern about a particular lesion while the remainder were made by the doctor after a full-body check following a consultation for BCC or SCC. A large number of melanomas were detected accidentally by patients, that is, they were not found by a deliberate examination of the skin. The importance of listening to patient concerns and understanding what prompted them to seek medical attention was stressed. Patients may present later with slow growing lesions on visible body sites as they can monitor these easily themselves. Attention may be sought more quickly for fast growing lesions or lesions on sites that were difficult to see. Benign to malignant ratio The prevalence of naevi remains relatively constant with age but melanoma prevalence increases thus decreasing the ratio of benign to malignant lesions. Whole body photography may be more useful in older age groups in whom melanoma is more likely. There was discussion about the value of the benign to malignant ratio as a measure of competency. Most GPs see around one melanoma per year and even fewer melanoma deaths. Each melanoma occurs against a vast background of benign lesions and we may be expecting too much of GPs by asking them to lower their benign to malignant ratio. The major problem with the ratio is its dependence on the prevalence of malignant lesions in the population. GPs see unselected patients whereas dermatologists and plastic surgeons see referred patients with a higher prevalence of melanoma. Even with the same diagnostic skills, the benign to malignant ratio will be greater in a primary care setting than in referred patients. 14 EFFICIENT AND EFFECTIVE MELANOMA DIAGNOSIS

16 Any measure of competency is subjective. In an Australian study [Ward and Boyle, 1994], some GPs thought their ratio should be closer to 1:1 or 2:1. A study in northern England [personal communication] found the benign to malignant ratio in skin clinics ranged from 25:1 to 50:1 but this could be partly explained by the lower prevalence of melanoma in England. Comment by Dr Richard Scolyer Dermatopathologist The use of shave or punch biopsies for suspected melanocytic lesions should be discouraged. This is because histopathological diagnosis requires assessment of a range of architectural and cytological features including features at the deep and peripheral edges of the lesion. As these are not included in incomplete biopsy specimens, histopathological assessment of such specimens can be very difficult and, at times, it may not be possible to make a definite diagnosis. The presence of biopsy related changes may also preclude a definite diagnosis being reached on a subsequent wider excision specimen that has had a previous shave or punch biopsy. Furthermore, recurrent or regenerating benign naevi that may develop after an incomplete biopsy can show some pathological features that are usually seen in melanomas and hence can be very difficult to distinguish pathologically from melanoma. DISCUSSION ONE Lesion thickness cannot be determined accurately from a shave biopsy and a punch biopsy may miss the malignant part of the lesion. These methods are sometimes used for lesions believed to be seborrhoeic keratoses and melanoma is an unexpected finding. Some doctors think a shave biopsy may give a better cosmetic result and shave or wedge biopsy can be used for large pigmented macules on the face but this should probably only be a specialist procedure. DISCUSSION ONE 15

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18 B4BB8>= &. F70C >C74A 0??A>0274B 20= F4 DB4? Dermoscopy Dr Scott Menzies Sydney Melanoma Diagnostic Centre SESSION TWO Dermoscopy is a simple, inexpensive technique that uses a magnifier with a glass plate and oil to stop reflection from the stratum corneum, to magnify skin lesions and increase diagnostic accuracy. A recent international consensus meeting reviewed definitions and methods for diagnosis of melanoma using dermoscopy. The primary aim of the meeting was to derive the best terminology for the technique and to compare four widely used surface microscopy methods for diagnosing melanoma. The summary is in press in the Journal of the American Academy of Dermatology [Argenziano et al. In press]. In an internet-based study, forty clinicians compared four diagnostic methods for melanoma using a training set of 20 and a test set of 108 pigmented lesions: ABCD Rule of Dermoscopy. This is different from the ABCD Rule of Melanoma and uses weighted factors such as asymmetry, abrupt border cutoff, specified colours and different structures to diagnose melanoma. A score > 5.45 indicates melanoma and < 4.75 indicates a benign lesion. Menzies Method. A melanoma diagnosis requires that the lesion does not show symmetry of pigmentation or have a single colour and that it possesses one of a series of positive features. 7 Point Checklist. The lesion is given two points for each major feature present and one for each minor feature. Lesions with scores of three or more are diagnosed as melanoma. Pattern analysis. This method relies on identification of characteristic melanoma features in conjunction with diagnostic experience to diagnose melanoma. As there are no set rules, it is virtually impossible to teach. The Menzies method had the highest sensitivity but was not significantly different from the other methods. Pattern analysis had a specificity about 10% higher than the other methods. The Menzies method: This method is based on the identification of features of a melanoma as seen with a dermatoscope. These include colour, asymmetry of shape and pattern, presence of pseudopods, broadened network, radial streaming and scarring. A study of the method [Menzies, 2001] showed a 92% sensitivity and 72% specificity. All lesions in the test set were atypical enough to warrant excision and in a real life situation a higher specificity would be expected. Training required: The majority of studies on the effect of training in dermoscopy have been done with experts. One study [Binder et al., 1995] showed that untrained non-experts had a SESSION TWO 17

19 decreased ability for melanoma diagnosis when using dermoscopy compared with clinical diagnosis. Experts trained in dermoscopy had a significantly higher sensitivity than non-experts and, following the publication of these results, many Colleges of Dermatologists worldwide advised general practitioners to not use the technique. A study [Stanganelli and Bucchi, 1998] of the effectiveness of training dermatologists who already used dermoscopy showed that diagnostic accuracy for melanoma was doubled after training. Another study [Binder et al., 1997] of dermatologists not currently using dermoscopy showed no difference between clinical and dermoscopic diagnosis prior to training, but a significant increase in dermoscopic ability and a significant improvement over clinical diagnosis following training. There are approximately 12 studies of diagnosis using dermoscopy but only one [Westerhoff et al., 2000] in the primary care setting. In this study, training of the intervention group was by passive learning which involved reading an atlas of dermatology [Menzies et al., 2003], at their leisure, plus a one hour talk. The control group was tested on two separate occasions and the intervention group tested before and after training. The results showed no difference in the control group on the two occasions in either clinical or dermoscopy diagnosis. In the intervention group, training increased diagnostic sensitivity for melanoma from 54.6% on pretraining clinical diagnosis to 75.9% with dermoscopy following training. A summary of the published studies that have compared dermoscopy with unaided clinical diagnosis showed an average improvement of 10% in sensitivity and specificity for experts using dermoscopy for the diagnosis of melanoma [Kittler et al., 2002]. These results all suggest that dermoscopy is a good method for diagnosing pigmented lesions when training is given. For any country where melanoma has a significant effect on morbidity and mortality, primary care physicians should learn how to use a dermatoscope. There has been no formal consumer assessment of the technique but it is painless and noninvasive. Rebates for the use of a dermatoscope are not expected from Medicare. Cost effective use of this technique would be achieved if training were to be held in a non-seminar format such as with an atlas or via the Internet. No decrease in specificity or increase in excision rates would be expected from briefly up-skilled general practitioners and, with greater experience, specificity should be improved. Total body photography I: The early detection of melanoma in high risk subjects using baseline imaging Associate Professor John Kelly Victorian Melanoma Service, The Alfred Hospital, Melbourne Change over a short period of time is one of the most important features of life threatening lesions. Baseline photography provides a record against which change can be compared and reduces the physician s reliance on the patient for the history of the lesion. 18 EFFICIENT AND EFFECTIVE MELANOMA DIAGNOSIS

20 Case-control studies have demonstrated that the strongest risk factors for developing melanoma are multiple dysplastic naevi, large numbers of naevi and a personal or family history of primary melanoma. The large number of moles and dysplastic naevi present in high risk patients make it difficult to detect changes in lesions and multiple biopsies may be performed to exclude melanoma. Baseline images of the whole body surface help to detect changes earlier and identify lesions needing further investigation. In patients with many moles, it can be difficult to decide which lesions to examine with skin surface microscopy, however, if a new or changed lesion can be identified, it becomes a candidate for closer assessment. Imaging also helps avoid unnecessary removal of many atypical but benign lesions. One method of baseline imaging involves photographing 14 standard anatomical views each documenting a recognisable body area. Anatomical markers and adhesive labels are used to delineate the extent of each view and standard magnifications, usually mandatory in medical photography, are unnecessary as the size and shape of a lesion can be assessed by comparison with adjacent lesions in the view. SESSION TWO Several studies have shown that melanomas can be detected earlier using this method. In one cohort study [Kelly et al., 1997] patients with multiple dysplastic naevi were examined and the number of naevi estimated. The patients were counselled about their risk and followed up at 6 and 12 month intervals. Only suspicious lesions were biopsied. The incidence of melanoma in this group was 46 times greater than in the general population, 5.8% of the group developed a melanoma within 42 months of follow up and the melanomas detected were on average thinner. Most melanomas were new, rather than changed lesions, thus prophylactic excision would not have prevented these. The cost per melanoma diagnosed was $5,500 which compares favourably with an estimated $400,000 per melanoma prevented if all dysplastic naevi had been initially excised. The main conclusions were that whole body photography and follow-up of patients with dysplastic naevi was a cost effective method of early detection of melanomas in high risk patients and that prophylactic excision of dysplastic naevi was inappropriate. A second cohort study [unpublished data] investigated the frequency of new lesions and changes or regression of existing lesions in a high risk population by looking for gross differences on the body map images. The average follow-up time was 18 months. There was a low rate of lesion change but a high melanoma incidence rate in this cohort (1900/100,000 person years). The frequency of changed, regressed and new naevi decreased with age but melanoma incidence increased with age and new or changed lesions in older people were more likely to be melanoma. The benign to malignant excision rate was around 3:1 overall but was lower in older than younger people. The combination of baseline imaging and skin surface microscopy was able to identify a population of lesions for which the benign to malignant biopsy ratio was 3:1. These studies show that there are substantial cost savings with body imaging. In the primary care setting, the aim should be not only to exclude melanoma but also to institute a surveillance program to enhance early detection of new primary melanoma. Individuals with melanocytic naevi and less than 10 dysplastic naevi are a group with moderately increased risk who could benefit from surveillance in a primary care setting. Specialist care is indicated for high risk individuals with more than 200 melanocytic lesions or more than 10 dysplastic naevi. SESSION TWO 19

21 Total body photography II: A randomised trial of photography as an aid to management of skin lesions in older males Dr Pauline Hanrahan Newcastle Melanoma Unit An analysis of the Newcastle Melanoma Unit s database showed 75% of patients presenting with lesions greater than 3mm were over the age of 50 and 66% of these were men. New South Wales Cancer Registry data show that over 50% of deaths from melanoma occur in men over 50 although they constitute only 12-14% of the population. Photography assists in the detection of change and the identification of new lesions and is particularly effective for this high risk group of older males whose ability to detect changing lesions on their own bodies is generally poor. In a population-based study [Hanrahan et al., 2002], 1899 men aged over 50 years were identified from the electoral roll in two regions of New South Wales and invited to participate. The 973 respondents were photographed and randomised into two groups. Over 70% of the melanomas occurring in this group occur on the upper body and photography was restricted to that site. The investigators retained the photographs from the control group while those of the intervention were mailed to the participants. All participants were advised to see their general practitioner for a standard skin examination one and two years from the time of photography. The intervention group was asked to take their photographs with them and their GPs were given an instruction sheet on the management of skin abnormalities and information on how to use the photographs. Comparisons of the management of skin abnormalities showed that for the intervention group patients (with photographs), doctors were more likely to observe a lesion, slightly less likely to excise it and less likely to use cryotherapy. Comparisons of pathology results indicated that there was a higher excision rate for lesions, such NMSC, that required removal and a lower excision rate of benign pigmented or non-pigmented lesions in the intervention group patients. Results were unchanged after adjustment for the number of patients seen by the GP and the number of lesions excised by each GP. There were too few melanomas in the group to allow for meaningful analysis. The use of the photographs resulted in considerable treatment cost savings mainly as a result of a reduction in the rate of benign lesion removal. Approximately 75% of the GPs involved in the study indicated that the photographs were of some help or were essential in their management of skin lesions. Photography increased the diagnostic accuracy of GPs and decreased the excision of benign lesions. These conclusions warrant a larger study to determine whether photography would be effective in the early detection of melanoma. 20 EFFICIENT AND EFFECTIVE MELANOMA DIAGNOSIS

22 Digital monitoring Dr Scott Menzies Sydney Melanoma Diagnostic Centre Digital monitoring is the next step up in monitoring technology. It provides a body map and digital image of the lesion using a dermoscopic imaging device with high resolution video capture for archival storage. Greater magnification can be achieved than with dermoscopy and some units provide colour calibration. The field of view varies from mm and thus is essentially single lesion surveillance. SESSION TWO Early studies were of long term interval monitoring, focusing on patients with no suspicion of malignancy. The standard mean follow-up time for this type of monitoring is about 12 months. Because many moles will show changes over this time, it is necessary to define significant change that requires excision and non-substantial benign change. Long term monitoring requires expertise and for use in a primary care setting considerable training would be required. In the study by Kittler [Kittler et al., 2001] of 1862 lesions in a group of patients with atypical moles, the median follow-up time was 12.6 months. Significant changes were defined as enlargement, change in shape or colour, regression of the lesion or the presence of specific surface microscopy features associated with melanoma. Significant change occurred in 4% of the lesions and 12% of these (8 lesions) were early melanoma. Non-substantial changes occurred in 28% of lesions. A study [Menzies et al., 2001] of short term monitoring of melanocytic lesions without evidence of melanoma, followed 245 patients for a median time of 3 months. Prior to the baseline imaging, patients were asked whether their lesions had shown any changes in pattern, colour or size. The 318 lesions followed were either moderately atypical, flat or slightly raised with no history of change, or mildly atypical with a history of change. 81% of lesions were unchanged and, of the 61 with changes, five were in situ melanomas and two were invasive melanomas. None had classical dermoscopic features of melanoma. Patient reported history of change was not predictive of subsequent change in the lesion or a diagnosis of melanoma. Sensitivity was estimated as 100% since it is predicted that all melanomas will change within 3 months. 17% of benign atypical lesions show changes within 3 months and two out of six melanomas imaged showed significant change within six days. The specificity of short term monitoring was 83%. Dermoscopy has around 92% sensitivity and for atypical lesions with no features of melanoma, short term digital monitoring could diagnose the remaining 8%. Long term monitoring requires training to select lesions with significant change. Short term monitoring requires less training because all changed lesions are excised and is thus the more attractive option for primary care. Consumer assessment studies are still to be published but it appears patients appreciate digital monitoring as they can see the basis of the physician s decision and understand that no change means safety while changed lesions require excision. Because of the longer follow-up period, the specificity of long term monitoring was greater (96%) than for short term monitoring (83%). Long term monitoring is limited to patients with atypical naevus syndrome but short term monitoring can be used for any suitable patient SESSION TWO 21

23 subset and has the potential to reduce the benign to malignant excision rate for featureless melanoma from 44:1 to around 8:1. 22 EFFICIENT AND EFFECTIVE MELANOMA DIAGNOSIS

24 B4BB8>= CF> 38B2DBB8>= Dermoscopy The question of maintenance of improved diagnostic ability in a primary care setting was discussed. Sustainability requires reinforcement of experience but the low prevalence of melanoma in general practice prevents this. A follow-up study would be useful to determine how well diagnostic ability was sustained in the absence of ongoing experience. Dermoscopy is also a valuable tool for confirming that a lesion is benign and does not require excision. This is perhaps a more important use. The high prevalence of seborrhoeic keratoses means that most lesions examined are not malignant. Dermoscopy could offer gains in specificity by reducing excision rates of benign lesions without compromising sensitivity. It is important to reassure both the doctor and the patient that a lesion does not need to be removed. DISCUSSION TWO Most studies of the effects of training in dermoscopy use as the test set a series of suspicious lesions already excised. To teach GPs how to diagnose benign lesions, training needs to be based on a mix of lesions comparable to that seen in a primary setting. Cross-infection of patients can be minimised by using 70% alcohol wipes on the dermatoscope lens between use. Total body photography There was extensive discussion about how the photographs were used in practice and the value of total body photography versus single lesion images. In clinical practice, changes seen using total body photography can be used to identify lesions that need further investigation or examination using skin surface microscopy (dermoscopy). For the cohort of patients with dysplastic naevi [Kelly et al., 1997], the benign to malignant ratio was 9:1 while the second study [unpublished data] of a high risk population using photography followed by skin surface microscopy of suspicious lesions, gave a ratio of 3:1. The photographs may be of more limited use for the detection of nodular melanomas that grow and change rapidly between follow-up visits and are often amelanotic. It can be difficult to detect or identify new lesions, even in the absence of a large number of surrounding lesions, without baseline photographs of defined body areas. The area containing any changed lesions may need to be re-photographed for subsequent follow-up. Photography of a single lesion focuses on how to deal with a specific pigmented lesion rather than monitoring the patient for new lesions. However, for larger body areas, the Rule of Seven suggests that if there are more than seven lesions in a field there is a lower chance of identifying a new one. Single lesion photography was unlikely to be used for moley patients as it was easier to monitor a group of lesions for relative change. Melanomas often arise from normal skin and these melanomas could only be detected with whole body photography. DISCUSSION TWO 23

25 The public health message is that removal of naevi is not a useful preventative measure. Photographs are a useful clinical tool but have not been found to be particularly helpful for patients themselves. Dr Hanrahan s study of the management of lesions in older males in a general practice setting was mainly concerned with the diagnosis of non-melanocytic skin cancers. There were too few melanomas to determine the effect of the intervention on melanoma diagnosis and a study to investigate this would need around 50,000 people. Digital monitoring The seven melanomas detected in the short term study [Menzies et al., 2001] showed no features of melanoma on dermoscopy and were only detected because of changes. Digital imaging was designed primarily for automated diagnosis and would be too expensive as a monitoring tool. True automated diagnosis is some way off as human pattern recognition is still better than image analysis feature extraction. There was some discussion over the distinction between lentigo maligna (Hutchinson s melanotic freckle) and lentigo maligna melanoma. Some dermatologists regard lentigo maligna as in situ melanoma, but others regard it as non-neoplastic. Increased blood flow around the tumour and vascularity within the tumour are useful signs for aiding diagnosis as 50% of melanomas have telangiectasia. The Siascope extracts tumour blush but the sensitivity and specificity of this as a diagnostic feature is unknown. 24 EFFICIENT AND EFFECTIVE MELANOMA DIAGNOSIS

26 B4BB8>= C7A44. F74A4 C> =4GC" 5DCDA4 C427=>;>684B! 7>F 20= F4?A>2443? Technologies in the future Dr Scott Menzies Sydney Melanoma Diagnostic Centre SESSION THREE These technologies are still under development and are not yet suitable for major trials in a primary care setting. The most advanced are image analysis systems that use video capture of images to give an automated diagnosis that does not rely on the clinical experience of the operator. Their principal purpose is diagnosis rather than monitoring. To date, none have been trialed clinically or have FDA approval. A meta-analysis [Rosado et al., 2003] of 10 studies comparing the performance of these instruments with expert human diagnosis found no significant difference in diagnostic accuracy. Dermoscopic images resulted in slightly better performance than ordinary clinical photographs. All image analysis systems currently available have some form of automated diagnosis. Dr Menzies is a consultant to the company producing the SolarScan and described its operation. Four dermoscopy features of melanoma are examined and rated against a cumulative histogram for each feature. These include colour irregularity, melanoma colour, size and shape and pattern irregularity. The final diagnosis is currently made by the clinician and the effectiveness of these systems still needs to be assessed with formal clinical trials. They will not be used widely unless a Medicare rebate is available. Less developed techniques include electrical impedance, ultrasound and optical coherence tomography (OCT), magnetic resonance imaging (MRI) and confocal microscopy. Ultrasound can show the size and shape of a lesion but does not give information about structure which is necessary to differentiate benign and malignant lesions. Reflectance confocal microscopy is the most advanced of the techniques. It focuses laser light into the tissue providing individual cellular detail but has limited depth penetration. Both amelanotic and pigmented melanocytes can be detected. The few published studies are based on small sample sizes and are rather anecdotal. Image analysis instruments that provide greater diagnostic accuracy than the experts will eventually be available. With the instruments currently available, over 90% sensitivity and 70% specificity could be expected in clinical trials. It is too early to assess the merits of other less advanced techniques. SESSION THREE 25

27 Assessing the diagnostic accuracy of tests Professor Les Irwig Screening and Test Evaluation Program, School of Population Health, University of Sydney. When designing a study of a diagnostic test, a series of questions should be asked: What is the clinical question? For intervention trials, the clinical question can be defined using the PICO acronym: Population, Intervention, Comparator and Outcome. For diagnostic test assessment, the acronym becomes Population, Index test, Comparator and Outcome and in this context, the Index test and Comparator terms need emphasis. For rare diseases, when assessing how the new test compares with existing technology or clinical assessment, the focus is often on improving specificity without adversely affecting sensitivity. What is the appropriate outcome? The ideal outcome is a reduction in morbidity and mortality but this may imply waiting years for the results of large randomised trials. A reference standard, such as histological assessment, is often used as a surrogate outcome but there could be situations where histology may detect abnormalities that are of little clinical relevance (such as for prostate cancer or DCIS breast lesions). In this case, the usual two by two table for test evaluation becomes a three by two table with a column for Inconsequential Disease Present. For screening tests, histological assessment may lead to an increased detection rate that might not result in improvements in long term outcomes. A more informative surrogate outcome might be a lower interval cancer detection rate. What study design will best address the clinical question? Studies need to be large and randomised. A good evaluation of a test for a relatively rare disease requires a large sample size. In dermoscopy studies, because both tests can be done on all participants, sample sizes can be reduced without loss of power. How can you avoid bias? Good studies are prospective and use real patient series. Generalisability of results can be affected by the use of artificial test sets that lead to spectrum differences in the type of lesion presented and perceptual differences for series known to be spiked with cancers. Both tests should be performed on all patients except if the tests are invasive or interfere with each other. In this case, patients should be randomised. An appropriate reference standard is needed and a procedure established for resolving conflicts in the case of equivocal results. Finally, attention needs to be paid to the blinding of the tests, the reference standards and the clinical information. How can studies of test accuracy be more efficient? The number of patients is at least halved if both tests can be done on the same person (or lesion in the case of dermoscopy). The number of patients who are verified by the reference standard can be minimized, for example, by verifying only those positive on either test or even restricting further investigation to those on whom the two tests disagree. These restrictions will 26 EFFICIENT AND EFFECTIVE MELANOMA DIAGNOSIS

28 still allow estimation of the necessary data to choose between tests or to assess the incremental value of the one test over the other. The appropriate design is easier to select if one can define whether the new test will be a replacement of the old test, will be used in addition to the old test or will be used as a triage for the old test. Each option has implications for the sample size and assessment methods used. How can you ensure that accuracy estimates are transferable? Studies must be large because heterogeneity of results in sub-groups has to be identified before results can be generalized. This may include, for example, heterogeneity across the different population groups seen by dermatologists and GPs, differences between expert and non-expert operators and differences between primary and tertiary care centres. There is merit in asking clinicians for their assessment of the probability of melanoma so that calibration and discrimination can be included in the analyses. SESSION THREE How can you evaluate rapidly evolving technology? The key issue for this point is to start evaluation as soon as the technology is introduced and to incorporate ongoing evaluation into usual practice. It is important to do a systematic review prior to the study to refine the study objectives. What is required for a Medicare rebate? Mr Mike McKenzie Health and Technology Section, Department of Health and Ageing The Medical Services Advisory Committee (MSAC) is keen to look at funding evidence based medicine. This presentation focused on the MSAC process for assessing applications for items to be included in the Medicare Benefits Schedule (MBS). The MSAC was established in 1998 to make health-financing decisions more evidence based by considering safety, effectiveness and cost-effectiveness of new and existing medical services. The MSACs terms of reference are to advise the Minister on new and/or existing medical technologies and procedures, to recommend which technologies or procedures should receive public funding (mostly via the MBS) and under what circumstances and, to undertake health technology assessment work referred by the Australian Health Ministers Advisory Council (AHMAC). Membership of the committee is subject to Ministerial approval and includes representatives from a broad range of disciplines and consumers. Applications to MSAC come from expert groups, companies or government and evaluation of new technologies or procedures is a five-stage process. All applications must demonstrate that they fill a clinical need, are eligible to be a service covered by Medicare and have relevant TGA approval. These are checked before a systematic review of safety and effectiveness is undertaken and the quality and strength of the evidence for the test or therapy is assessed. To assist MSAC, a Supporting Committee (SC) is convened. This committee consists of experts nominated from professional bodies and is chaired by an MSAC member. A contract is SESSION THREE 27

29 let with a health technology assessment agency to undertake a cost-effectiveness evaluation and prepare a report. Australia is one of the few countries to link funding to evidence-based medicine and the cost-effectiveness analysis is central to this. The principal interest is in how the cost-effectiveness of the proposed test or technology compares with existing arrangements. The SC then drafts their proposed recommendations regarding public funding. The applicant reviews the draft report, but not the proposed recommendations, and provides feedback. This, along with the report and recommendations, is then sent to MSAC who formulate their advice to the Minister. The Minister may accept or reject MSAC s recommendation. To date, approximately 43% of the evaluations have recommended support for funding on the MBS, 36% have recommended interim funding and for the remainder funding has not been recommended, usually because randomised controlled trial evidence was lacking. If funding is approved, a tabling committee negotiates an MBS item descriptor and fee with members of the profession. MSAC Reports (including recommendations, Ministerial endorsement or other notation) are available in hard copy or from the MSAC web site at: Medico-legal problems with melanoma patients Professor Gerry W. Milton Skin and Cancer Foundation Australia In Jackson s review of 75 malpractice cases [Jackson, 1997] relating to patients suffering from malignant melanoma, the main cause of litigation was a failure to biopsy a lesion resulting in a delay in diagnosis and treatment. Failure to biopsy may be due to missing a melanoma on a mole check or assuring the patient that a lesion they are concerned about is benign. In all the reviewed cases and all the cases from Professor Milton s experience, the litigation arose after the patient had complained more than once about a specific lesion, was reassured that it was benign but the lesion was subsequently diagnosed as melanoma. This type of error is not restricted to GPs. The clinical history of the patient should be augmented by the history given by family members, particularly for lesions on body areas not easily visible to the patient. To avoid litigation a doctor must include a history taken from family members, from the patients themselves and listen to what the patients are saying. Repeated complaints about the same lesion may indicate significant changes that the patient cannot adequately describe and excision is nearly always the wisest course. Images using photographs or other technology are very useful. 28 EFFICIENT AND EFFECTIVE MELANOMA DIAGNOSIS

30 B4BB8>= C7A44 38B2DBB8>= Future technologies Confocal microscopy in conjunction with monoclonal antibodies in a skin-penetrating vehicle could be used to study the individual cell morphology and cell surface marker expression and perhaps to determine whether there are cells with metastatic potential. Animal studies using systemic injection of the antibodies have been published but, for human applications, administration of the antibodies would need to be via the skin. The laser used in confocal microscopy has a limit of penetration particularly in heavily pigmented lesions. Important features are often deeper than this in the dermo-epidermal junction and diagnoses could be missed with this technique. There is no existing technology that can actually diagnose melanoma. This is still done by a clinical assessment with or without the aid of images. Patients whose melanomas were first detected using imaging technology, such as MoleMax, may believe the machine made the diagnosis as the publicity surrounding the machines may give this impression. DISCUSSION THREE Malignant melanocytes are different spectroscopically from benign melanocytes and MRI spectroscopy with or without antibodies could be the most accurate diagnostic technique for detecting malignant melanocytes in the skin. The technology was discussed at a recent conference on sentinel lymph nodes but there is a difference between detecting melanocytes in a lymph node and differentiating between melanocytes in a dysplastic naevus and melanoma. There has not yet been enough work with melanocytic lesions to determine whether MRI imaging would be a useful tool. There has been limited investigation of MRI spectroscopy in other tumour systems such as cervical cancer, but the work is still unpublished. A difficulty encountered in diffuse reflective confocal spectroscopy is the localisation of the point of the reading to the histological location in the lesion. One manufacturer was planning to make a reflectance in vivo confocal microscope that used a dermoscopic image of the site to help pinpoint the location of the reading but the current status of this work was unknown. Test accuracy It is important to gain an understanding of how clinicians make decisions. This is assisted by getting clinicians to record their estimate of the diagnostic probability of a lesion being melanoma. Studies collecting such information can be quite complex to perform and analyse but will lead to more informative results about how clinicians arrive at a particular diagnostic threshold. DISCUSSION THREE 29

31 Medicare rebate All MSAC reports, both positive and negative, are considered by the Minister and thus far, all recommendations have been approved. Cost-effectiveness analyses are restricted to the present day costs and it is not part of the MSAC purview to take future savings into account. The mechanism for deleting an item from the MBS is rarely used. It requires expensive evidence-based assessments and can be a cost-ineffective process for items that are not claiming any funds. Unsafe or incompetent practices should be removed but this does not appear to happen. The effect of changes to the MBS are not routinely monitored to determine whether they have had the desired or an adverse effect Interim funding for two years can be recommended for applications that require further evidence before a final decision is made. Medico-legal issues In relation to relying on the patient s history of a lesion, a study by Menzies [Menzies et al., 2001] found that 8% of melanomas were featureless and that 11 out of 12 of these were excised only because of a history of change but there was no correlation between patient history and subsequent melanoma diagnosis. History appears to be particularly important for amelanotic melanomas. The patient history is the best source of information in general practice where diagnosis is more difficult. GPs see thousands of moles each year but only about one melanoma. Most thick lesions now diagnosed are nodular melanoma and most of these are amelanotic, have a single colour and do not conform to the ABCD rule. These lesions grow quickly and often occur on the head or neck where they should be seen. GP and public awareness of this type of melanoma needs to be raised through education programs. There is a conflict between reducing the benign to malignant ratio and excising lesions to avoid medico-legal action. Medico-legal pressure is substantial and likely to influence behaviour but there is also pressure to reduce health care costs. The problem is to how achieve a balance between the two. Most litigation arises out of a failure of communication. Patients and their families need to be given information about the probability of a lesion being malignant and the options and side effects of particular treatments including monitoring. There will always be some lesions that will be missed through no fault of the doctor but repeated requests for biopsy of a specific lesion should never be ignored. 30 EFFICIENT AND EFFECTIVE MELANOMA DIAGNOSIS

32 58=0; 38B2DBB8>= How do we proceed? The aim of the final group discussion was to identify key areas that were ripe for development in a primary care setting and to reach consensus on some of the significant issues arising from the presentations and discussions. We need to maintain or even increase the effectiveness of melanoma diagnosis and at the same time increase diagnostic efficiency by reducing the number of benign excisions. The changes in patterns of care and the use of technology need to be better understood as part of this process. FINAL DISCUSSION The priority areas identified for further discussion were: 1. Simple photography The Del Mar and Green trial suggested that photography, allied with clinical decision making, was a simple intervention that could safely decrease the benign biopsy rates. The Perth trial of the same intervention found that photography in the primary care setting was ineffective in reducing the benign to malignant excision ratio. Is this intervention worth pursuing? 2. Training in dermoscopy There were encouraging results from one study of training and utilisation of dermoscopy in primary care. The next step with this technology needs to be determined. Do we need a large scale study, a demonstration project or should this technique simply be allowed to diffuse into general practice? 3. Base line total photography Impressive results were obtained from a randomised trial of baseline photography in men over 50 years. Skin monitoring in these men led to fewer benign lesions being excised and a higher excision rate for lesions such as NMSC that required removal. Does this technique need further development or could we incorporate it into a study of dermoscopy? 4. Dedicated skin cancer clinics There have been changes in GP referral patterns and some patients now attend specialised general practice skin clinics directly rather than seeing their own GP. Information is lacking on the use of dermoscopy or other technologies by these clinics or their biopsy yield compared with ordinary general practice. Should we observe, evaluate or introduce demonstration projects in these clinics? Research could be conducted to ascertain the rates of diagnosis of patients in areas or Divisions of General Practice where these clinics operate and referral patterns have changed most. FINAL DISCUSSION 31

33 5. Medical education in the diagnosis of skin lesions Undergraduate medical training focuses on diagnosing melanomas. Benign lesions are much more common and there needs to be more emphasis on training to accurately identify these lesions. Professor Elwood then invited discussion from the audience on any of the above topics that would benefit from further research and development. Simple photography Possible explanations for the difference in results of the two studies of this technique were noted. In the period between the studies, new items for melanoma excision were added to the MBS and the rebates increased for melanomas. This encouraged the removal of pigmented lesions and led to an increase of $4 million per annum for excisions. Any melanoma found attracted a higher rebate and the change was referred to as Mole Lotto. There were few referral sources in the Queensland trial so GPs handled most of the cases themselves. In Perth, data for patients referred to a specialist were unavailable for the analysis. Changes in referral patterns over the time between the studies could also have been an important factor. The randomisation by practice in Perth may have resulted in contamination if patients moved from control practices to intervention practices that used the camera but this would have led to an effect opposite to that seen. There was little support for pursuing further studies of this intervention but it was acknowledged that a one size fits all solution might not be appropriate. Different approaches may suit different settings and an instant camera may still be useful in a rural setting. Data are needed over a 5-6 year period on how GPs manage lesions. Dermoscopy Is dermoscopy at the stage where it can be implemented in the primary care setting or do we need further information and what steps are needed to proceed? The benefits of dermoscopy are in reducing benign excisions. It is a useful tool for reassurance about benign lesions and is also helpful for deciding which lesions to remove. Testing the results of training is straightforward but a better endpoint for a study might be which pigmented lesions are excised rather than which ones are melanomas. Phased implementation of one or more interventions could be introduced to determine whether avoiding biopsy of benign lesions reduced the sensitivity for melanoma. Studies with melanoma endpoints could be then introduced. The advantage of dermoscopy is its low cost and the robust evidence of its effectiveness. It is also used as an adjunct to most other techniques and it would have to be included in any intervention. We need to identify GPs who remove a large number of lesions, determine what tools they use and investigate urban and rural differences. If there were a trend to concentrate removal of skin lesions in groups of GPs who identify themselves as skin cancer clinics, then a dermoscopy 32 EFFICIENT AND EFFECTIVE MELANOMA DIAGNOSIS

34 trial would work best in that setting as these doctors would use the instrument frequently. This intervention might not be applicable to remote areas where GP see few melanomas and simple photography might work best in that situation. A complementary study of high risk groups of patients such as those over 50 years with more than a specified number of moles could be considered. Suitable patients could be identified by prevalent examination. Females aged 30 years have the highest risk of lesion removal but men over 50 have the greatest melanoma risk. There was support from participating GPs for training in the use of dermoscopy to identify benign lesions. The financial investment by the GP in buying a dermatoscope and atlas would be offset by the improvement in diagnostic skills that could be achieved and a reduction in the benign excision rate. There is a distinction between clinical diagnosis of a specific lesion and finding a melanoma during a patient or doctor initiated skin examination. The excision and diagnosis rates may differ and if the reason for presentation affects the excision rate, presentation differences need to be dealt with separately when designing a study or separate studies should be considered. FINAL DISCUSSION To develop sufficient confidence in the technique to promote widespread use in primary practice, a randomised trial comparing usual clinical practice with dermoscopy would have to demonstrate that dermoscopy can be used to accurately identify innocent lesions. Photographic records of the dermascopic images could be reviewed to determine whether lesions diagnosed as benign by the GP were considered benign by an expert. If the focus is on correct identification of innocent lesions an appropriate target group is young people. The concordance between decisions based on photographic images and 3 month follow-up of all lesions could be estimated as could concordance between histology of excised lesion and images. The GP s assessment of the probability that a lesion is malignant may provide additional information. Overall, this trial is similar in concept to that of the Perth Trial but has a different endpoint. We should not design studies aimed at reducing excision rates, as the downstream cost might be a reduction in sensitivity for melanoma. Both need to be examined simultaneously with a cut-off defined such that if an intervention does not meet a given specificity we do not proceed. Total Body Photography The presentations covered two applications of total body photography. The first was surveillance of high risk patients for melanoma and was not aimed at reducing the benign excision rate. The second application was screening for skin cancers, particularly NMSC in older men. A study of total body photography in primary practice should be aimed at testing the ability of GPs to identify patients at high risk of melanoma and to instigate a surveillance program using baseline imaging. The outcome would be melanoma detection rates and, in this case, age is a less important risk factor than total number of moles or dysplastic naevi or a personal or family history of melanoma. FINAL DISCUSSION 33

35 Education Education of doctors in diagnosing benign lesions is crucial. One reason for the difference in results of the Perth trial and the Del Mar and Green trial may have been that doctors did not have previous training or sufficient confidence to make a diagnosis. They may have opted for excision because they were in the study resulting in no change in the excision rates. Tele-dermoscopy (diagnosis using images transmitted across the Internet) was not discussed in any of the presentations but there was a question about the use of digital photography in this context. Dermatology was more suited to tele-medicine than any other branch of medicine and dermoscopy fitted this particularly well. There have been studies in an expert setting showing that diagnosis across the Internet was equally effective as diagnosis with the patient in the room. There are also studies and anecdotal reports indicating that it is not nearly as good. Studies could be considered for Australia. The medico-legal risks of this technology should be no different from those with the patient sitting in front of a doctor. Consumer Comment Mr John Stubbs of the Cancer Alliance Network spoke regarding the workshop s proceedings from a consumer point of view. He concluded that the day had been very positive with new ideas, new concepts and new techniques discussed. Improved education of doctors and medical students is a very positive move particularly from a consumer and health user point of view. The discussions on better use of cost effective methods was also very positive as consumers are aware of the pressure on MBS and PBS. Any reductions in cost or improvements in education will be beneficial to the consumer. Finally, one of the most important messages to come from the workshop proceedings was that of listening to patients. Consumers have more access to information via the Internet, advocacy groups and user groups and, as a result, are becoming better informed. Therefore it is vitally important to listen to what patients say. Final conclusions A future study will be developed by a small working party to assess the effectiveness of one or more of the melanoma diagnostic techniques listed above. Professor Elwood indicted that he will work with Queensland study groups to get a better understanding of the role of Skin Cancer Clinics in that region and will move forward with their assistance in respect to dedicated skin cancer clinics and medical education. The issue of education will depend upon the results of future studies of diagnostic techniques to ensure the most effective diagnostic method is introduced and taught to doctors working in the primary care setting. 34 EFFICIENT AND EFFECTIVE MELANOMA DIAGNOSIS

36 A454A4=24B Australian Institute of Health and Welfare and Australasian Association of Cancer Registries. Cancer in Australia AIHW cat. no. CAN 15, i Canberra, AIHW (Cancer Series no. 20). Binder M, Puespoeck-Schwarz M, Steiner A, Kittler H, Muellner M, Wolff K, Pehamberger H (1997) Epiluminescence microscopy of small pigmented skin lesions: short-term formal training improves the diagnostic performance of dermatologists. J Am Acad Dermatol 36: REFERENCES Binder M, Schwarz M, Winkler A, Steiner A, Kaider A, Wolff K, Pehamberger H (1995) Epiluminescence microscopy. A useful tool for the diagnosis of pigmented skin lesions for formally trained dermatologists. Arch Dermatol 131: Del Mar CB, Green AC (1995) Aid to diagnosis of melanoma in primary medical care. BMJ 310: Hanrahan PF, D'Este CA, Menzies SW, Plummer T, Hersey P (2002) A randomised trial of skin photography as an aid to screening skin lesions in older males. J Med Screen 9: Jackson R (1997) Malignant melanoma: a review of 75 malpractice cases. Int J Dermatol 36: Kelly J, Yeatman J, Regalia C, Mason G, Henham A (1997) A high incidence of melanoma found in patients with multiple dysplastic naevi by photographic surveillance. Med J Aust 167: Kittler H, Pehamberger H, Wolff K, Binder M (2001) Follow-up of melanocytic skin lesions with digital epiluminescence microscopy: patterns of modifications observed in early melanoma, atypical nevi, and common nevi. J Am Acad Dermatol 43: Kittler H, Pehamberger H, Wolff K, Binder M (2002) Diagnostic accuracy of dermoscopy. Lancet Oncol 3: Menzies SW (2001) A method for the diagnosis of primary cutaneous melanoma using surface microscopy. Dermatol Clin 19: Menzies SW, Crotty KA, Ingvar C, McCarthy WH (2003) An atlas of surface microscopy of pigmented skin lesions: dermoscopy. McGraw-Hill: Sydney Menzies SW, Gutenev A, Avramidis M, Batrac A, McCarthy WH (2001) Short-term digital surface microscopic monitoring of atypical or changing melanocytic lesions. Arch Dermatol 137: Rosado B, Menzies S, Harbauer A, Pehamberger H, Wolff K, Binder M, Kittler H (2003) Accuracy of Computer Diagnosis of Melanoma: A Quantitative Meta-analysis. Arch Dermatol 139: Stanganelli I, Bucchi L (1998) Epiluminescence microscopy versus clinical evaluation of pigmented skin lesions: effects of Operator's training on reproducibility and accuracy. Dermatology and Venereology Society of the Canton of Ticino. Dermatology 196: Ward J, Boyle K (1994) General practitioners' estimates of the ideal benign-to-malignant ratio for excised pigmented lesions. Aust J Public Health 18: REFERENCES 35

37 Westerhoff K, McCarthy W, Menzies S (2000) Increase in the sensitivity for melanoma diagnosis by primary care physicians using skin surface microscopy. Br J Dermatol 143: EFFICIENT AND EFFECTIVE MELANOMA DIAGNOSIS

38 ;8BC >5?0AC828?0=CB Dr Fiona Ainley Canberra Skin Cancer Clinic Dr Joanne Aitken Queensland Cancer Fund Ms Kris Ashpole The Cancer Council NSW Dr Anthony Baingakulum GP Merimbula NSW Ms Irena Brozek The Cancer Council NSW Professor Robert Burton National Cancer Control Initiative Ms Julie Claessens Consumer Alliance Network Professor Alan Coates The Cancer Council Australia Dr Brian Cole Walton Bridge Medical Centre QLD Dr Judy Cole St John of God Dermatology, WA Dr Diona Damian Department of Dermatology RPAH Sydney Professor Chris Del Mar University of Queensland Medical School Ms Anna Doubrovsky Melanoma Foundation University of Sydney Professor Mark Elwood National Cancer Control Initiative Dr Dallas English The Cancer Council Victoria Dr Stephen Foster Melanoma Centres Brisbane Dr Irene Giam Canberra Skin Cancer Clinic Associate Professor Afaf Girgis The Cancer Council NSW Professor Adele Green Queensland Institute of Medical Research Dr Pauline Hanrahan Melanoma Unit Newcastle Dr Martin Haskett Victorian Melanoma Service Ms Amanda Henham Skinsense Imaging Newcastle Professor Peter Hersey Mater Misericordiae Hospital Newcastle Professor Les Irwig University of Sydney Associate Professor John Kelly Victorian Melanoma Service Ms Amanda Mackley Mater Misericordiae Hospital Newcastle Professor Robin Marks University of Melbourne Ms Jennifer Martin Mater Misericordia Hospital Newcastle Professor Brian McAvoy National Cancer Control Initiative Professor Bill McCarthy Sydney Melanoma Unit Dr Mike McKenzie Department of Health & Ageing Dr Scott Menzies Sydney Melanoma Diagnostic Centre Professor Gerry Milton Skin & Cancer Foundation Australia Dr Howard Peach Sydney Melanoma Diagnostic Centre Ms Liz Pugh Department of Health & Ageing Dr Chris Quirk Dermatologist WA Dr Richard Scolyer Dermatopathologist Dr John Simonidis Brisbane Melanoma Service Dr Mark Smithers Brisbane Hospital Melanoma Unit Ms Margaret Staples National Cancer Control Initiative Ms Jacquie Stratford Melanoma Foundation & MASCRI Mr John Stubbs Consumer Alliance Network PARTICIPANTS PARTICIPANTS 37

39 Ms Belinda Summerville The Cancer Council NSW Dr Tony Watson GP London UK Dr David Whiteman Queensland Institute of Medical Research Ms Jodie Williams National Cancer Control Initiative 38 EFFICIENT AND EFFECTIVE MELANOMA DIAGNOSIS

40