Cancer

Breast cancer mortality trends in Australia: 1921 to 1994 Catherine L Smith, Anne Kricker, Bruce K Armstrong MJA 1998; 168: 11-14 Abstract - Introduction - Methods - Results - Discussion - Conclusions - Acknowledgements - References - Authors' details - - ©MJA1997 Abstract Objective: To analyse breast cancer mortality trends in Australia and to see if mammographic screening has yet led to a reduction in mortality. Design: Retrospective analysis of trends in mortality rates from breast cancer in Australian women between 1921 and 1994, and in potentially explanatory variables such as fertility, body size, age at menarche, and screening. Results: Changes in breast cancer mortality in Australian women could not be explained by chance variation alone. Mortality rose steadily (average annual increase, 1.0%) to 1940-1944, fell to the 1960s and early 1970s, and rose (average annual increase, 0.3%) to the late 1980s. Between 1985-1989 and 1990-1994, breast cancer mortality fell by 3.2% in women 50-69 years of age (the target age group for mammographic screening) and by 4.2% in women 25-49 years of age. There was almost no change ( - 0.2%) in breast cancer mortality in older women in this period. The proportion of women screened in all age groups increased substantially between 1988 and 1994; nearly 65% of women in the target age group had had at least one mammogram by 1994. Decreases in fertility were followed by increases in mortality, and vice versa. Conclusions: Trends in breast cancer mortality have probably been influenced by changing fertility, nutrition and body-size increases among Australian women. Improvements in stage at diagnosis and treatment have probably moderated the upwards pressure on mortality caused by an increasing incidence. Recent falls in mortality could be expected to continue as more women participate in the mammographic screening program. This trend should be more clearly evident in the second half of the 1990s. Introduction Breast cancer mortality in women in most developed countries, including Australia, has levelled off or fallen in recent years.1 In Britain, an important fall in mortality since 1989, considered too early to be the result of mammographic screening, is thought to be the result of improved treatment.2 Similar observations have been made in the United States.3 We examined trends in breast cancer mortality and breast cancer risk factors in Australia between 1921 and 1994 to see if we could explain recent mortality changes and, in particular, to see if mammographic screening has yet led to decreased breast cancer mortality in the target age group for screening (50-69 years). Methods Age-specific and age-standardised mortality rates from breast cancer per 100 000 woman-years, standardised to the world population, were calculated for one four-year period (1921-1924) and 14 five-year periods (1925-1929 to 1990-1994) from annual mortality and population data from the Australian Bureau of Statistics. Rates for 1995 have subsequently been released. Estimates of the number of women who had had at least one mammogram by the end of each year from 1984 to 1994 were obtained as follows: Annual numbers of women by age having a first or subsequent bilateral mammogram (bilateral mammograms being most likely for screening purposes) under Medicare from 1984 to 1994 were estimated from data of the Commonwealth Department of Health and Family Services; Annual numbers of first screens in 10 pilot projects of the national screening program were estimated by age from 1 January 1988 to 30 June 19914-7 (BreastScreen Australia, personal communication) on the assumption, where necessary, that all screens were initial and that rates were constant within and over time periods and age groups; and Similar estimates were made for BreastScreen Australia from 1 July 1991 to December 1994 by applying the age distribution for all screens, initial and subsequent, in Victoria8 (BreastScreen Australia, personal communication) and New South Wales9 to published national screening estimates,9 and by estimating the fraction that were initial screens from State-based proportions of initial screens. These three sets of estimates were totalled to estimate numbers of women who had had at least one mammogram by the end of each year from 1984 to 1994. Total fertility rates by age in Australian women were obtained by year from 1921 to 1994.10,11 Rates of first births by age and year, available only for married women, showed patterns similar to those for total fertility. Results Mortality Breast cancer mortality (Box 1a) increased in Australia between the periods 1921-1924 and 1940-1944 (average annual increase, 1.0%), fell to a post-war low around 1960, and increased slowly again to a peak in 1985-1989. The average annual increase in rates from 1970-1974 to 1985-1989 was 0.3%. Thereafter, rates fell by 0.5% a year between 1985-1989 and 1990-1994. The recent fall in annual age-standardised rates has been from 20.7 per 100 000 woman-years in 1990 and 1991, to 19.6 per 100 000 in 1992, 1993 and 1995, and 19.2 in 1996; in 1994 the mortality rate was 20.3 per 100 000 woman-years. Age-specific mortality rates for women aged 25-49 years showed little change between 1921 and 1994 (Box 2). In women 50 years of age and older, breast cancer mortality rose steadily to reach initial peaks at different times between 1935-1939 and 1950-1954. These peaks occurred in women born between 1865 and 1885. Mortality in women 50 years and older then fell to a post-war low between 1950-1954 and 1985-1989 depending on age group and occurring in women born around 1890 to 1905. Thereafter, mortality rates again rose and appeared to peak in 1980-1984 or 1985-1989 for each age group of women from 50-54 years to 70-79 years. There was little evidence of this later mortality rise in women older than 80 years. In the target age group for mammographic screening (50-69 years), the age-standardised mortality rate increased by 4.0% (95% CI, - 0.1 to 8.3) from 1980-1984 to 1985-1989 and then fell by 3.2% (95% CI, - 6.9 to 0.6) to 1990-1994. In women 25-49 years of age, rates increased by 7.5% (95% CI, 0.4-15.0) from 1980-1984 to 1985-1989 and then fell by 4.2% (95% CI, - 9.9 to 1.9) to 1990-1994. Women 70 years of age and older showed only weak evidence of change from the early to the late 1980s (1.3%; 95% CI, - 3.1 to 6.0) and almost no evidence of a fall in the 1990s ( 2 0.2%; 95% CI, - 4.2 to 4.0). Mammographic screening Our analysis of mammographic screening data is summarised in Box 3. The percentages of women screened between 1988 and 1994 increased in all age groups, most notably in women aged 50-69 years. The beginning of most pilot projects in late 1988 and early 1989 and of the National Program in 1991 led to a substantial change in the age distribution of screening mammograms. There was a nearly sevenfold increase in the cumulative numbers of women in the target age group who had been screened once or more, from around 138 000 in 1988 to nearly one million by 1994. The estimated number of women under 50 years of age who had been screened (which was twice the number in the target group in 1988) increased only 3.7 times (to an estimated 1 140 000) by 1994. By 1994, about 70% of women in their 50s and 58% of women in their 60s had had an initial screen. In all, 54% of women in their 40s and 22% of women younger than 40 were estimated to have been screened once by 1994. In older women, the proportion screened reached 25% at 70-74 years of age and 6% at 80 years and older. Fertility Fertility fell at all ages from 1921-1924 or 1925-1929, to reach a minimum in most age groups in 1930-1934 or 1935-1939 (Box 1b), and then rose to reach a peak between 1945-1949 and 1970-1974. Rates again fell from these peaks. Minima were reached in 1975-1979 or 1980-1984 in those aged between 30 and 44 years, with subsequent rises to 1990-1994. There was little evidence that any of these trends related better to cohort of birth than time period. Discussion Compared with many other countries, breast cancer mortality in Australia has varied little over the past 75 years.1 However, the clear trends we found cannot be explained by chance fluctuation. The recent fall in the early 1990s, while apparently quite definite in women aged 40-69 years, could be a chance occurrence and will need to be shown for several more years for it to be declared a "real" trend. There are three broad classes of explanation for these trends, represented under the subheadings below. Changes in how cause of death is registered and coded can influence reported cause-specific mortality rates, but no substantial changes of this kind are known to have occurred in Australia.1,12 We have specified "real" incidence (below) because recent apparent increases in breast cancer incidence have probably been the result of increased screening.3,13 These increases will not cause increases in mortality because they reflect either earlier diagnosis of breast cancers, or the diagnosis of lesions that would otherwise never have been detected.13 Changes in determinants of real incidence Incidence trends: Whether changes in incidence caused changes in mortality would be most easily determined by comparing incidence and mortality trends. Incidence of breast cancer in New South Wales (representing about one-third of Australian women) changed little from 1972 to 1983, but increased steadily from 1984, and by 1995 was nearly 50% higher than it was in 1983.14 The greatest increase was in women in the target age group for mammographic screening (50-69 years). As there was no parallel increase in mortality during that period, the observed increase in incidence has probably been caused by screening. Incidence was not measured in Australia before 1972. However, it is most likely that incidence rates in Australia, as in several other countries,15-17 were increasing and thus underlie the steady increase in mortality from 1921 to the peak of the mid 1940s. Incidence rates in Australia were probably also increasing in the post-war period, as in other populations of European origin,18,19 when Australian mortality rates were falling or stable. Fertility: Breast cancer is associated with late age at first birth, childlessness and low parity.13 Box 1 shows that Australian trends in rates of mortality from breast cancer moved in the opposite direction from those of fertility rates, with changes in mortality occurring a few years after those in fertility. Australian women born in the 1840s were at the forefront of a transition to lower family sizes in English-speaking countries.10 This falling fertility could have produced the increasing mortality from breast cancer from 1921 onwards. The peak breast cancer mortality in the 1940s occurred in women born before 1885; the highest proportions of unmarried and childless women seen in Australia up to the 1940s were among those born in 1871 to 1876.10 The upward trend in fertility after 1935, which peaked in 1955-1964, started about 10 years before mortality began to fall in the mid 1940s. Fertility again fell in the late 1960s and 1970s to a new low in the 1980s, with a pronounced shift during that period to later childbearing; mortality began to rise again in the 1980s. Body size and age at menarche: Each 5-cm increase in average height in adult women has been estimated to increase breast cancer risk by 10%.13 From the early 1900s to about 1980, net increases of 8-9 cm in height and 10 kg in weight20,21 could have contributed appreciably to increases in mortality in women born from about 1895 to 1935 (evident in overall mortality from breast cancer between 1970-1974 and 1985-1989). A fall in age at menarche is also associated with an increase in breast cancer incidence.13,22 Trends in Australia, probably similar to the 2-3 months' fall per calendar decade seen in the United Kingdom and United States in the 100 years to about 1950,13,22,23 would have been expected to increase breast cancer rates. Younger age at menarche is very likely caused by increased height and body mass index, perhaps because menarche depends on attainment of a critical body mass.22,24 Diet: Dietary changes may have affected breast cancer rates by way of changes in body size, and possibly by other means.25 Alcohol consumption is associated with increased risk of breast cancer, being 35% higher in women who have 2-4 drinks and 67% higher in those who have more than four drinks a day compared with women who drink little or no alcohol.26 The high alcohol consumption among Australian women of the early 1800s was not equalled again until 1989, when more than 50% of women over 18-20 years were consuming up to two drinks a day.26,27 However, it has been estimated that no more than 3% of breast cancers in Australia in 1990 were the result of drinking more than two drinks of alcohol a day.26 Physical activity may reduce risk of breast cancer.27 The proportion of Australian women who participate in any recreational exercise (around 70%) appears not to have changed in recent times.28 Changes over time in the physical activity associated with running a household and in paid employment have not been measured. Migration: Breast cancer rates vary six-fold internationally.29 Migration of women from countries of higher (UK) and lower (eastern Europe, southern Europe, Asia) breast cancer mortality than in Australia has varied, but the net effect of migration on breast cancer mortality rates has probably been small. Oestrogen use: Use of the oral contraceptive pill increased rapidly in Australia after its introduction in 1961.30 If the Pill has caused an increase in breast cancer mortality, it would have done so mainly in younger women who were current or recent users.31 The increase in mortality in the late 1980s, however, was mostly in women over 50 years of age. Falling mortality from breast cancer in the generations of women who first used oral contraceptives in the US, UK and Sweden also suggests no major effects of the Pill on breast cancer rates.32,33 The use of oestrogen replacement therapy, which may increase breast cancer risk, has probably not affected breast cancer incidence appreciably as long term use has been uncommon in Australia. Changes in determinants of stage at diagnosis Trends to smaller breast cancers and fewer axillary node metastases over nearly 100 years34-36 are probably the results of increased access to and use of care. The trend to more localised disease is probably continuing because of increased screening.3,13,37 Such trends would have caused downward pressure on breast cancer mortality. Mortality from breast cancer in Australian women in the target age group for screening (50-69 years) fell by 3.2% between 1985-1989 and 1990-1994. This may be the result of screening, although the same or larger falls in mortality also occurred in younger women, for whom there is little evidence that mammographic screening reduces breast cancer mortality.38 Changes in determinants of probability of survival after diagnosis at a particular stage The effectiveness of radical mastectomy as the primary treatment for breast cancer has probably changed little in the past 100 years. However, advances in anaesthetics and operating conditions38 as well as the recent use of adjuvant chemotherapy and hormonal therapy3,39 have almost certainly increased survival. Conclusions While no certain conclusions can be drawn about the causes of changes in breast cancer mortality since 1921, it is probable that the increase to the mid 1940s was caused mainly by rapidly falling fertility in the latter part of the 19th and the early 20th centuries. Subsequent increased fertility, and earlier diagnosis, may have contributed to the fall in mortality from 1940-1944 to 1960-1964. The increasing mortality in women born between 1895 and 1935 was probably caused by nutritional factors leading to increases in body size and resultant earlier age at menarche. However, this incidence-driven increase in mortality was probably moderated by increasing survival with earlier diagnosis and, more recently, improved treatment. Improved treatment is probably the reason for cross-sectional falls in mortality between 1985-1989 and 1990-1994 in women up to 69 years of age. Early effects of mammographic screening may have contributed to these falls, but should be more clearly evident in the second half of the 1990s. Acknowledgements Australian Bureau of Statistics data on mortality from breast cancer from 1921 to 1994 were supplied by Mr Paul Jelfs from the national mortality database at the Australian Institute of Health and Welfare, Canberra. References Hermon C, Beral V. Breast cancer mortality rates are levelling off or beginning to decline in many western countries: analysis of time trends, age-cohort and age-period models of breast cancer mortality in 20 countries. Br J Cancer 1996; 73: 955-960. Beral V, Hermon C, Reeves G, Peto R. Sudden fall in breast cancer death rates in England and Wales [letter]. Lancet 1995; 345: 1642-1643. Chu KC, Tarone RE, Kessler LG, et al. Recent trends in US breast cancer incidence, survival, and mortality rates. J Natl Cancer Inst 1996; 88: 1571-1579. Essendon Breast X-Ray Program Collaborative Group. A mammographic screening pilot project in Victoria 1988-1990. Med J Aust 1992; 157: 670-673. Rickard MT, Lee W, Read JW, et al. Breast cancer diagnosis by screening mammography: early results of the Central Sydney Area Health Service Breast X-ray Programme. Med J Aust 1991; 154: 126-131. Robinson JI, Crane CEB, King JM, et al. The South Australian Breast X-Ray Service: results from a statewide mammographic screening programme. Br J Cancer 1996; 73: 837-842. Australian Health Ministers' Advisory Council. Breast Cancer Screening Evaluation Committee. Breast cancer screening in Australia: future directions. Canberra: AGPS, 1990. Victorian Breast Screening Program. Annual statistical report 1994. Melbourne: Victorian Breast Screening Program, 1996. Smith D, Oudod V, Supramaniam R, et al. BreastScreen NSW Statistical Report 1991 to 1995. Sydney: NSW Cancer Council, 1996. McDonald P, Ruzicka L, Pyne P. Marriage, fertility and mortality. In: Vamplew W, editor. Australians: historical statistics. Sydney: Fairfax, Syme and Weldon, 1987: 44-61. Australian Bureau of Statistics. Births, Australia. Canberra: AGPS, 1995. (Catalogue No. 3301.0.) Fleming NT, Armstrong BK, Sheiner HJ, James IR. Occurrence of breast cancer in Australian women. Med J Aust 1981; 1: 289-293. Ursin G, Bernstein L, Pike MC. Breast cancer. Cancer Surv 1994; 19-20: 241-264. Cancer Control Information Centre. Breast cancer incidence, 1995. Sydney: NSW Cancer Council, 1996. Wigle DT. Breast cancer and fertility trends in Canada. Am J Epidemiol 1977; 105: 428-438. Stevens RG, Moolgavkar SH, Lee JA. Temporal trends in breast cancer. Am J Epidemiol 1982; 115: 759-777. Ewertz M, Carstensen B. Trends in breast cancer incidence and mortality in Denmark, 1943-1982. Int J Cancer 1988; 41: 46-51. Tulinius H, Sigvaldason H. Trends in incidence of female breast cancer in the Nordic countries. In: Magnus K, editor. Trends in cancer incidence. Washington: McGraw-Hill, 1982: 235-247. Nab HW, Mulder PG, Crommelin MA, et al. Is the peak in breast cancer incidence in sight? A study conducted in the southeastern Netherlands. Eur J Cancer 1994; 30A: 50-52. May GM, O'Hara VM, Dugdale AE. Patterns of growth in Queensland schoolchildren, 1911 to 1976. Med J Aust 1979; 2: 610-614. Hitchcock NE, Maller RA, Gilmour AI. Body size of young Australians aged five to 16 years. Med J Aust 1986; 145: 368-372. Henderson BE, Bernstein L. The international variation in breast cancer rates: an epidemiological assessment. Breast Cancer Res Treat 1991; 18 Suppl 1: S11-S17. Frisch RE. Body weight, body fat, and ovulation. Trends Endocrinol Metab 1991; 5: 191-197. Petridou E, Syrigou E, Toupadaki N, et al. Determinants of age at menarche as early life predictors of breast cancer risk. Int J Cancer 1996; 68: 193-198. Prentice RL, Sheppard L. Dietary fat and cancer: consistency of the epidemiologic data, and disease prevention that may follow from a practical reduction in fat consumption. Cancer Causes Control 1990; 1: 81-97. English DR, Holman CDJ, Milne E, et al. The quantification of drug caused morbidity and mortality in Australia, 1995 edition. Canberra: AGPS, 1995. Willett WC, Trichopoulos D. Nutrition and cancer: a summary of the evidence. Cancer Causes Control 1996; 7: 178-180. Bennett SA, Magnus P. Trends in cardiovascular risk factors in Australia. Results from the National Heart Foundation's Risk Factor Prevalence Study, 1980-1989. Med J Aust 1994; 161: 519-527. Parkin DM, Muir CS, Whelan SL, et al. Cancer incidence in five continents. Vol. VI. Lyon: International Agency for Research on Cancer, 1992. (IARC Scientific Publications No. 120.) Santow G. Trends in contraception and sterilization in Australia. Aust N Z J Obstet Gynaecol 1991; 31: 201-208. Collaborative group on hormonal factors in breast cancer. Breast cancer and hormonal contraceptives: collaborative reanalysis of individual data on 53 297 women with breast cancer and 100 239 women without breast cancer from 54 epidemiological studies. Lancet 1996; 347: 1713-1727. Beral V, Hermon C, Reeves G, et al. Breast cancer trends in women in Sweden, the UK, and the USA in relation to their past use of oral contraceptives. In: Proceedings of the Second International Symposium on Hormonal Carcinogenesis. Berlin: Springer Verlag, 1996: 99-106. dos Santos Silva I, Swerdlow AJ. Recent trends in incidence of and mortality from breast, ovarian and endometrial cancers in England and Wales and their relation to changing fertility and oral contraceptive use. Br J Cancer 1995; 72: 485-492. Snaedal G. Cancer of the breast. A clinical study of treated and untreated patients in Iceland 1911-1955. Acta Chir Scand 1964; Suppl 338. Joensuu H, Toikkanen S. Comparison of breast carcinomas diagnosed in the 1980s with those diagnosed in the 1940s to 1960s. BMJ 1991; 303: 155-158. Buchanan EB. A century of breast cancer surgery. Cancer Invest 1996; 14: 371-377. Kricker A, H¿yer AP, McCredie M, Porter LA. Breast cancer in NSW women: a shift in tumour size. Med J Aust 1995; 163: 79-81. Glasziou PP, Woodward AJ, Mahon CM. Mammographic screening trials for women aged under 50. A quality assessment and meta-analysis. Med J Aust 1995; 162: 625-629. Early Breast Cancer Trialists' Collaborative Group. Systemic treatment of early breast cancer by hormonal, cytotoxic, or immune therapy. Lancet 1992; 339: 1-15. (Received 29 Jan, accepted 21 Jul, 1997) Authors' details National Health and Medical Research Council National Breast Cancer Centre, Sydney, NSW. Catherine L Smith, MPH, Statistician; Anne Kricker, PhD, Epidemiologist. Cancer Control Information Centre, NSW Cancer Council, Sydney, NSW. Bruce K Armstrong, DPhil, FRACP, Director. Reprints will not be available from the authors. Correspondence: Dr A Kricker, NHMRC National Breast Cancer Centre, PO Box 572, Kings Cross, NSW 2011. Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Catherine L Smith · Anne Kricker · Bruce K Armstrong

Mammographic screening in Australia Where are we, and where should we be going? MJA 1997; 167: 516-517 Breast cancer is the commonest cause of cancer death in women in Australia and screening is currently the principal means of reducing this toll. In terms of informing women about screening, the findings of the 1996 National Breast Health Survey, reported in this issue of the Journal by Barratt and colleagues, show that the message is getting through.1 Most women (89%) had heard of the program, 60% nominated mammography without prompting, and most were aware that women over 50 years should be screened every two years. Further, 87% of women aged 50-59 years reported ever having had a mammogram and half reported having been screened within the national program in the last two years. Mammographic screening is now accessible to most Australian women through one of the 36 screening and assessment services that are part of the national program. Community values and target age limits are issues for all cancer screening From a standing start, this is a remarkable achievement in a few years, and a model for what may be required for success in other areas of cancer screening, such as colorectal cancer. There are, however, a number of important policy issues that need to be addressed. The current combined Commonwealth and State funding for the BreastScreen program is of the order of $80 million per year.2 This provides for a 70% uptake of women in the 50-69 years age group plus 40% in the 40-49 years age group. Given the program's good track record, should funds be provided for its improvement or expansion? There are many policy options that can be considered. For example, raising the upper age limit for targeting and reinvitation (currently 69 years), lowering the age limit for targeting (from the current 50 years), reducing the screening interval, or trying to screen more women in the group already targeted. Of these options, the most contentious is the screening of women in the 40-49 years age group. Recently, additional follow-up of the seven randomised trials that included women aged 40-49 years has suggested a delayed benefit not apparent until after at least seven years. A second National Institutes of Health (NIH) consensus conference on the contentious issue of screening women in this younger age group in January this year concluded there was a statistically significant relative mortality reduction of 16% (95% CI, 2%-28%).3 In absolute terms, if there were about 36 deaths per 10 000 women aged 40-49 years, then regular screening "results in the extension of the lives of 0-10 women".3 The number of deaths prevented by screening women aged 40-49 has recently been estimated to be about one-third that in an equivalent number of 50-69-year-old women.4 The consensus panel also pointed out the disadvantages of screening -- false-negative and false-positive mammograms, the psychosocial consequences, and dilemmas such as the detection of ductal carcinomas-in-situ, some of which may never have become invasive. Rather than a blanket recommendation to screen, the consensus panel suggested each woman should decide for herself, but "should have access to the best possible relevant information regarding both benefits and risks, presented in an understandable and useable form". At the subsequent press conference, Dr Richard Klausner, the Director of the National Cancer Institute, stated that he was shocked by the report and announced that it would be reviewed by the National Cancer Advisory Board. Following a United States Senate hearing, the National Cancer Advisory Board voted 17 to one in favour of screening women aged 40-49 years every one to two years. Interestingly, in all this heated debate, no one asked the affected women how they felt about the benefit-harm tradeoff. At a recent Australian National Breast Cancer Centre consensus meeting about screening in 40-49-year-old women, Jill Cockburn (Head, Discipline of Behavioural Science in Relation to Medicine, University of Newcastle, NSW) reported national survey results that showed that most women in this age group felt that the benefits outweighed the risks. However, most also felt they should be given all the information and allowed to make up their own minds rather than there being a blanket recommendation to screen. Enthusiasm for screening also declined when information about the balance between the benefits and disadvantages was given. Similar declines in enthusiasm following receipt of appropriate information have been shown for prostate cancer screening5 and for cholesterol reduction in asymptomatic people.6 In an era of evidence-based practice and tight resources, involving target groups in screening decisions will be vital for formulating rational and acceptable policy. Community values and target age limits are issues for all cancer screening. In general, cancer incidence and mortality continue to rise with age, suggesting we should target older people. However, life expectancy also decreases with age, and the likelihood of dying of other causes before the cancer becomes troublesome increases. Combining the mortality and life expectancy information allows us to calculate age-specific "potential years of life lost"; this is shown for breast cancer in the Figure. There is a steady rise with age, reaching a peak late in the fifth decade, followed by a slow decline. This confirms the appropriateness of the age interval initially chosen by the BreastScreen program, but raises the difficult issue of where we should now draw the line on either side of the peak. This will depend on the balance of benefits and harms as we move away from the peak, and will require input from a representative community sample about their value judgements on the net worth of screening. If this did not give a clear-cut decision, individual informed consent should be required. With such community value judgements and an awareness of the costs, we could make a rational decision about how to best allocate Australia's resources for screening. Paul P Glasziou Reader in Clinical Epidemiology, University of Queensland Les M Irwig Associate Professor of Epidemiology, University of Sydney Barratt AL, Cockburn J, Redman S, Paul C, Perkins J. Mammographic screening: results from the 1996 National Breast Health Survey. Med J Aust 1997; 167: 521-524. Dorsch M. A perspective on the BreastScreen Australia experience. First National Breast Screening Conference; 1997 Aug 21-23; Canberra. Canberra: Commonwealth Department of Human Services and Health, 1997. National Institutes of Health Consensus Development Panel. National Institutes of Health Consensus Development Conference Statement: breast cancer screening for women aged 40-49, January 21-23, 1997. J Natl Cancer Inst 1997; 89: 1015-1026. Irwig L, Glasziou PP, Barratt A, Salkeld G. Review of the evidence about the value of mammographic screening in 40-49-year-old women. Sydney: NHMRC National Breast Cancer Centre, 1997. Flood AB, Wennberg JE, Nease RF, et al. The importance of patient preference in the decision to screen for prostate cancer. J Gen Intern Med 1996; 11: 342-349. Reed WW, Herbers JE, Noel GL. Cholesterol-lowering therapy: what patients expect in return. J Gen Intern Med 1993; 8: 591-596. Kricker A, Jelfs P. Breast cancer in Australian women 1921-1994. Canberra: Australian Institute of Health and Welfare, 1996. (Cancer Series No. 6.) <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia. We appreciate your comments. Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>".

Mammographic screening: results from the 1996 National Breast Health Survey Alexandra L Barratt, Jill Cockburn, Sally Redman, Christine Paul and Janice Perkins For editorial comment, see Glasziou & Irwig This article has been cited in Rodger A, Kavanagh AM, Outcome measures of an Australian breast-screening program, MJA 1998; 169: 179-180 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au>". Abstract - Introduction - Methods - Results - Discussion - References - Authors' details - - - ©MJA1997 Abstract Objective: To establish the extent of women's knowledge of mammographic screening, particularly in relation to the national screening program, BreastScreen Australia, and to estimate the proportion of women who are participating in screening both within and outside BreastScreen Australia. Design and setting: Validated prospective telephone survey of women aged 30-69 years selected at random from across Australia. Participants: 2935 women with no previous breast cancer diagnosis. Results: The adjusted response rate was 64%. Almost 90% of women had heard of the national program; only 1% correctly stated that screening is for asymptomatic women. 60% correctly identified the current recommended age of starting screening is about 50 years of age; 26% thought screening should begin at about 40 years of age. Approximately 60% correctly reported that the recommended screening interval is every two years; 27% thought screening should be done annually. 55% reported ever having had a mammogram, and 37% reported having had at least one screening mammogram. Among women in the target age group (50-69 years) about 70% reported ever having had a screening mammogram, and about 50% reported having had a screening mammogram within the national program in the last two years. Among women aged 40-49 years, 29% reported ever having had a screening mammogram, and 22% reported having been screened in the last two years. Conclusions: Awareness of the national screening program is high, but some women do not know the purpose of screening, the target age group and the recommended screening interval. Compliance with screening is good among women in the target age group; many women in their 40s are also participating in screening. MJA 1997; 167: 521-524 Introduction Breast cancer is the most common cause of cancer death in Australian women, with approximately 7000 new cases and over 2500 deaths annually.1 Evidence from randomised controlled trials shows that mammographic screening can substantially reduce mortality from breast cancer among women aged 50-69 years,2,3 but high rates of compliance with screening are necessary to achieve these benefits. Since 1991 the Commonwealth and State governments have funded a national program of mammographic screening, BreastScreen Australia, which provides free mammographic screening for women aged 40-79 years, but specifically targets women aged 50-69 years. Clearly, if women are to participate, they need to know about mammographic screening generally, and about the service provided by the national program in particular. In 1996, we undertook a national survey on behalf of the National Health and Medical Research Council National Breast Cancer Centre (NBCC) to establish baseline information about women's knowledge of, and participation in, screening mammography. Limited data about participation within the national program are available from the national program's own evaluation reports. Little is known about participation in screening outside the national program. Our aims were, firstly, to determine Australian women's knowledge of mammographic screening and the national program, and whether knowledge differs by area of residence or education. Secondly, we aimed to estimate the proportion of women who are participating in screening both within and outside BreastScreen Australia. Methods The survey was conducted by telephone by a market research company on behalf of the NBCC in April 1996. The questionnaire was developed and pilot-tested by the NBCC; test-retest reliability was assessed by administering the questionnaire twice to a random sample of 100 women at a one-week interval, with good agreement for key items ( k = 0.89-1.00). Telephone numbers were chosen at random from the electronic white pages telephone directory. Up to five callbacks were made to contact eligible women (those aged 30-69 years whose English was sufficient to complete a telephone interview). The sampling frame was stratified to ensure participation by women in all States and Territories, and in urban and rural areas.4 The outcome of every phone call was recorded. Ethical approval for this study was obtained from the NSW Cancer Council Ethics Committee in March 1996. Validation A random sample of 150 women who reported having been screened by BreastScreen Australia were asked for consent to check their questionnaire answers against BreastScreen Australia records. For those who consented, identifying data and the estimated date of last screen within the program were forwarded to BreastScreen Australia for confirmation. To assess selection bias, one survey question (Have you ever had a mammogram?) was placed in the February 1996 Australian Bureau of Statistics (ABS) Population Survey Monitor, which is conducted quarterly by household interview. The question was asked only of women 30-69 years in the ABS sample, and the results were weighted as for our survey (described below) to give a comparable estimate. Statistical analysis Our data were weighted for area of residence and age based on ABS projected population estimates. As all percentages reported in this paper are weighted results, sample sizes are not routinely given in the results. Significance testing was done by chi-squared tests based on the sample size of the survey; P values of less than 0.05 were considered statistically significant. Ninety-five per cent confidence intervals were calculated from the standard error of the proportion, again based on the sample size of the survey. Education was coded according to ABS categories and collapsed to those with post-school qualifications and those without post-school qualifications.5 Age was classified as younger (30-49 years) and older (50-69 years) to differentiate women within and outside the target age range of the national program. Results The raw response rate was 70.2% (calculated as completed interviews [3014] over contacted eligible women [4291]). After inflating the denominator by the estimated number of eligible women among those who could not be contacted (n = 389), the response rate was 64.4%. Seventy-nine women who had previously been diagnosed with breast cancer were excluded. The demographic characteristics of the remaining women are shown in Box 1. Of the 150 women asked, 127 (85%) consented to having their screening records checked. Of 126 women who reported having been screened within BreastScreen Australia within the last two years, attendance was confirmed for 121 (96%). Twenty-six per cent of women were able to recall the mammogram date accurately to the day, and a further 38% accurately recalled the month. Ninety-two per cent of women reported the mammogram date accurately to within 12 months. The weighted ABS estimate for the question Have you ever had a mammogram? was 50% (95% CI, 46.9-53.2). Responses to specific questions Do you know any ways to detect breast cancer in the early stages? -- 63.2% of respondents nominated mammography without prompting. Those more likely to nominate mammography were older women (chi-squared = 14.99; P < 0.01) and women with post-school qualifications (chi-squared = 12.05; P< 0.01). The Commonwealth and State governments fund a mammographic screening program in Australia known as the National Program for the Early Detection of Breast Cancer. In [respondent's State] it is known as [program name in respondent's State] . Have you heard of this Program? -- 88.7% of women responded that they had heard of the national program. More women in rural areas than in urban areas had heard of the program (92.9% v. 87.0%; chi-squared = 14.82; P< 0.001). More older than younger women had heard of the program (93.1% v. 86.2%; chi-squared = 42.09; P< 0.001). There was no difference in the proportion who had heard of the program by educational level. Which women do you think should attend for mammographic screening; only women who have no symptoms of breast cancer ; only women who have symptoms of breast cancer ; or it doesn't matter whether women have symptoms or not? -- only 1.3% of women correctly replied that screening was for women without symptoms, 2.9% replied that it was for women with symptoms, and 94.8% replied that it didn't matter. Slightly more younger women than older women thought screening was for women with symptoms (3.6% v. 2.0%; chi-squared = 11.70; P< 0.009). There were no differences between women living in urban and rural areas or according to educational level. When does the government program recommend women should start (stop) having mammograms? -- 60.3% of women correctly reported that the recommended commencement age was 50-59 years; 26.0% reported it was 40-49 years (see Box 2). More younger women than older women reported that the recommended commencement age was 40-49 years (28.1% v. 22.5%; chi-squared = 58.73; P= 0.001). Again, there were no differences in these proportions between women living in urban and rural areas or according to educational level. Most women (55.5%) thought screening should never cease, and 19.5% of women were unable to say when screening should stop (Box 2). How often does the government screening program suggest women should have a screening mammogram? -- 58.7% correctly reported that the government program suggests screening should be done every two years, but 26.7% reported that annual screening is recommended. More younger women than older women reported that annual screening is recommended (32.1% v. 17.4%; chi-squared = 178.76; P< 0.001). Referral and access to the government program Of respondents in the target age group (50-69 years), 34.7% reported that their GP had suggested they have a mammogram as part of the government program. This proportion did not vary by area of residence or by education level. Among all respondents, almost all women (95.8%) reported having visited a GP within the last two years. Among women in the target age group, 84.0% knew that a screening mammogram within the national program was free. More women with post-school qualifications knew this (87.9% v. 80.9%; chi-squared = 9.30; P= 0.01), but the proportions did not vary according to area of residence. Most women in the target age group (65.8%) reported being very confident of knowing how to make an appointment for a mammogram within the program, and this proportion did not differ according to area of residence or educational level. Participation in screening mammography A series of questions was used to determine whether women had had a mammogram within or outside the national program. To determine whether it had been a screening mammogram, they were then asked, When you had [that mammogram] was it because you already thought you had some problems with your breasts?. Overall, 55.0% of all women reported ever having had a mammogram (Box 3). The frequency of having had a mammogram rose steeply with age, peaking in the 50-59 years age group at 86.5%. Overall, 36.6% of women reported having had at least one screening mammogram (Box 3). Among women aged 30-39 years, approximately 6% reported having been screened, and this proportion rose to approximately 70% in the 50-69 years target age group. Having had a screening mammogram was not associated with area of residence or with education. In the target age group (50-69 years), 49.5% of women reported being screened in the national program within the last two years, and this was not influenced by area of residence or educational level. Another 12.1% reported having been screened outside the national program within the last two years. Among women 30-39 years of age, only 3% had been screened in the last two years, mostly outside the national program. In the older age groups, most women reported being screened within the national program (Box 4). Discussion Our findings are the first validated, baseline estimates of Australian women's knowledge of, and participation in, mammographic screening since the establishment of the national program. Our adjusted response rate of 64% compares well with those of similar reported surveys.6-8 The estimate by the ABS for the identical question Have you ever had a mammogram? was 50% (95% CI, 46.9-53.2) compared with ours of 55% (95% CI, 53.2-56.8), suggesting that our estimates are likely to be only minimally affected by selection bias. However, we excluded some women, notably non-English speakers and those living in homes without telephones. Also, as it is likely that women who chose to participate were more aware of breast cancer and screening mammography than those who refused, our data may overestimate both women's knowledge of, and participation in, such screening. Awareness of the national program was high (nearly 90%). Although asking a prompted question may have inflated this estimate, the result does suggest that the promotion of the program has been effective. The vast majority of women knew that the national program is free, and that it recommends women start screening at around 50 years of age and have a screening mammogram every two years. Most women also felt very confident in knowing how to access the program. The absence of significant variation in knowledge about screening mammography according to area of residence or educational level suggests that the national program has been successful in widely promoting screening. However, consistent with a previous study,9 most women were not aware that screening is intended only for asymptomatic women. Most women thought symptoms didn't matter, suggesting they appreciate to some extent that the national program is not designed for the evaluation of symptoms. While this may be encouraging, it is still of some concern as people who do not appreciate the distinction between diagnostic and screening tests may be more likely to seek compensation for missed diagnoses.9 As most women reported that their GPs had never recommended they attend the national program for screening, there is a greater opportunity for GPs to recruit more women to screening. Our findings indicate that attendance for mammography is becoming increasingly common. Surveys conducted in 1988 found that only 18% of women spontaneously mentioned mammography as a means of detecting breast cancer in the early stages, and 50% claimed to have heard of it when prompted.10 Only about 10%-20% of women had ever had a mammogram, about half for diagnostic and half for screening purposes.7,11 Clearly, this situation has changed dramatically, with 60% of women now nominating mammography as a means of early detection in an unprompted question, 55% of all women reporting having ever had a mammogram, and 37% of women reporting having had at least one screening mammogram. High proportions of women in the age group targeted by the national program reported having been screened at least once (70%) and having been screened in the last two years (about 60%). Many more of these women are being screened as part of the national program than outside it. Our finding that 49.8% of women in the target age group had been screened within the national program in the last two years is consistent with BreastScreen Victoria's estimated participation rate of 47.7%.12 Recent meta-analyses showing a small reduction in mortality after about 10 years of screening for women aged 40-49 years13 have prompted heated debate over whether younger women should also be targeted for screening. It is interesting to note that we found quite high screening rates among women aged 40-49 years, indicating that many women in this age group are, in fact, already being screened. References Taylor R, Smith D, Hoyer A, et al. Breast Cancer in New South Wales 1972-1991. Sydney: NSW Cancer Council, 1994. Kerlikowske K, Grady D, Rubin SM, et al. Efficacy of screening mammography. A meta-analysis. JAMA 1995; 273: 149-154. Glasziou P, Woodward AJ, Mahon CM. Mammographic screening trials for women aged under 50. A quality assessment and meta-analysis. Med J Aust 1995; 162: 625-629. Department of Primary Industries and Energy, Department of Human Services and Health. Rural, remote and metropolitan areas classification. Canberra: AGPS, 1994. Australian Bureau of Statistics. Labour force status and educational attainment, Australia. Canberra: Australian Bureau of Statistics, 1994. (Catalogue No. 6235.0.) Etzi S, Lane DS, Grimson R. The use of mammography vans by low-income women: the accuracy of self-reports. Am J Public Health 1994; 84: 107-109. Hill D, White V, Borland R, Cockburn J. Cancer-related beliefs and behaviours in Australia. Aust J Public Health 1991; 15: 14-23. Smith W, Chey T, Jalaludin B, et al. Increasing response rates in telephone surveys: a randomized trial. J Public Health Med 1995; 17: 33-38. Cockburn J, Redman S, Hill D, Henry E. Public understanding of medical screening. J Med Screening 1995; 2: 224-227. Cockburn J, Murphy B, Schofield P, et al. Development of a strategy to encourage attendance at screening mammography. Health Ed Res Theory Practice 1991; 6: 279-290. Irwig L, Cockburn J, Turnbull D, et al. Women's perceptions of screening mammography. Aust J Public Health 1991; 15: 24-32. BreastScreen Victoria: 1995 annual statistical report. Melbourne: BreastScreen Co-ordination Unit, 1996. Breast-cancer screening with mammography in women aged 40-49 years. Report of the Organizing Committee and Collaborators, Falun Meeting, Falun, Sweden 1996. Int J Cancer 1997; 68: 693-699. (Received 11 Mar, accepted 12 Aug, 1997) Authors' details Department of Public Health and Community Medicine, University of Sydney, NSW. Alexandra L Barratt, PhD, FAFPHM, Lecturer. Discipline of Behavioural Science in Relation to Medicine, University of Newcastle, NSW. Jill Cockburn, PhD, Head. National Health and Medical Research Council National Breast Cancer Centre, Sydney, NSW. Sally Redman, PhD, Director; Christine Paul, PhD, Consultant Behavioural Scientist. New South Wales Cancer Council Cancer Education Research Program, Wallsend, NSW. Janice Perkins, PhD, Research Associate. Currently at the Discipline of Behavioural Science in Relation to Medicine, University of Newcastle, NSW. No reprints will be available. Correspondence: Dr A L Barratt, Department of Public Health and Community Medicine, Building A27, University of Sydney, NSW 2006. - ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Local impact of the NHMRC early breast cancer guidelines: where to from here? Jeanette E Ward, John Boyages and Leena Gupta Subsequently cited in Dwyer P. Legal implications of clinical practice guidelines. MJA 1998; 169: 292-293. Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". Abstract - Introduction - Methods - Results - Sample characteristics - Recall of and reactions to the guidelines - Self-reported use and views of impact on clinical practice and patient outcomes - Discussion - Acknowledgements - References - - ©MJA1997 Abstract Obj ectives: To determine clinicians' recall of the National Health and Medical Research Council's (NHMRC) Clinical practice guidelines for the management of early breast cancer six months after publication, and their reactions to its content and potential dissemination and implementation strategies. Setting: Greater Western Region of Sydney, May 1996. Method: Self-administered survey of clinicians with an involvement or interest in the management of women with breast cancer. Results: Of the 69 respondents to the questionnaire (77% response rate), 20% did not recall ever seeing the guidelines. Although most agreed with the defined parameters of potential strengths of the guidelines, there was less agreement as to their medicolegal implications. The four treatment sections of the guidelines were the most highly rated, followed by the sections on communication skills and investigations. Education programs, including college-based programs, as well as endorsement of the guidelines by the learned colleges and respected colleagues, were rated highly as dissemination strategies, far outranking Internet availability. Local revision of the guidelines was considered important as an implementation strategy by three-quarters of respondents. Only 20% indicated that the guidelines had influenced clinical practice, although 46% agreed that they would improve outcomes for women with early breast cancer. Conclusions: The NHMRC early breast cancer guidelines have been relatively well received in the Greater Western Region of Sydney, although local activities within public institutions and private practice will be needed to achieve implementation . MJA 1997; 167: 362-365 Introduction Evidence-based clinical guidelines have been advocated by overseas1-3 and local4 authorities to support more effective health care and enhance patient outcomes. However, publication of guidelines alone is insufficient to ensure improvements in clinical practice because dissemination and implementation of guidelines must follow if patient outcomes are to improve.5 Although there is evidence of increased activity in the development of evidence-based guidelines in Australia, dissemination and implementation of such guidelines have received less emphasis.6 Dissemination refers to activities which encourage positive attitudes toward specific guidelines and raise awareness of the need to change. Strategies appropriate to disseminate guidelines include medical seminars about the guidelines and endorsement by recognised peers.7 Implementation refers to activities which aim to achieve and maintain changes in actual practice. Strategies to implement guidelines include audit and feedback, prompts for clinicians, checklists for patients, and financial sanctions and incentives.7,8 The Clinical practice guidelines for the management of early breast cancer9 were the first guidelines produced by the National Health and Medical Research Council (NHMRC) using an explicit evidence-based process.10 The guidelines, published in 1995, were designed "to assist in decision-making by women and their doctors, educate all involved in the care of women with breast cancer, assess and assure the quality of care, reduce the risk of legal liability by improving care and bring the issue of cost-effectiveness into the public arena".10 A consumer guide was also published at the same time.11 We wished to determine clinicians' recall of the guidelines six months after national distribution as well as their reactions to its content, and potential dissemination and implementation strategies. Methods In May 1996, we mailed an eight-page questionnaire and a copy of the guidelines, after an advance telephone prompt, to all members of the Western Areas Breast Group in the Greater Western Region of Sydney, encompassing the Western, Wentworth and Southwestern area health services (n = 52), all other clinicians known to have managed women with breast cancer in 1992 in the region12 (n = 27), and surgical and oncology registrars (n = 11). Non-respondents were followed up with reminder letters a fortnight later and a telephone call 26 days later by one of us (J E W) and 70 days later by an eminent peer. The questionnaire was designed to assess recall and recent use of both the guidelines and consumer guide and the impact of the guidelines to date. We asked respondents to rate eight potential strengths of the guidelines and seven potential criticisms using a five-point scale (strongly agree, agree, unsure, disagree, strongly disagree). To assess content relevance, we asked respondents to rate the usefulness of information in 12 sections of the guidelines using five categories (very, somewhat useful, not useful, unsure, not applicable). To assess the influences on clinicians' decisions whether to follow the guidelines, we asked respondents (using the same response options) to rate the relative importance of each of four features of the development process, one current and five potential dissemination strategies, and three implementation strategies. The latter consisted of a regional implementation strategy designed around revision of the guidelines by all western Sydney specialists to enhance its local application as well as two other implementation strategies drawn from the international literature7,8 (namely, an interactive computerised system to provide clinicians with individualised feedback about patterns of care, and patient checklists provided directly to women). Eight questions ascertained respondents' sociodemographic and professional characteristics. Results Sample characteristics We obtained a 77% response rate (90 clinicians received questionnaires and 69 returned them). Of the 69 respondents, 59 (85%) were men and 10 were women (14%), and ages ranged from 26-67 years. The sample consisted of 35 general surgeons (51%), 10 breast surgeons (14%), five medical oncologists (7%), seven radiation oncologists (10%), and nine registrars (13%) (a further three did not specify). The number of new patients with breast cancer seen per respondent per month ranged from 0-20 (mode, 1; median, 2). Involvement in teaching and research was reported by 52 (75%) and 29 (42%), respectively. Over half the respondents had Visiting Medical Officer appointments (n = 39; 56%), and 18 (26%) were full-time staff specialists in public hospitals. Eight breast surgeons (80%) and 16 general surgeons (46%) were associated with the Royal Australasian College of Surgeons Breast Section. Recall of and reactions to the guidelines Fifty-five respondents (80%) indicated they had seen the guidelines before receiving a copy with our survey, while 12 (17%) had commented on the earlier draft circulated for consultation in June 1995. Only 35 (51%) were aware of the Consensus Statement on the Management of Breast Cancer, published by the Clinical Oncological Society of Australia.13 Fifty-one respondents (74%) were familiar with the consumer guide, but only 12 (17%) always recommended it to women; 20 (29%) sometimes and five (7%) rarely. A further 25 (36%) did not recommend it at all. Of the 37 who recommended the consumer companion, only two would document this always in their medical records; two sometimes and one rarely. The rest never recorded it. Box 1 shows that at least three-quarters of respondents had positive views (strongly agree or agree) for five out of eight statements about potential strengths of the guidelines. More than half disagreed or strongly disagreed with five of seven potential criticisms of the guidelines. While 32% were unsure if the guidelines could be used to sue doctors, 45% agreed or strongly agreed that they could. Box 2 summarises respondents' ratings of specific sections of the guidelines. The four sections listed in the questionnaire about treatment decisions were the most highly rated, followed by the section on communication skills, which outranked the seven sections concerning investigations and other pretreatment decisions. All four features of the guidelines development process were very or somewhat important for almost all of the respondents in deciding whether to follow their recommendations (Box 3). To disseminate the guidelines, most respondents rated educational programs conducted by learned colleges (84%) as well as their endorsement of the guidelines (86%) as very or somewhat important strategies. Other educational programs and recommendation by a respected colleague were rated as very or somewhat important by nearly three-quarters of respondents and outranked Internet availability (the only dissemination strategy in place at the time of the survey). To implement the guidelines, local revision by specialists to make the guidelines more practical was ranked by 76% as being either very or somewhat important in deciding whether to follow the guidelines, contrasting with respondents' ratings of an interactive computer system (50%) and patient checklists (34%). Self-reported use and views of impact on clinical practice and patient outcomes Forty-one (59%) respondents had not referred to the guidelines at all in the previous month of practice, 20 (29%) had referred to them between one and four times, and seven (10%) more than four times. Of the 38 respondents who indicated they saw at least one new patient each month, 34 (90%) had not referred to the guidelines at all in the previous month. Forty-two (61%) respondents indicated that the guidelines had had no influence on their clinical practice, 14 (20%) indicated that they had, and three (4%) were unsure (data missing or the guidelines had not been seen by the remainder). In response to the question Will the guidelines improve outcomes for women with early breast cancer?, 32 (46%) indicated "yes", while 11 (16%) indicated "no", and 25 (36%) were unsure. Discussion Our study assessed the initial reactions of a multidisciplinary group of clinicians to the first evidence-based clinical practice guidelines produced by the NHMRC. Most respondents (80%) had seen the guidelines six months after publication. This compares well against previous surveys showing much lower recall of other national guidelines (e.g., among general practitioners),14 and exceeds the proportion recalling earlier guidelines produced by the Clinical Oncological Society of Australia.13 Even clinicians who recalled the guidelines appear not to have been substantially influenced by them. However, it is possible that clinical practice was already consistent with evidence-based best practice. However, this explanation is inconsistent with the fundamental premise underpinning initiation of the guidelines9 and other, indirect, evidence of an unacceptable variation in practice.12,15 In addition, the guidelines (and a parliamentary report16 ) recommend that clinicians advise their patients about the availability of the consumer companion and recommend them as a reference to be used in cooperation with their doctor.9 However, more than a third of respondents did not recommend the consumer guide at all. Guidelines will not change practice unless clinicians have access to them when needed. Our study shows that use of the guidelines at the local level appears limited. A planned approach to dissemination and implementation is needed. Respondents' ratings of potential strategies have identified useful priorities. Their views on potential dissemination strategies ought to be used to find ways to encourage positive attitudes toward the guidelines and, through their preferred implementation strategies, to change behaviour. Respondents' interest in educational programs conducted by learned colleges, as well as colleges' endorsement of the guidelines, suggests the use of these strategies to create a greater interest in the guidelines. To achieve full implementation, however, local adaptation will be critical.18 Local adaptation will engender a stronger sense of ownership of the guidelines, but mechanisms to enssure the methodological integrity of the evidence-based elements of the guidelines throughout the process of local adaptation will need to be developed. As implementation strategies shown to be effective in overseas research received low ratings in our survey, they should be replicated in controlled trials before being given wider advocacy. Given the relative lack of experience in Australia to date in disseminating, implementing and monitoring use of evidence-based guidelines,17 documentation of the process of local implementation of the guidelines is needed. Finally, as measurement of improved patient outcomes represents the "gold standard" of guidelines evaluation,4,19 we recommend such an approach at local, State and national levels. Acknowledgements We thank all who completed the questionnaire; Professor Allan Langlands and staff of the Breast Cancer Institute for commenting on draft questionnaires; Dr Kate George for telephone prompts; Ms Josette Banks and Mrs Nancy Harding for survey administration; Emeritus Professor Tom Reeve for generous contribution to telephone follow-up; and Mr Md Moniruzzaman for data analysis. References Field M, Lohr K. Guidelines for clinical practice: from development to use. Washington: National Academy Press, 1992. Grimshaw J, Russell I. Achieving health gain through clinical guidelines: 1. Developing scientifically valid guidelines. Qual Hlth Care 1993; 2: 2432-2438. Hayward RSA, Laupacis A. Initiating, conducting and maintaining guidelines development programs. Can Med Assoc J 1993; 148: 507-512. National Health & Medical Research Council. Guidelines for the development and implementation of clinical practice guidelines. Canberra: AGPS, October 1995. Grimshaw J, Russell I. Achieving health gain through clinical guidelines II: ensuring guidelines change medical practice. Qual Hlth Care 1994; 3: 45-52 Holt P, Wilson A, Ward J. Clinical practice guidelines and critical pathways: a status report on national and NSW development and implementation activity. Sydney: NSW Health Department, 1996: 106. Grimshaw J, Russell I. Effect of guidelines on medical practice: a systematic review of rigorous evaluations. Lancet 1993; 342: 1317-1322. Davis D, Thomson M, Oxman A, Haynes RB. Changing physician performance: a systematic review of the effect of CME. JAMA 1995; 274: 700-705. National Health and Medical Research Council. Clinical practice guidelines for the management of early breast cancer. Canberra: AGPS, 1995. Smallwood R. President's letter. RACP Fellowship Affairs 1996; 15: 3. National Health and Medical Research Council. Early breast cancer. A consumer's guide. Canberra: AGPS, 1995. Western Areas Breast Group. Breast cancer patterns of care in the Greater Western Region of Sydney in 1992. Sydney: NSW Breast Cancer Institute, 1997: 1-98. Breast Cancer Consensus Report. Med J Aust 1994; 161 (Suppl): S1-S16. Gupta L, Ward J, Hayward R. Clinical practice guidelines in general practice: a national survey of recall, attitudes and impact. Med J Aust 1997; 166: 69-72. Adelson P, Lim K, Churches T, Nguyen R. Surgical treatment of breast cancer in NSW, 1991-1992. Aust N Z J Surg 1997; 67: 9-14. 16. House of Representatives Standing Committee on Community Affairs. Report on the management and treatment of breast cancer in Australia. Canberra: AGPS, February 1995: 133. Ward J. Best practice guidelines implementation -- implications for patient outcomes. Proceedings of the Second Conference of the Australian Health Outcomes Clearing House. Integrating health outcomes measurement in routine health care; 1996 Aug 13-14; Canberra. Canberra: AHOCH, 1997: 78-83. Browman G, Levine M, Mohide E, et al. The practice guidelines development cycle: a conceptual tool for practice guidelines development and implementation. J Clin Oncol 1995; 13: 502-512. Thompson R, Lavender M, Madhok R. How to ensure that guidelines are effective. BMJ 1995; 311: 237-242. (Received 8 Jan, accepted 3 July, 1997) Author's Details Needs Assessment & Health Outcomes Unit, Central Sydney Area Health Service, NSW. Jeanette E Ward, PhD, FAFPHM, Director; Leena Gupta, MPH, FAFPHM; formerly, Clinical Epidemiologist (Cancer Outcomes). NSW Breast Cancer Institute, Western Sydney Area Health Service, NSW. John Boyages, FRACR, PhD, Director. Reprints: Dr J E Ward, Needs Assessment & Health Outcomes Unit, Central Sydney Area Health Service, Locked Bag 8, Newtown, NSW 2042. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Jeanette E Ward · John Boyages · Leena Gupta

Patient preference and prostate cancer screening Fully informed men should be free to exercise their personal preference regarding screening MJA 1997; 167: 240-241 Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". - ©MJA1997 Every year in Australia it is estimated that more than 2500 men die of disseminated prostate cancer and many more suffer the consequences of advanced metastatic disease.1 In New South Wales in 1994, the chance of men in the age group 0-74 years developing clinically apparent prostate cancer was 13.2% (2908 new prostate cancer cases were reported in men aged 45-74 years).2 However, because of ageing of the Australian population (many men live beyond 74 years of age) the lifetime risk is actually considerably higher. The use of prostate specific antigen (PSA) screening for early detection of prostate cancer has been the subject of considerable debate. The screening may be of the general population, or limited screening of "at risk" populations, or, finally, case finding, with the screening being part of a routine medical check-up. Currently, for all three types of screening there are no randomised trials to determine whether PSA screening does more good than harm, or the converse. In particular, there is little evidence to support general population screening.3 In the current climate of uncertainty, it is mandatory to include the patient in any screening decision. What is the stance of national professional bodies in the face of this uncertainty? The American Cancer Society recommends annual PSA testing starting at age 50 for men with average risk for prostate cancer.4 Their guidelines, however, are not recommendations for public programs of mass screening, but are intended to help individual doctors and patients select the best early detection protocol for their personal needs. The American Urological Association also recommends annual screening with both digital rectal examination and PSA for men aged 50-70 years.5 On the other hand, the US Preventive Services Task Force recommends against screening,6 and in Europe the consensus is that widespread population screening cannot be recommended as a public health policy at present.7 What are the recommendations in Australia? The Australian Cancer Society8 and the Australian Health Technology Advisory Committee3 recommend against screening.4 The Urological Society of Australasia's current position is to recommend against population screening of asymptomatic men. However, they recommend that asymptomatic men aged 50-70 years (or between 40 and 70 years with a positive family history of the disease) who wish to be tested should be able to do so after appropriate counselling. They suggest that it is up to individual doctors to decide whether to advocate screening for a man not requesting it.9 What are the arguments for and against screening? Those in favour of screening argue that even small tumours will eventually progress to metastatic disease if the patient lives long enough.10 In addition, most cancers detected by PSA-based screening are largely cancers expected from their volume and histological grade to progress.11 There is also strong evidence to suggest that disease confined to the prostate is curable.12 Furthermore, a recent population study with long term follow-up of almost 60 000 patients with clinically localised prostate cancer provided evidence that treatment in moderate and poorly differentiated tumours is superior to observation alone.13 Finally, PSA will detect organ-confined disease, and therefore potentially curable cancer, more frequently than digital rectal examination alone.11 Critics of screening contend that the sensitivity and specificity of PSA screening are too low to make it an ideal screening test. Furthermore, only one cancer will be found for every three men having a biopsy after a PSA-positive test result.11 This leaves a proportion of patients with the stress of being PSA positive and biopsy negative, until it is ultimately discovered whether the PSA test result is a false positive or the biopsy result a false negative. Furthermore, the potential for slow non-life-threatening growth of untreated prostate cancer, particularly in the older age group, means that more men will die with prostate cancer than of it, not to mention the morbidity and mortality associated with the biopsy and the treatment.14 In this climate of uncertainty what are our general practitioners (GPs) doing? The Royal Australian College of General Practitioners recommends against screening.15 However, in a recent questionnaire survey of New Zealand GPs, most indicated that they currently screen at least some men aged 50 or more by digital rectal examination or PSA regardless of beliefs about test efficacy.16 This is probably explained by GPs' direct clinical responsibility and their greater concern with their patients' individual needs rather than with recommendations of public health and professional bodies. What then is the community perspective? In this issue of the Journal, Ward et al. address the subject of male awareness of prostate cancer.17 In a randomly selected group of 340 men aged between 40 and 80, they showed that 22% of those aged 50 or more had been screened for prostate cancer within the previous 12 months. They also found that the men in this population overestimated their lifetime risk of developing and dying of prostate cancer. This is no doubt due in part to the widespread incidence of the disease, as well as a general fear of cancer and raised awareness resulting from increased media coverage. From a public health viewpoint, the significant cost of prostate cancer screening would need to be offset by pos sible cost savings from an eventual mortality rate decrease. From an individual viewpoint, the detection of an asymptomatic organ-confined cancer (case finding) may be of substantial benefit. While the international medical community remain divided on this issue, and there is evidence for and against case finding, we believe that each man must participate in the screening decision and decide for himself. This decision is complex and must be made with full knowledge of the risks of contracting and dying from prostate cancer. The decision will be affected by the man's age and general health, and his particular risk category for developing prostate cancer. The opinions of his general practitioner and even the wishes of his spouse will affect his decision. He must be aware of the potential side effects of diagnosis and treatment, and understand that, in conservatively managed patients, if hormone therapy fails there is no further reliably effective treatment. Ward et al. have shown that screening is occurring in the community, and they argue that accurate information is not being received by the community at large. They recommend that public health initiatives to discourage prostate cancer screening should focus particularly on men with bothersome urinary symptoms and those who worry about prostate cancer.17 While we agree that public education is essential, we believe this must neither discourage nor encourage screening by case finding, but rather give accurate, unbiased information to all men. The information must be balanced, as it has now been shown in several studies that patient preference regarding screening and treatment is greatly affected by this information.18 In the current climate of uncertainty, it is mandatory to include the patient in any screening decision. This is the recommendation of the Australian Health Technology Advisory Committee3 and the Urological Society of Australasia.9 When fully informed, men should be free to exercise personal preference regarding prostate cancer screening. Phillip D Stricker Urologist, St Vincent's Clinic, Sydney, NSW David R Eisinger Urologist, Concord Hospital, Sydney, NSW Australian Bureau of Statistics. Causes of death, Australian, 1994. Canberra: ABS, 1995. (Catalogue No. 3303.0.) Coates MS, Armstrong BK. Cancer in New South Wales. Incidence and mortality, 1994. Sydney, NSW Cancer Council, June 1997. Australian Health Technology Advisory Committee. Prostate cancer screening. Canberra: AGPS, 1996. Mettlin CJ, Jones GW, Avarette H, et al. Defining and updating the American Cancer Society guidelines for the cancer related checkup; prostate and endometrial cancer. CA Cancer J Clin 1993; 43: 42-46. American Urological Association Policy Statement on early detection of prostate cancer. Am Urol Assoc Today 1994; 7: 16. US Preventive Services Task Force. Screening for prostate cancer. Guide to clinical preventive services. 2nd ed. Baltimore, Md: Williams & Wilkins, 1996: 119-134. Flemish Advisory Committee on Cancer Prevention, Belgium. Report of the consensus workshop on screening and global strategy for prostate cancer. Denis LJ, Murphy GP, Schroder FH, editors. Cancer 1995; 75: 1187-1207. Australian Cancer Society. Prostate cancer screening: guidelines for health professionals. Cancer Forum 1995; 19: 47-50. Urological Society of Australasia. Prostate screening, a personal choice: surgeons. Media release, 27 August, 1996. Hugosson J, Aus E, Bergdahl D, et al. Prostate cancer mortality in patients surviving more than 10 years after diagnosis. J Urol 1995; 154: 2115-2117. Catalona WJ, Richie HP, Ahmann FR, et al. Comparison of digital rectal examination and serum PSA in the early detection of prostate cancer: results of a multicenter clinical trial of 6,630 men. J Urol 1994; 151: 1283-1290. Walsh PC, Partin AW, Epstein JI. Cancer control and quality of life following anatomical radical retropubic prostatectomy: results at 10 years. J Urol 1994; 152: 1831-1836. Lu-Yao GL, Yao Siu-Long. Population-based study of longterm survival in patients with clinically localised prostate cancer. Lancet 1997; 349: 906-910. Hirst GHL, Ward JE, Del Mar CB. Screening for prostate cancer: the case against. Med J Aust 1996; 164: 285-288. Royal Australian College of General Practitioners. Preventive and Community Medicine Committee. Kable B, chair. Guidelines for preventive activities in general practice. 3rd ed. Sydney: RACGP, Oct 1996. Morris J, McNoe B, Adam H. Screening for prostate cancer: what do general practitioners think? N Z Med J 1997; 110: 178-182. Ward JE, Hughes AM, Hirst GHL, Winchester L. Men's estimates of prostate cancer and self-reported rates of screening. Med J Aust 1997; 167: 250-253. Flood AB, Wennberg JE, Nease RF Jr, et al. The importance of patient preference in the decision to screen for prostate cancer. J Gen Intern Med 1996; 11: 342-349. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Phillip D Stricker · David R Eisinger

Men's estimates of prostate cancer risk and self-reported rates of screening Jeanette E Ward, Ann-Maree Hughes, Geoffrey H L Hirst and Lorraine Winchester For editorial comment, see Stricker & Eisinger Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". Abstract - Introduction - Methods - Results - Discussion - Acknowledgements - References - Authors' details - ©MJA1997 Abstract Objective: To determine rates of prostate cancer screening and predictors of men's participation in this screening in the light of national recommendations against prostate cancer screening. Design: Community-based study (computer-assisted telephone survey). Setting: Central Sydney Area Health Service. Participants: Randomly selected men aged 40-80 years. Results: 340 men participated (65% response rate). While the true lifetime (0-74 years) risk of developing or dying from prostate cancer is reported to be one in 18 (6%) and one in 65 (1.5%), respectively, 37% of respondents thought that at least one in five men (20%) would develop prostate cancer before the age of 75 years and 11% that one in five (20%) would die from it. Twenty-two per cent of men aged 50 years or over had been screened for prostate cancer within the previous 12 months. Ever worrying about prostate cancer and bothersome urinary symptoms independently predicted the probability of screening within the previous year. Sociodemographic characteristics such as age, occupation and country of birth were not associated with screening. Conclusions: Public health initiatives to discourage prostate cancer screening should focus particularly on men with bothersome urinary symptoms and those who worry about prostate cancer. Accurate information about the low risks of dying from prostate cancer needs to be communicated, and the speculative nature of current evidence in support of screening as a means of reducing this risk should be emphasised. MJA 1997; 167: 250-253 Introduction Despite repeated advice to the contrary, screening for prostate cancer is being requested by patients and conducted by doctors. Advice against screening has come from a policy statement for health professionals released in 1995 by the Australian Cancer Society,1 and a 1996 report of a multidisciplinary committee convened by the Australian Health Technology Advisory Committee on the basis that the evidence did not meet accepted criteria for benefits, risks and costs.2 In addition, the National Health and Medical Research Council (NHMRC) evidence-based guidelines for the management of men with uncomplicated lower urinary tract symptoms (LUTS)3 state that there is no evidence that prostate specific antigen (PSA) tests are required for men with uncomplicated LUTS as men with these symptoms are at no greater risk of prostate cancer than asymptomatic men.4 Data indicating that screening is occurring come from the Department of Veterans' Affairs,5 as well as surveys of urologists6 and general practitioners (unpublished data). In describing this "conundrum", Horner identified a pressing need for research to support educational programs for men, focusing on "strategies to combat uninformed patient demand".7 While the Australian Health Technology Advisory Committee guidelines advocate national action involving the NHMRC,2 the need for health services to intervene actively at a local level to discourage prostate cancer screening has also been recognised in New South Wales.8 In the absence of more recent data, we used the opportunity of a large population-based study about men's health to determine the prevalence and predictors of participation in screening for prostate cancer in the area defined by the Central Sydney Area Health Service. Methods The study was approved by the Royal Prince Alfred Hospital Ethics Review Committee. Community sampling Two thousand names, addresses and telephone numbers within the 35 postcodes constituting the Central Sydney area were randomly selected from the Electronic White Pages.9 To maximise participation rates, each household received a one-page letter outlining the Men's Health Study and anticipating telephone contact, supported by a media release to further publicise the study. The initial sample size of 2000 was estimated to be sufficient to provide between 250-350 completed surveys given an estimated prevalence of 38%10 of eligible male respondents in contacted households and a conservative consent rate. Computer-assisted telephone interview survey A market research company with computer-assisted telephone interview facilities contacted all 2000 households between 26 November and 12 December 1996 on weekdays between 1500 and 2100. Where the first contact was unsuccessful, a further five attempts were made at different times and on different days. Men aged between 40 and 80 years residing in the household and fluent in English were eligible to participate. If there was more than one man in the household meeting these criteria, the one with the most recent birthday was asked to participate. Due to the sensitive nature of the survey, all telephone interviewers were mature females with previous experience in conducting health-related surveys. A briefing session for interviewers was conducted to address potential difficulties with medical jargon, to ensure sensitivity towards the issues and to standardise the interviews. Survey instrument At the beginning of the interview, respondents were asked standard sociodemographic questions, as well as whether they had ever been diagnosed with a urological condition and questions modified from the International Prostate Symptom Score11 to assess the presence of and degree of "bother" attributable to urinary symptoms. We then asked respondents five questions about prostate cancer. 1. "Have you ever worried that you might have prostate cancer?" Those answering "yes" were asked "For what reasons?". 2. "Have you had any test to detect prostate cancer in the last 12 months?" Those answering "yes" were asked to name the test(s). 3. "Have you heard of any tests for prostate cancer?" 4. "Out of 100 Australian men, how many or what percentage do you think will get prostate cancer before the age of 75?" If the respondent was unable to quantify his response, the interviewer was instructed to establish a range by saying "Would it be more or less than 1%? Less than 5%? Between 5% and 9%? More than 10% or more than 20%?" until an answer was given. 5. "Out of 100 Australian men, how many or what percentage do you think will die from prostate cancer before the age of 75?" If necessary, an answer to this question was prompted in the same way as Question 4. For Questions 4 and 5, interviewers were unaware of the correct answers. Questions 4 and 5 were modelled on previous research. 12 Data analysis Data were analysed using SAS13 and Epi Info.14 We used chi-squared tests to examine associations between knowledge of prostate cancer screening tests and eight respondent characteristics: age (40-49, 50-59, 60-69, 70-80 years); country of birth (Australia v. other); socioeconomic status based on occupation (manager/ administrator and professional/para-professional combined v. all other categories [tradesperson/clerk/salesperson and personal service worker/plant and machine operator/driver and labourer]);15 education (up to and including Intermediate or School Certificate [Year 10] v. Leaving or Higher School Certificate [Year 11 or 12] and beyond); moderate or severe "bother" from urinary symptoms (a score equal to or greater than six from a possible range of 0-18); ever worrying about prostate cancer (yes v. no); estimate of risk of developing prostate cancer (correct or lower estimate v. overestimate); and estimate of risk of death from prostate cancer (correct or lower estimate v. overestimate). Jelfs et al. report a lifetime risk of developing prostate cancer of one in 18 (6%).16 We considered an estimate of 10% or greater to be an overestimate of incidence risk. Using the Jelfs data,16 we calculated the lifetime risk of dying of prostate cancer as one in 65 (1.5%). We considered an estimate of 5% or greater as an overestimate of mortality risk. For the sample of men 50 years and over, we used chi-squared tests to determine associations between the outcome variable -- having had either a prostate specific antigen test, a digital rectal examination, or both, within the previous 12 months -- and these eight variables as well as knowledge of prostate cancer tests. Logistic regression analysis was performed, using significant univariate variables and any plausible non-significant variable. Results Response rate and characteristics of the sample Of 2000 randomly selected households, 1481 (74%) were ineligible. Of the remaining 519 households with an eligible male resident, 340 agreed (65% response rate). Men who refused were significantly older than those who participated (t27.49 = 4.19; P < 0.01). Compared with 1991 Census data12 (Box 1), the sample under-represented older men. No respondent indicated a past history of prostate cancer. Respondents' worry about prostate cancer, estimates of risk and knowledge of tests Ninety-nine men (29%) indicated they had ever worried about prostate cancer. The three most frequently cited reasons were: presence of urinary symptoms (36 men [11%]), age (26 men [8%]), and media publicity (24 men [7%]). Of the sample, 216 men (63%) overestimated lifetime risk of developing prostate cancer (Box 2). Respondents were significantly more likely to overestimate the risk of death from prostate cancer than the risk of developing it (McNemar's test, 10.800; df = 1; P = 0.001). Ever having worried about prostate cancer was not associated with correctly estimating the risk of developing it or the risk of dying from it. Of the total sample, 237 (70%) and 228 (67%) required no prompting to estimate lifetime risk of developing or dying from prostate cancer, respectively. One hundred and seventy-two men (51%) reported they had heard of one or more tests for prostate cancer. Respondents who had heard of any test were more likely to be managers or professionals than to have other occupations (chi-squared = 4.04; df = 1; P = 0.044) or were educated to Year 12 or beyond (chi-squared = 5.49; df = 1; P = 0.019). Knowledge of tests was unrelated to age, country of birth, perception of risk, "bother" from urinary symptoms or anxiety. Rates and predictors of prostate cancer screening within the previous 12 months Of the total sample, 52 men (15%) had had at least one prostate cancer screening test within the previous 12 months (Box 3). Almost all tests (97%) were reported by men 50 years or older, yielding an annual screening rate of 22% for this older group. For the subsample of 186 men aged 50 years or over, univariate analyses revealed only two variables to be significantly associated with having had a prostate cancer screening test within the past year: moderate or severe "bother" from urinary symptoms (chi-squared = 13.41; df = 1; P < 0.001), and "ever worrying" about prostate cancer (chi-squared = 18.38; df = 1; P < 0.001). Knowledge of available tests and other sociodemographic variables were not associated with having had a test within the past year. However, as age was a potential confounder, it was included with the two significant univariate associations in the logistic regression analysis. After adjustment, "bother" and "anxiety" remained independent predictors (Box 4). Discussion Just over one in five of the men in our study 50 years or over had had a prostate cancer screening test within the previous 12 months, a rate almost double that given in an earlier report of national claims data.5 Screening was significantly more likely among those who had ever worried about prostate cancer or were bothered by urinary symptoms. In contrast to research in other countries demonstrating that economic and ethnic factors influence participation in prostate cancer screening,17,18 our study showed no association between screening and men's occupation, education or country of birth. As a priority for public campaigns, men who experience uncomplicated LUTS -- nocturia, frequency, dribbling, urgency, hesitancy or reduced stream -- in the absence of haematuria need to be reassured that there is no empirical evidence of a relationship between such symptoms and early prostate cancer.3 Men's anxiety about prostate cancer may also be explained, in part, by their overestimation of the actual risks of prostate cancer. More than a third of respondents thought that at least one in five men would develop prostate cancer before the age of 74 years, and 11% thought that one in five would actually die from this disease before that age. Reasons for consistent overestimation of risk remain speculative but might reflect extensive media coverage of prostate cancer, possibly fuelled by commercial interests, which increases men's anxiety, and, in turn, raises their perception of risk.19 In contrast, McCormick20 has argued that informed public participation in screening should be founded on clear messages about absolute risk, the evidence from rigorous randomised trials for reduction in risk, the costs and adverse outcomes. Our study is the first to quantify a considerable gap between men's perceptions of risk and the actual risk. When provided with impartial information on an individual basis about the risks and unknown benefits of prostate cancer screening, men are less inclined to have a screening test.21 Given our collective failure to convey accurate health risk information to the public about risks for other cancers,9 risk reduction22 or screening,23 a systematic approach to the development, implementation and evaluation of a public health initiative to discourage prostate cancer screening is required. The recent release of the guidelines for the management of uncomplicated LUTS in men3 provides a focus for such an initiative. Our study suggests that men who are anxious about prostate cancer or have bothersome urinary symptoms represent priority target groups for educational messages via general practice, men's service and recreation clubs, mass media and peak groups such as the Council of the Ageing and the Consumers' Health Forum. Because of the limitations of our study, we also recommend that a dedicated survey about prostate cancer be conducted which examines in depth men's knowledge of indolent and aggressive cancer types, their health beliefs and attitudes towards early detection, their awareness of the speculative and controversial nature of screening, and their knowledge of treatment options and their effectiveness. Men's recall of the recommendations of their GP in either promoting or discouraging prostate cancer screening could also be ascertained. As female partners represent a key source of health information for men,24 a concurrent survey of partners of men in these age groups is also recommended. Acknowledgements The Men's Health Study was conducted for the NHMRC Working Party developing guidelines for the management of lower urinary tract symptoms in men with funds from the Commonwealth Department of Health and Family Services. We thank members of the Working Party for comments on survey protocols; the men who participated in the computer-assisted telephone interview and the Hunter Valley Research Foundation for diligent administration of the survey; Jo Williams and the Central Sydney Area Health Service Public Relations Unit for assisting with the media release; and Neil Donnelly for statistical advice. References Australian Cancer Society. Prostate cancer screening: guidelines for health professionals. Cancer Forum 1995; 19: 47-50. Australian Health Technology Advisory Committee. Prostate cancer screening. Canberra: AGPS, 1996. NHMRC clinical practice guidelines. The management of uncomplicated lower urinary tract symptoms in men. Canberra: AGPS, 1996. Catalona W, Ritchie J, Ahmann F, et al. Comparison of digital rectal examination and serum prostate specific antigen in the early detection of prostate cancer: results of a multicenter clinical trial of 6,630 men. J Urol 1994; 151: 1283-1290. Parkes A, Killer G. Prostate-specific antigen -- is it already being used as a screening test? Med J Aust 1994; 161: 722. Urological Society of Australasia. Prostate screening, a personal choice: surgeons. Media release, 27 August 1996. Horner D. Prostate cancer: a challenge for health promotion. Health Promot J Aust 1996; 6: 3-7. Cancer Expert Working Group. Cancer control NSW goals and targets. North Sydney: NSW Health, August 1995. Oz On Disc. Sydney: Read Only Memory Pty Ltd, May 1996. Rissel C, Winchester L, Hodge W, et al. Health outcome indicators for Central Sydney. Sydney: Needs Assessment & Health Outcomes Unit, Central Sydney Area Health Service, August 1996. Cockett A, Aso Y, Denis L, et al. Recommendations of the International Consensus Committee. In: Proceedings of the International Consultation on Benign Prostatic Hyperplasia (BPH). Paris: SCI, June 1991: 279-281 (ISBN 2-905744-11-1). Clover K, Redman S, Boyle K, et al. Community knowledge of cancer. Health Promot Int 1991; 6: 93-101. SAS [computer program], version 6. 3rd ed. Cary, NC: SAS Institute, 1990. Dean AG, Dean JA, Burton AH, Dicker RC. Epi Info, version 5: a word processing database, and statistics program for epidemiology on microcomputers. Stone Mountain, Ga: USD Inc, 1990. Australian Bureau of Statistics. Australian standard classification of occupations. 1st ed. Canberra: AGPS, 1992. Jelfs P, Coates M, Giles G, et al. Cancer in Australia 1989-1990 (with projections to 1995). Canberra: Australian Institute of Health and Welfare, 1996 (Cancer Series No. 5). Schwartz K, Kau T, Severson R, Demers R. Prostate-specific antigen in a community screening program. J Fam Pract 1995; 41: 163-168. Williams R, Boles M, Johnson R. Use of prostate-specific antigen for prostate cancer screening in primary care practices. Arch Fam Med 1995; 4: 311-315. Wasson J. Prostate cancer fears and facts. In: Proceedings of the National Men's Health Conference; 10-11 August 1995. Canberra: AGPS, 1996: 69-72. McCormick J. Medical hubris and the public health: the ethical dimension. J Clin Epidemiol 1996; 49: 619-621. Wolf A, Nasser J, Wolf A, Schorling J. The impact of informed consent on patient interest in prostate-specific antigen screening. Arch Intern Med 1996; 156: 1333-1336. Hancock L, Sanson-Fisher RW, Redman S, et al. Knowledge of cancer risk reduction practices in rural towns of NSW. Aust N Z J Public Health 1996; 20: 529-537. Cockburn J, Redman S, Hill D, Henry E. Public understanding of medical screening. J Med Screen 1995; 2: 224-227. Norcross W, Ramirez C, Palinkas L. The influence of women on the health care-seeking behaviour of men. J Fam Pract 1996; 43: 475-480. (Received 24 Feb, accepted 22 May 1997) Subsequently cited in Prostate-specific antigen testing in Australia and association with prostate cancer incidence in New South Wales by David P Smith and Bruce K Armstrong, Med J Aust 1998; 169: 17-20 Authors' details Central Sydney Area Health Service, Needs Assessment & Health Outcomes Unit, Sydney, NSW. Jeanette E Ward, PhD, FAFPHM, Director; Ann-Maree Hughes, BEd, GradDipAppSci(Nursing), Research Assistant; Lorraine Winchester, BSocSc(Hons), Data Manager. Taylor Medical Centre, Brisbane, QLD. Geoffrey H L Hirst, MB BS, FRACS, Urologist. Reprints: Associate Professor J E Ward, Central Sydney Area Health Service, Needs Assessment & Health Outcomes Unit, PO Box 374, Camperdown, NSW 2050. E-mail: jward AT nah.rpa.cs.nsw.gov.au ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Jeanette E Ward · Anne-Maree Hughes · Lorraine Winchester

A high incidence of melanoma found in patients with multiple dysplastic naevi by photographic surveillance John W Kelly, Josephine M Yeatman, Cheryl Regalia, Grahame Mason and Amanda P Henham Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". Abstract - Introduction - Methods - Results - Discussion - References - Authors' details - - ©MJA1997 Abstract Objectives: (1) To assess the incidence of melanoma in a cohort of patients with dysplastic melanocytic naevi (DMN) and the relationships between incident melanomas and preexisting naevi and between melanoma risk and numbers of DMN. (2) To examine the role of the patient versus the physician in detecting melanoma and the relative value of surveillance versus prophylactic excision. Design: Prospective cohort study. Patients and setting: Two hundred and seventy-eight adults, each with five or more DMN, were followed up for a mean period of 42 months in a private dermatology practice. DMN were clinically diagnosed. Results: Twenty new melanomas were detected in 16 patients, corresponding to an age-adjusted incidence of 1835/100 000 person-years, 46 times the incidence in the general population. Eleven were detected because of changes evident in comparison with baseline photographs and nine were detected by patients or their partners. Thirteen of the 20 melanomas arose as new lesions and only three from DMN. Melanoma risk rose with increasing numbers of DMN. Conclusions: Increasing numbers of DMN are associated with increasing melanoma risk. Surveillance (baseline photography and follow-up) enabled early diagnosis of melanoma and was very much more cost-effective in preventing life-threatening melanoma than prophylactic excision of DMN. MJA 1997; 167: 191-194 Introduction Eight case-control studies have indicated that dysplastic melanocytic naevi (DMN) are a strong and independent risk factor for the development of melanoma.1-8 Cohort studies show that individuals with DMN develop more melanomas than the general population.9-14 Only one cohort study has assessed the association of incident melanomas with preexisting naevi and the role of the patient versus the clinician in detection.10 None has examined an Australian cohort or addressed the relationship between DMN numbers and melanoma risk, the cost-effectiveness of surveillance compared with prophylactic excision or the occurrence of non-melanoma skin cancer in subjects with DMN. We followed a cohort of 278 Australian patients with DMN, using baseline skin surface photography to address these issues. Methods All patients who presented to the private dermatological practice of one of us (J W K) between March 1985 and November 1992 who required total body cutaneous examination were assessed for entry to the study. Any who had five or more clinically determined DMN and who were aged 18 years or more were offered baseline skin surface photography and follow-up on an annual basis. Over 80% had been referred for assessment of their atypical naevi or because of other melanoma risk factors, particularly a personal or family history of melanoma. In November 1993 all patients who had baseline photographs and had returned for at least one 12-month follow-up visit were entered in the study. The entry criterion of five DMN was based on the results of an earlier study that suggested to us that this number of DMN is associated with sufficient melanoma risk to justify entry to a screening program.2 A systematic set of 14 baseline photographs of the skin surface was used. A clinical photographer (A P H) worked with us in designing the views and did the photography, using anatomical site definitions to define standard views of recognisable body regions rather than using standard magnifications (Box 1). This reduced the number of views needed to cover the skin surface while providing adequate magnification. At entry to the study subjects were advised about their high risk of mela noma; three-monthly self-examination was recommended, the clinical features of early melanoma were discussed and appropriate sun protection measures were described. DMN were diagnosed clinically accor ding to published criteria.15 A naevus was considered clinically dysplastic if it had a macular component and showed at least three of the following five clinical features: ill-defined border, irregularly distributed pigmentation, background erythema, size greater than 5 mm, and irregular border. An exact count was made of the number of DMN and recorded in ranges 1-4, 5-10, 11-20, 21-50 and >50. The total number of MN was estimated and recorded in ranges <20, 21-50, 51-100 and 101-500. Patients were reviewed at 6- to 12- month intervals. Total body cutaneous examination was performed at each visit and the patient's pigmented lesions were compared with baseline photographs. Excisional biopsies were performed for any lesions that were clinically suggestive of melanoma and were not done routinely for histological confirmation of the presence of dysplastic naevi. All histo pathological specimens were examined at a single private pathology laboratory. All melanomas arising during the study were reviewed by one pathologist (G M). Melanomas detected at the initial visit were excluded from the analysis. Results The study enrolled 278 patients (162 women and 116 men). Mean age was 37 years (range, 18-67 years). Sixty-five patients (23%) had a family history of melanoma, 54 (19%) had a past history of melanoma, and 9 (3%) had both. None were from melanoma-prone families (as defined by a history of two or more affected first degree relatives). The mean period of follow-up was 42 months (range, 12-99 months). Twenty melanomas were detected in 16 patients over 955 person-years of follow-up. The age-adjusted incidence of melanoma in this group was 1835/100 000 person-years, 46 times the age-adjusted incidence of in-situ and invasive melanoma of 40/100 000 person-years for the population of Victoria in 1990 (G Giles, Anti-Cancer Council of Victoria, 1996, personal communication). The mean time from baseline to diagnosis of melanoma was 36 months (SD, 12 months; range, 11-75 months). Eleven of the 20 melanomas were detected at follow-up visits by comparison with the baseline photographs. These 11 patients were unaware of the changing lesion, and in most of these lesions the change would not have been apparent to the clinician without the use of photo graphs. Seven melanomas were detected by the patient as a change seen on self-examination and two were detected by patients' partners. Four were amelanotic melanomas that did not fulfil the normal diagnostic criteria for melanoma; nonetheless, one of these was detected by the patient. Detecting the 20 melanomas in these 278 patients required 1554 patient consultations (78 for each melanoma). Two hundred and ten biopsies were performed to assess changes observed during follow-up of 104 patients (10 biopsies for each melanoma detected). Not all changes in pigmented lesions led to a biopsy: if melanoma could be confidently ruled out on clinical examination and skin surface microscopy, the lesion was simply rephoto graphed. Histopathological results of these biopsies are shown in Box 3. Changing dysplastic naevi were the predominant source of clinically suspicious change; we do not know how many of these may have progressed to melanoma if they had not been removed. Nineteen non-melanoma skin cancers were detected during follow-up in this group of patients and removed: 16 basal cell carcinomas, one squamous cell carcinoma, one keratoacanthoma, and one Bowen's disease. Of the 16 patients who developed mela noma, five had a family history and seven had a past history of melanoma. Patients with melanoma were more likely to have had a previous melanoma (P = 0.001) and to have a family history of melanoma (P = 0.05) than those who had not. The percentage of patients in each risk group who developed melanoma is shown in Box 2. Boxes 4 and 5 show the incidence of melanoma in the study cohort in relation to the number of dysplastic naevi and total naevi. For an Australian population, the total numbers of naevi were not remarkable (61% had 100 naevi or less), but there were large numbers of DMN (59% had more than 10). Melanoma incidence correlated more closely with increasing numbers of DMN than with increasing total numbers of naevi. Subjects with 21 to 50 DMN developed melanomas at a rate of 3.3% per year. The 20 incident melanomas were all superficial spreading in type. Twelve were invasive and eight were in situ. All the invasive lesions were less than 0.6 mm thick and level II,16 except one amelanotic melanoma that showed a desmoplastic component and invaded to 1 mm in thickness and reached level IV.16 According to the criteria of Clark et al.,17 15 were classified as radial growth phase lesions and four as vertical growth phase; one was classified separately as desmoplastic. The melanomas were widely scattered over the skin surface, with six on the upper limbs, four on the upper back, four on the lower limbs, three on the chest, two on the abdomen, and one on the head. Seven melanomas showed histological evidence of an associated benign naevus (intradermal naevoid remnants in four and features of dysplastic naevi in three). Nine melanomas evolved as a change in a preexisting pigmented lesion that had been evident on baseline photos. In two of these nine the preexisting pigmented lesion was likely to have been a de novo melanoma. One of these patients had a stable pigmented lesion on the right side of her chest over six years. It was excised when it began to enlarge and darken and was found to be a level II, 0.6 mm thick melanoma without histological evidence of any associated naevus. A second patient had a tiny, 2 mm diameter lesion on his chest at his first visit. At his initial review visit, six months later, this had enlarged slightly and become more angular in shape. Histologically, this was a level I melanoma with no associated naevus. Discussion In this study the presence of five or more clinically determined DMN identified a group of patients with 46 times the general population incidence of melanoma. None of these patients came from melanoma-prone families, in whom Clark et al. originally described dysplastic naevi.18 Five cohort studies of patients with DMN who are not from melanoma-prone families have been published and all showed a very high rate of mela noma.9-13 These findings confirm those from case-control studies showing that DMN constitute a strong and independent risk factor for melanoma.1-8 Our age-adjusted incidence of mela noma of 1835/100 000 person-years is higher than that reported in other studies (692-709/100 000 person-years).9,11 This may be explained by the relatively large numbers of DMN in our patients (Box 4) and by the higher background rate of melanoma in Austra lia than in the United States and United Kingdom. We did not examine a cohort of control patients, but Marghoob et al. did.12 They found a 10-year cumulative risk of melanoma of 10.7% among 287 patients with at least one large naevus, one atypical naevus and 100 total naevi. This risk compared with a 0.62% 10-year risk among 831 controls selected from patients requiring annual dermatological follow-up for other reasons. We have intentionally continued to use the word "dysplastic" rather than "atypical". These naevi have been studied because they are believed to be associated with melanoma risk. There are other naevi that are clinically atypical and that are not linked with melanoma risk. Examples are naevus spilus, blue naevus and halo naevus. We prefer the term "dysplastic" because it clearly does not embrace these other atypical naevi. There are several definitions in the literature for syndromes associated with atypical or dysplastic naevi. One includes patients with a single atypical naevus, a large (>8 mm diameter) naevus and >100 total naevi.12 Another depends on distribution of atypical naevi on the anterior scalp, dorsa of the feet, iris or buttocks.19 DMN have been demonstrated to be independently associated with mela noma risk and are not always associated with large numbers of naevi or naevi in certain locations. We prefer not to include DMN in a syndrome definition but rather to consider them as a continuous numerical variable. There is evidence from this study (Box 2) and from two case-control studies of increasing risk with increasing numbers of DMN.2,11 The risk associated with a single DMN is likely to be small and insufficient to justify our follow-up regimen. It is also difficult to accurately diagnose a single naevus as being dysplastic or otherwise on clinical grounds, but much more easy to identify the patient with numerous DMN. It is also difficult to apply definitions of large numbers of naevi in different geographical locations. A recent Australian study reported a mean total count of naevi (>2 mm diameter) that approached 100 in 15-year-old adolescents, which is considered a large number in the United States and United Kingdom.20 The proportion of the Australian adult population with five or more dysplastic naevi has not been defined. One study of 1123 Australian schoolchildren aged 6-15 years showed that 2.7% had three or more dysplastic naevi according to the clinical definition applied here.21 Two-thirds of the incident melanomas in this study were de novo lesions. This finding is similar to those of studies that examine the histological frequency of associated naevi with melanoma, which suggest that 43%-77% of melanomas are new lesions.22-24 The predominance of de novo melanoma in these patients supports management by photographic surveillance rather than by attempts at prophylactic excision. If every one of the 5838 DMN present in our cohort of patients had been excised at the outset, only three of the incident melanomas would have been prevented. Ninety-three DMN were excised in the course of the study because of changes evident in comparison with photographs and because the possibility of melanoma could not be confidently excluded. These changing DMN would seem to be the most likely pigmented lesions to develop into melanoma, and it is possible that some would have progressed to melanoma had they been left in place. When consultations and biopsies are costed at the Australian Government's Medi care Schedule rates for 1997 and $100.00 is allowed per set of photo graphs, the cost of diagnosing each mela noma in this study is $5583. Prophy lactic excision of all dysplastic naevi would have cost $1118038 and would have prevented only three of 20 mela nomas, at a cost of $395038 each. The use of baseline photographs in patients with many floridly atypical pigmented lesions provided knowledge of the stability of many lesions that would otherwise have demanded excisional biopsy, and greatly reduced the number of excisions needed in managing such patients. Patients commonly presented with concern about a change in a particular pigmented lesion. Reference to the photographs usually revealed no change and the lesion remained under observation. Only 10 biopsies were necessary to detect each melanoma and less than one biopsy was necessary per subject in the course of this study. The melanomas incident in this study were detected at an earlier stage than other melanomas that were incident in the State of Victoria in 1990. In-situ melanomas comprised 45% of those seen in the DMN cohort and 33% of those seen in Victoria for 1990 (G Giles, Anti-Cancer Council of Victoria, 1996, personal communication). Median tumour thickness was 0.40 mm in our cohort and 0.77 mm for the State in 1990. Mean tumour thickness for invasive melanoma in the cohort was 0.44 mm compared with 1.40 mm (95% confidence interval, 1.29-1.51) for the State. It is possible that such close surveillance leads to the detection of some melanomas that would otherwise have remained undetected and may have regressed spontaneously or failed to progress and become life threatening. Such "harvesting" of early melanomas may contribute to the very high incidence observed. We conclude that numerous dysplastic naevi identify patients at high risk of melanoma. Baseline photography of the entire skin surface and 6-12-monthly surveillance provides an effective method for early detection of incident melanomas. As most new melanomas were de novo lesions, prophylactic excision of dysplastic naevi would not have provided a satisfactory alternative to follow-up and does not provide sufficient risk reduction to justify the cost and morbidity of the procedure. References Grulich AE, Bataille V, Swerdlow AJH, et al. Naevi and pigmentary characteristics as risk factors for melanoma in a high-risk population: a case-control study in New South Wales, Australia. Int J Cancer 1996; 67: 485-491. Holly EA, Kelly JW, Shpall SN, et al. Number of melanocytic nevi as a major risk factor for malignant melanoma. J Am Acad Dermatol 1987; 17: 459-468. Swerdlow AJ, English J, MacKie RM, et al. Benign melanocytic naevi as a risk factor for malignant melanoma. BMJ 1986; 292: 1555-1559. Augustsson A, Stierner U, Rosdahl I, et al. Common and dysplastic naevi as risk factors for cutaneous malignant melanoma in a Swedish population. Acta Derm Venereol (Stockh) 1990; 71: 518-524. Halpern AC, Guerry D, Elder DE, et al. Dysplastic nevi as risk markers of sporadic (nonfamilial) melanoma. Arch Dermatol 1991; 127: 995-999. Grob JJ, Gouvernet J, Aymar D, et al. Count of benign melanocytic naevi as a major indicator of risk for nonfamilial nodular and superficial spreading melanoma. Cancer 1990; 66: 387-395. Garbe C, Kruger S, Stadler R, et al. Markers and relative risk in a German population for developing malignant melanoma. Int J Dermatol 1989; 28: 517-523. Roush GC, Nordlund JJ, Forget B, et al. Independence of dysplastic nevi from total nevi in determining risk for nonfamilial melanoma. Preventive Medicine 1988; 17: 273-279. Mackie RM, McHenry P, Hole D. Accelerated detection with prospective surveillance for cutaneous malignant melanoma in high risk groups. Lancet 1993; 3421: 1618-1620. Rivers JK, Kopf A, Vinokur AF, et al. Clinical characteristics of malignant melanomas developing in persons with dysplastic naevi. Cancer 1990; 65: 1232-1236. Halpern AC, Guerry D, Elder DE, et al. A cohort study of melanoma in patients with dysplastic nevi. J Invest Dermatol 1993; 100: 346-349. Marghoob AA, Kopf AW, Bart RS, et al. Risk of cutaneous malignant melanoma in patients with "classic" atypical mole syndrome. Arch Dermatol 1994; 130: 993-998. Kang S, Barnhill RL, Mihm MC, et al. Melanoma risk in individuals with clinically atypical naevi. Arch Dermatol 1994; 130: 999-1001. Schneider JS, Moore DH, Sagebiel RW. Risk factors for melanoma incidence in prospective follow-up. The importance of atypical (dysplastic) nevi. Arch Dermatol 1994; 130: 1002-1007. Kelly JW, Crutcher WA, Sagebiel RW. Clinical diagnosis of dysplastic melanocytic nevi. J Am Acad Dermatol 1986; 14: 1044-1052. Clark WH Jr, From L, Bernadino EH, et al. Histogenesis and biological behaviour of primary human malignant melanoma of the skin. Cancer Res 1969; 29: 705-727. Clark WH, Elder DE, Guerry D, et al. Model predicting survival in stage I melanoma based on tumour progression. J Natl Cancer Inst 1989; 81: 1893-1904. Clark WH, Reimer RR, Greene M. Origin of familial malignant melanomas from heritable melanocytic lesions. Arch Dermatol 1978; 114: 732-738. Newton JA, Bataille V, Griffiths K, et al. How common is the atypical mole syndrome phenotype in apparently sporadic melanoma? J Am Acad Dermatol 1993; 29: 989-996. Kelly JW, Rivers JK, MacLennan R. Sunlight: a major factor associated with the development of melanocytic nevi in Australian school children. J Am Acad Dermatol 1994; 30: 40-48. Rivers JK, Maclennan R, Kelly JW, et al. The Eastern Australian childhood nevus study: prevalence of atypical nevi, congenital nevus-like nevi, and other pigmented lesions. J Am Acad Dermatol 1995; 32: 957-963. Marks R, Dorevitch AP, Mason G. Do all melanomas come from "moles"? A study of the histological association between melanocytic naevi and melanoma. Australas J Dermatol 1990; 31: 77-80. Sagebiel RW. Melanocytic nevi in histologic association with primary cutaneous melanoma of superficial spreading and nodular types: Effect of tumour thickness. J Invest Dermatol 1993; 100 Suppl: 322S-325S. Skender-Kalnenas TM, English DR, Heenan PJ. Benign melanocytic lesions: risk markers or precursors of cutaneous melanoma? J Am Acad Dermatol 1995; 33: 1000-1007. (Received 10 Dec 1996, accepted 10 Jun 1997) Authors' details Victorian Melanoma Service, Alfred Hospital, Melbourne, VIC. John W Kelly, MD BS, FACD, Head; Head of Dermatology Unit, Alfred Hospital; Clinical Associate Professor, Monash University Department of Medicine. Dermatology Unit, Alfred Hospital, Melbourne, VIC. Josephine M Yeatman, MB BS, GradDipEpi, Registrar. Cheryl Regalia, Medical student, University of California at San Diego; now MD. Dorevitch Laboratories, Melbourne Grahame Mason, MB BS, FRCPA, Pathologist. Department of Photography, Northern Territory University, Darwin, NT. Amanda P Henham, BAppSci(Photog), SRN, Lecturer. Reprints: Dr J W Kelly, Victorian Melanoma Service, Alfred Hospital, Commercial Road, Prahran, VIC 3181. ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

John W Kelly · Josephine M Yeatman · Cheryl Regalia · Grahame Mason · Amanda P Henham

Systematic review of the diagnostic accuracy of dermatoscopy in detecting malignant melanoma Justine Mayer Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". Abstract - Introduction - Methods - Data sources - Study selection and data extraction - Results - Design and validity of selected studies - Results of selected studies - Discussion - Acknowledgements - References - Authors' details - - ©MJA1997 Abstract Objective: To assess the evidence that dermatoscopy improves the accuracy of diagnosis of melanomas in clinical practice. Data sources: MEDLINE 1983-January 1997, EMBASE 1980-1996, and bibliographies of retrieved articles. Study selection and data extraction: Studies selected were original studies with formal methods and results sections comparing diagnostic accuracy of dermatoscopy for malignant melanoma with another clinical method; the criterion standard was excision biopsy with histopathological examination; and accuracy of dermatoscopic diagnosis was determined over a spectrum of stages of melanoma and skin lesions commonly confused with melanoma. Data were extracted by a single observer. Data synthesis: 579 articles were identified; six studies met the inclusion criteria. Positive likelihood ratios for dermatoscopy for diagnosis of melanoma ranged from 2.9 to 10.3. Dermatoscopy had 10%-27% higher sensitivity than clinical diagnosis in the two studies with the most clinically equivocal lesions. However, when sensitivity of clinical diagnosis was more than 84%, sensitivity of dermatoscopy was only slightly higher. One study of dermatologists with no training in dermatoscopy showed a significant decrease in sensitivity. Conclusions: Variability between studies in methods, observers and types of pigmented skin lesions and lack of studies in primary care make generalisation of results difficult. Dermatoscopy appeared not to improve the accuracy of diagnosis enough to alter the clinical management of most pigmented skin lesions. Further research with more explicit methods is needed. MJA 1997; 167: 206-210 Introduction Malignant melanoma is an important cause of morbidity and mortality in Australia. Public health strategies emphasise, in addition to reducing sun exposure, early diagnosis and treatment. It has been claimed that dermatoscopy improves the accuracy of diagnosis of malignant melanomas,1,2 but calls have also been made for a systematic review of the evidence3 (see Box 1 for description of dermatoscopy). An ideal diagnostic test achieves maximum levels of sensitivity and specificity. However, as sensitivity reflects a test's ability to identify individuals with the disease, most clinicians considering the diagnosis of melanoma would prefer a test with high sensitivity. Furthermore, diagnostic tests should be performed only if they have the potential to alter clinical management. For pigmented skin lesions, this means helping decide whether to excise the lesion. This review aimed to identify primary studies that researched the diagnostic accuracy of dermatoscopy compared with clinical diagnosis and to assess their implications for clinical practice. Methods The review followed current recommendations on systematic reviews of the accuracy of diagnostic tests.7,8 Data sources MEDLINE Express (Silverplatter Winspirs) on CD-ROM databases January 1983-January 1997 and Elsevier Science EMBASE Database 1980-1996 were searched. The Medline search was conducted with exploded MeSH headings "melanoma" or "skin neoplasms", combined with "sensitivity and specificity", and with text words "dermoscop*", "dermatoscop*", "skin surface microscop*", "epiluminesc*", or "incident light microscop*". Similar strategies were used to search EMBASE. Study selection and data extraction Abstracts of articles were reviewed by the author for studies that met the selection criteria: Original study with a formal methods and results section comparing the diagnostic accuracy of dermatoscopy for malignant melanoma with another method of clinical diagnosis; Excision biopsy with histopathological examination was the criterion standard; and The accuracy of dermatoscopic diagnosis was determined over a large range of pigmented skin lesions, including a spectrum of stages of melanoma and lesions commonly confused with melanoma. Articles describing studies that appeared to meet the criteria were retrieved for more detailed review (after translation if not in English). Bibliographies of articles retrieved were also checked for articles not listed or incorrectly indexed in MEDLINE or EMBASE. Articles that did not meet the selection criteria included those on the terminology of dermatoscopic techniques, development of criteria for diagnosing pigmented skin lesions, observer error of diagnosis, accuracy of diagnosis of a single type of pigmented skin lesion, and accuracy of digital imaging computer programs. Studies providing data on the sensitivity and specificity of dermatoscopy but with no comparison group were also excluded.9,10 Articles that met the selection criteria were reviewed for study validity and applicability to clinical practice.11 The methods section of each article was checked for explicit mention of the criterion standard of histopathological examination, blinding of observers, spectrum of pigmented skin lesions, study setting, patient demographics, prevalence of melanoma, sample size, intraobserver and interobserver error, and the proportion of pigmented skin lesions in which no dermatoscopic diagnosis could be made. Results Three hundred and thirty-six articles were identified from MEDLINE and 243 from EMBASE. Six articles met the inclusion criteria.4,12-16 All were indexed in MEDLINE and one in EMBASE and all were in English. No further articles meeting the inclusion criteria were found on review of the bibliographies of retrieved articles. Design and validity of selected studies The designs of the six studies are summarised in Box 2. Assessment of the studies' internal and external validity was hampered by lack of information. Only Binder et al.14 provided sufficient details of methods to enable the study to be repeated. All studies were set in specialist dermatology clinics, but none provided further details of the setting (i.e., whether a secondary or tertiary referral centre). They investigated selected groups of pigmented skin lesions, with melanomas comprising 15%-41%, but only one study explicitly stated how lesions were chosen for entry into the study.12 All appeared to include only lesions to be excised because of presumed risk of malignancy or, possibly, patient request. None commented on the suitability of the sample to detect clinically important differences in the diagnostic methods being evaluated, and none provided data on all presenting lesions or followed them up to calculate the true false negative rate. Although all studies used the criterion standard of histopathological examination, none commented on how the histological diagnosis was reached, although pathologists may vary in classifying pigmented skin lesions.24,.25 Only four studies provided objective data on melanoma diameter or Breslow depth.4,12,14,15 Five studies assessed dermatoscopy results in vivo and one, from photographic slides.14 Observers in the in vivo studies were assumed to be blinded to the histopathological results, but it was not apparent that clinical and dermatoscopic diagnoses were independent, despite the importance of history in the diagnosis of malignant lesions. Five studies did not provide the criteria used for clinical diagnosis, and only Binder et al. provided complete details of the method of non-dermatoscopic examination. The diagnostic criteria and method of surface microscopy used differed between the studies. Three studies used handheld monocular dermatoscopes with x 10 magnification,4,13,16 and two studies used binocular stereomicroscopes with magnification up to x 40.12,14 One study used both types of instrument, but did not clearly distinguish their results.15 No study remarked that a skin lesion was unable to be diagnosed by dermatoscopy. Results of selected studies Results of the six studies are shown in Box 2. Five of the studies compared dermatoscopy with clinical diagnosis or diagnosis by microscopy without oil. Likelihood ratios for a positive diagnosis of melanoma by dermatoscopy ranged from 2.9 to 10.3 (meaning that pigmented lesions diagnosed as melanoma by dermatoscopy were 2.9 to 10.3 times morelikely to be melanoma than not). Two studies found that dermatoscopy had higher sensitivity than non-dermatoscopic diagnosis,12,13 one found no difference,15 and one found that dermatoscopy increased sensitivity when performed by experts, but decreased it when performed by dermatologists without training in the technique.14 Pazzini et al. provided insufficient data to calculate sensitivity.16 Nachbar et al.4 compared two forms of dermatoscopy -- with explicit structured diagnostic criteria and without these criteria, but combined with clinical diagnosis. They found that dermatoscopy with structured ABCD criteria19,21 (specific for dermatoscopy and differing from the ABCDE criteria for clinical diagnosis) had higher sensitivity and specificity than dermatoscopy without such criteria. Clinical diagnosis varied widely in sensitivity and specificity between the studies, most likely because the lesions varied in their ease of diagnosis. Observers may also have varied in their ability to make the diagnosis. This variability prevented formal meta-analysis and estimation of a single summary statistic for the diagnostic benefit of dermatoscopy. The studies that provided results for handheld monocular dermatoscopes with x 10 magnification are most relevant to clinical practice.4,13 Cristofolini et al.13 found that dermatoscopy with pattern-analysis criteria had slightly higher sensitivity (88%) and specificity (79%) than clinical diagnosis with ABCDE criteria.18 However, the latter was already highly accurate (sensitivity, 85%; specificity, 75%). Nachbar et al. found that dermatoscopy with structured criteria had higher sensitivity (93% versus 84%) and specificity (91% versus 84%) than without such criteria.4 Interestingly, the studies that showed the greatest improvement in sensitivity for dermatoscopy were those that had the lowest baseline sensitivity for clinical diagnosis. Steiner et al.12 found that dermatoscopy increased sensitivity from 59% to 86% (an increase of 27%) compared to microscopy without oil. Binder et al.14 found dermatoscopy performed by experts increased sensitivity from 58% to 68% (increase of 10%) compared to clinical diagnosis. Both these studies appeared to include small difficult-to-diagnose lesions, suggesting that dermatoscopy may be most useful in these circumstances. In contrast, when clinical diagnosis was very accurate (as found by Soyer et al.15) dermatoscopy was of no benefit. This study also provided data on the accuracy of individual dermatoscopy criteria (not shown). The study by Binder et al. also examined two further important issues. They found that, although dermatoscopy had higher sensitivity than clinical diagnosis when performed by experts, it had lower sensitivity when performed by dermatologists with no formal training in the technique; these observers misdiagnosed more melanomas with dermatoscopy. Further, while experts showed moderate interobserver and intraobserver agreement (average k = 0.47 and 0.56, respectively), non-experts showed only fair agreement (average k = 0.29 and 0.36, respectively). This study used photographic slides and it may be problematic generalising these results to clinical practice. Discussion Despite the comprehensive search strategy used for this review, publication bias is still possible, and small studies of dermatoscopy with negative results may not have been submitted or accepted for publication. For dermatologists working within specialist clinics the evidence on dermatoscopy is: When sensitivity and specificity are low for clinical diagnosis of melanoma (50%-60%), both are improved by dermatoscopy performed by formally trained experts. However, when sensitivity and specificity are high for clinical diagnosis (84%-95%), dermatoscopy adds little or nothing to either. Improvement in diagnostic accuracy is most apparent for equivocal pigmented skin lesions and when using explicit structured criteria. However, as none of the studies were conducted in a primary care setting, the place of dermatoscopy in general practice is unknown. In addition, none of the studies commented that dermatoscopy improved the sensitivity and specificity of diagnosis enough to alter the clinical management of the pigmented skin lesion. In fact, dermatoscopy only increased the accuracy of diagnosis of equivocal lesions that were to undergo biopsy anyway. Given the low threshold clinicians already have for excision biopsy, the modest impact of dermatoscopy on likelihood ratios suggests it does not improve diagnostic accuracy enough to alter clinical management of most pigmented skin lesions. Further research is currently being undertaken using dermatoscopy to describe the sensitivities and specificities of individual features of pigmented lesions.6 This may prove to be more clinically relevant in the long term. In one study, the use of dermatoscopy by untrained dermatologists resulted in more melanomas being missed than with magnification alone. Non-experts also showed more interobserver and intraobserver variation. This suggests that the benefits of dermatoscopy depend on training and experience with its use. However, none of the studies commented on the type of training needed to develop competence. Two of the studies investigated the effect of using defined diagnostic criteria in diagnosing melanoma. Their results were consistent with the view that simple structured explicit criteria, such as ABCD criteria, either with or without dermatoscopy, result in a high sensitivity and specificity for diagnosis of melanoma. To provide better evidence on the value of dermatoscopy in Australian clinical practice, future research should be more explicit in the methods used and should select lesions representative of those seen in primary and secondary care in Australia. An investigation in clinical practice, where the prevalence of melanoma is low, is not practicable. However, it would be possible to compare the accuracy of diagnosis from dermatoscopic and standard magnified images of skin lesions by dermatologists and general practitioners. This type of study would also allow further assessment of intraobserver and interobserver variability and could be combined with assessment of the impact of training. This approach would allow the potential clinical benefits and limitations of dermatoscopy to be more clearly understood. Acknowledgements I gratefully thank Dr P S Morris (Menzies School of Health Research, Darwin, NT), Associate Professor L Piterman (Department of Community Medicine, Monash University, Melbourne, VIC), and three anonymous reviewers for helpful comments on an earlier draft of the manuscript; Mariella Stroschio and Antje Haase for translation of Italian and German articles; the RACGP Resource Centre librarians, Jane Ryan and Diane Horrigan, for their skills in searching Embase and hard work in locating the articles; the Royal Darwin Hospital library for use of Medline ; and the RACGP Research and Development Fund. References Kelly JW. Malignant melanomas -- how many have you missed? Med J Aust 1996; 164: 431-436. Kelly JW. Melanoma: detection and management. Aust Fam Phys 1994; 23: 801-812. Del Mar CB. How many melanomas have I missed? Is this the question? [letter]. Med J Aust 1996; 165: 456. Nachbar F, Stoltz W, Merckle T, et al. The ABCD rule of dermatoscopy. High prospective value in diagnosis of melanocytic lesions. J Am Acad Dermatol 1994; 30: 551-559. Kenet R, Kang S, Kenet BJ, Fitzpatrick TB. Clinical diagnosis of pigmented lesions using digital epiluminescence microscopy grading protocol. Arch Dermatol 1993; 129: 157-174. Menzies SW, Ingvar C, McCarthy WH. A sensitivity and specificity analysis of the surface microscopy features of invasive melanoma. Melanoma Res 1996; 6: 55-62. Irwig L, Toteson A, Gatsonis C, et al. Guidelines for meta-analyses evaluating diagnostic tests. Ann Intern Med 1994; 120: 667-676. Cochrane Methods Working Group on Systematic Review of Screening and Diagnostic Tests. The Cochrane methods working group on systematic review of screening and diagnostic tests: recommended method. [sighted 6 Oct 1996] < http://som.flinders.edu.au/FUSA/COCHRANE/cochrane/sadt.doc.html > > Nilles M, Boedeker RH, Schill WB. Surface microscopy of naevi and melanomas -- clues to melanoma. Br J Dermatol 1994; 130: 349-355. Carli P, De Georgi V, Donati E, et al. La microscopia a epilumescenza (ELM) riduce il rischio di asportare lesioni melanocitarie clinicamente sospette ma istologicamente comuni. Giornale Italiano Dermatologia e Venereologia 1994; 129: 599-605. Sackett DL, Haynes RB, Guyatt GH, et al. Clinical epidemiology: a basic science of clinical medicine. 2nd ed. Boston, Mass: Little, Brown and Company, 1991: 151-152. Steiner A, Pehamberger H, Wolff K. In vivo epiluminescence microscopy of pigmented skin lesions. 2. Diagnosis of small pigmented skin lesions and early detection of malignant melanoma. J Am Acad Dermat 1987; 17: 584-591. Cristofolini N, Zumiani G, Bauer P, et al. Dermatoscopy: usefulness in the differential diagnosis of cutaneous pigmentary lesions. Melanoma Res 1994; 4: 391-394. Binder N, Schwarz N, Winkler A, et al. Epiluminescence microscopy. A useful tool for the diagnosis of pigmented lesions for formally trained dermatologists. Arch Dermatol 1995; 131: 286-291. Soyer HP, Smolle J, Leitinger G, Kerl H. Diagnostic reliability of dermoscopic criteria for detecting malignant melanomas. Dermatology 1995; 190: 25-30. Pazzini C, Pozzi M, Betti R, et al. Improvement of diagnostic accuracy in the clinical diagnosis of pigmented skin lesions by epiluminescence microscopy. Skin Cancer 1996; 11: 159-161. Pehamberger H, Steiner A, Wolff K. In vivo epiluminescence microscopy of skin lesions. 1. Pattern analysis of pigmented skin lesions. J Am Acad Dermat 1987; 17: 571-583. McGovern TW, Litaker MS. Clinical predictors of malignant pigmented lesions. J Dermatol Surg Oncol 1992; 18: 22-26. Stoltz W, Holzel D, Riemann A, et al. Multivariate analysis of criteria given by dernatoscopy for the recognition of melanocytic lesions [abstract]. Abstracts of the Fiftieth Meeting of the American Academy of Dermatology; 1991; Dallas (TX). American Academy of Dermatology, 1991. Bahmer FA, Fritsch P, Kreusch J, et al. Terminology in surface microscopy. J Am Acad Dermat 1990; 23: 1159-1162. Stoltz W, Riemann A, Armand B, et al. ABCD rule of dermatoscopy: a new practical method for early recognition of malignant melanoma. Eur J Dermatol 1994; 4: 521-527. Lightstone A, Kopf A, Garfinkel L. Diagnostic accuracy -- a new approach to its evaluation: results in basal epitheliomas. Arch Dermatol 1965; 91: 497-501. Jaescheke R, Guyatt GH, Sackett DL. Users guide to the medical literature. 3. How to use an article about a diagnostic test: B. What are the results and will they help me in caring for my patients? JAMA 1994; 271: 703-707. Krieger N, Hiatt RA, Sagebiel RW, et al. Inter-observer variability among pathologists' evaluation of malignant melanoma: effects upon an analytic study. J Clin Epidemiol 1994; 47: 897-902. de Wit PEJ, van't Hof-Grootenboer B, Ruiter DJ. Validity of the histopathological criteria used for diagnosing dysplastic naevi. Eur J Cancer 1993; 29a: 831-839. (Received 14 Nov 1996, accepted 16 May 1997) Authors' details Danila Dilba Medical Service, Darwin, NT. Justine Mayer, FRACGP, General Practitioner; Master of Family Medicine Student (Monash University, Melbourne, VIC). Reprints will not be available from the author. Correspondence: Dr Justine Mayer, PO Box 538, Nightcliff, NT 0814. E-mail: jmayer@racgp.org.au ©MJA 1997 <URL: http://www.mja.com.au/> © 1997 Medical Journal of Australia.

Justine Mayer

Do all Australian women with breast cancer have access to "best practice" in surgical management? Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia". Breast cancer is the commonest internal malignancy among women in Australia. It is increasing in incidence and is expected to continue to do so.1 However, on a positive note, there have been real advances in diagnosis, treatment and psychosocial care of women with breast cancer, and mortality from breast cancer remains stable and is expected to fall.2 A particular advance was the results of randomised clinical trials in the mid 1980s3 which definitively showed that breast-conserving surgery followed by breast irradiation produced much better cosmetic results than mastectomy, without compromising rates of metastasis or survival. Breast-conserving surgery is now an accepted part of "best practice" treatment for most women with early breast cancer, and the National Health and Medical Research Council (NHMRC) has produced guidelines4 on its use. How can we ensure that "best practice" surgical management is available to all Australian women with breast cancer? There has been concern that breast-conserving surgery may not be available to all Australian women. A Victorian survey found that rates of breast-conserving surgery, despite rising from 23% to 43% between 1986 and 1990, were lower among women in non-metropolitan Victoria than among metropolitan women and for surgeons who treated fewer patients with breast cancer per annum.5 In this issue of the Journal, Craft and colleagues provide national data on patterns of breast cancer surgery. Their survey of Medicare data for 1993 found that breast-conserving surgery was undertaken in 39.9% of women reimbursed for breast cancer surgery, but that frequency varied significantly between rural and urban women (33.9% versus 41.9%) and between States (from 33.8% in Western Australia to 49.2% in South Australia/Northern Territory). Similar variations in frequency of breast-conserving surgery have been seen in the United States.6,7 How can we account for these differences? Craft and colleagues suggest that accessibility of radiotherapy services, which are generally located in or near capital cities, may affect a patient's decision to have breast-conserving surgery, although the Victorian survey suggested this is important in only 8% of cases.5 Furthermore, the rate of breast-conserving surgery in a particular rural Victorian practice between 1992 and 1995 was found to be 68%.8 These results suggest that the individual surgeon's attitude still plays an important part in the decision. In drawing conclusions from this study, its limitations must be considered. Craft and colleagues claim to have identified about 60% of the predicted number of women with breast cancer treated in 1993, but these included only patients treated on a fee-for-service basis and therefore excluded all non-insured patients treated in public hospitals. A consistent difference between public and private patients would limit the significance of the results. The study also found that frequency of breast-conserving surgery decreased significantly with patient age. However, this result may not be accurate as the study selection criteria excluded lumpectomy if it was not accompanied by axillary dissection or radiotherapy. It is suspected that radiotherapy is more likely to be omitted -- often inappropriately -- after breast-conserving surgery in older women, many of whom receive follow-up treatment with tamoxifen alone. Unfortunately, the study provides no information on this. Despite these limitations, the rates of breast-conserving surgery reported by Craft and colleagues are low in comparison with estimates that about 70% of mammographically detected cancers and 50% of clinically detected tumours are suitable for breast conservation.4 For example, rates exceeding 50% are routinely reported in metropolitan centres and higher rates have been reported by individuals (e.g., Tulloh and Goldsworthy8). How can we ensure that "best practice" surgical management is available to all Australian women with breast cancer? In the mid 1990s, public and medical concern led the National Breast Cancer Consensus Conference9 and the House of Representatives Standing Committee on Community Affairs10 to recommend the development of evidence-based clinical practice guidelines. The NHMRC guidelines on management of early breast cancer4 were published in November 1995 and disseminated widely by the National Breast Cancer Centre (NBCC). However, other measures may be needed. The Royal Australasian College of Surgeons (RACS) has recognised the need for ongoing training and continuing education and reaccreditation programs for surgeons. For rural women, a regional multidisciplinary team approach is encouraged, as exemplified in the report of breast cancer management in a Victorian country town, where formal links existed with the oncology unit at a Melbourne hospital.8 current data suggest that the survival of patients with breast cancer is better if they are treated by a specialist who also treats a large number of similar patients More extreme measures, such as passing legislation requiring surgeons to disclose options for the treatment of breast cancer, have been tried in the United States. However, this had only a slight and transient effect on rates of breast-conserving surgery, possibly via increased public awareness through publicity about the new legislation, and rates less than 25% were still reported in the US in 1990.7 It is not yet known how far the strategies already in place have overcome problems such as those identified by Craft and colleagues and satisfied the House of Representatives' goal that "the Australian woman who is faced with dealing with breast cancer, regardless of where she lives and whatever her social and economical background, should have the very best treatment and support available".10 To determine the impact of the NHMRC guidelines, the NBCC commissioned a national survey of patients identified through the State cancer registries before the guideline launch. This survey will capture over 90% of patients and provide information on the reasons for choice of treatment options and on surgeon workloads. This is important as current data suggest that the survival of patients with breast cancer is better if they are treated by a specialist who also treats a large number of similar patients, and who has access to the full range of treatment options in a multidisciplinary setting.4,11 As accurate figures on the pattern of surgical care of women with breast cancer become available, better planning and distribution of resources for educating physicians and surgeons about breast cancer may be possible. This would provide women with a greater variety of treatment options and more involvement in decision-making about their care. If necessary, specific educational programs may also be directed at minority patient groups, such as those of a non-English-speaking background, and subgroups, such as rural patients, elderly patients and the disadvantaged. Best practice in the surgical management of breast cancer has come a long way in the past 20 years, and with increased patient involvement in management decisions and a well-educated multidisciplinary team new treatment advances will rapidly find their way into day-to-day clinical practice. John P Collins Head, Breast Unit, Royal Women's Hospital; and Surgeon, Royal Melbourne Hospital,Melbourne, VIC. Commonwealth Department of Human Services and Health. Better health outcomes for Australians. Canberra: The Department, 1994. Taylor R, Smith D, Hoger A, et al. Breast cancer in NSW. Sydney: Cancer Epidemiology Research Unit, NSW Cancer Council, 1994. Fisher B, Bauer M, Margolese R, et al. Five-year results of a randomized clinical trial comparing total mastectomy and segmental mastectomy with or without radiation in the treatment of breast cancer. N Engl J Med 1985; 312: 665-673. National Health and Medical Research Council. Clinical practice guidelines: the management of early breast cancer. Canberra: NHMRC/AGPS, 1995. Hill DJ, White VM, Giles GG, et al. Changes in the investigation and management of primary operable breast cancer in Victoria. Med J Aust 1994; 161: 110-122. Farrow DC, Hunt WC, Samet JM. Geographic variation in the treatment of localised breast cancer. N Engl J Med 1992; 326: 1097-1101. Nattinger AB, Hoffmann RG, Shapiro R, et al. The effect of legislative requirements on the use of breast-conserving surgery. N Engl J Med 1996; 335: 1035-1040. Tulloh BR, Goldsworthy ME. Breast cancer management: a rural perspective. Med J Aust 1997: 166; 26-29. Breast cancer consensus report. Med J Aust 1994; 161 Suppl 7: S1-S16. House of Representatives Standing Committee on Community Affairs. Report on the management and treatment of breast cancer in Australia. Canberra: AGPS, 1995. Sainsbury R, Howard B, Rider L, et al. Influence of clinician workload and patterns of treatment on surviving from breast cancer. Lancet 1995; 345: 1265-1270.

John P Collins

Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia". Abstract - Introduction - Methods - Data source - Study design - Analysis by demographic characteristics - Results - Discussion - Acknowledgements - References - Authors' details Abstract Objective: To examine patterns of surgical management of breast cancer among Australian women. Design: Retrospective survey of Medicare records (a national dataset of all services rendered on a "fee-for-service" basis for which a Medicare benefit has been paid). Patients: All Australian women (4683) who underwent surgery consistent with being for breast cancer in 1993 and for which Medicare benefits were paid. Main outcome measures: Proportions of women undergoing different forms of mastectomy, breast-conserving surgery and axillary surgery by patient age and State and region (urban or rural) of residence. Results: Modified radical mastectomy was the most common surgery, performed in 2097 of the 4683 women (44.8%), while 1868 (39.9%) had breast-conserving surgery. Frequency of breast conservation decreased significantly with age and varied significantly between States and region of residence. It ranged from 34% in Western Australia to 49% in South Australia and the Northern Territory, and from 34% among rural women to 42% among urban women. Axillary surgery was recorded for 83% of all women studied. Conclusions: There was substantial geographical variation in patterns of surgical management for breast cancer. The tendency for rural women to undergo mastectomy rather than breast-conserving surgery may reflect the relative lack of access to postoperative radiotherapy. We are unable to explain the variation between States. MJA 1997; 166: 626-629 Introduction Breast cancer is the commonest malignancy among Australian women after non-melanocytic skin cancer and is the commonest cause of cancer deaths in women.1 Until recently, the optimal management of breast cancer that is limited to the primary site (with or without axillary nodal involvement) was unclear, with some advocating routine mastectomy and others advocating a breast-conserving approach for selected patients. After randomised controlled clinical trials, a consensus has emerged that most patients with Stage I and II carcinoma of the breast (comprising about 80% of patients presenting with breast cancer) can be managed with a breast-conserving approach, with rates of local and regional control and survival equivalent to those obtained with mastectomy.2-6 Breast-conserving treatment also seems less disturbing to perceived body image and sexuality than mastectomy.7 Surgical management of breast cancer has been found to vary significantly between different population groups in the United States.8,9 We investigated surgical management of Australian women treated for breast cancer by analysing Medicare records, and assessing variations in management by patient age and State and region (urban or rural) of residence. Methods Data source Medicare statistics were obtained from the Commonwealth Department of Health and Family Services. They contain details of services rendered on a "fee-for-service" basis for which Medicare benefits were paid. They exclude services to public patients in hospitals and to Veterans' Affairs patients, and services for injuries that are eligible for compensation, unless an interim Medicare benefit is paid. Study design All women who received at least one Medicare benefit for surgical items on the Medicare Benefits Schedule (MBS) consistent with breast cancer surgery during the 1993 calendar year were included. These items comprised mastectomy -- simple, partial, extended simple, subcutaneous, modified radical an d radical -- and excision of a breast lump if followed by axillary dissection and/or radiotherapy. Medicare records for the first two quarters of 1994 were also examined to ensure that all subsequent episodes of breast surgery or radiotherapy were captured. It was assumed that very few patients would receive these treatments for non-malignant breast disease. Women who had had only excision of a breast lump but no radiotherapy or axillary dissection were excluded. Data recorded in addition to surgical procedure(s) were the date of service, and patient's personal identification number (PIN), date of birth, sex and postcode of residence. The identity of each person in the study was protected by a PIN which could not be decoded by the investigators. Analysis by demographic characteristics Patient age in 1993 was determined from year of birth, and State and region of residence from postcode. Postcodes were classified into regional zones according to the Rural, remote and metropolitan areas classification 1991 census edition.10 When a postcode extended into two regions, a factor based on population density was used to determine in which region it would be placed. To provide sufficient numbers for analysis in each State group, data were combined for the Australian Capital Territory (ACT) and New South Wales (NSW) and for the Northern Territory (NT) and South Australia (SA). Proportions were compared with the chi-squared test. Logistic regression analysis was performed with SPSS version 6.1.11 Results We identified 4683 women who received at least one Medicare benefit for surgical items consistent with breast cancer surgery in 1993. These represented 58% of the 8100 expected incident cases of female breast cancer in Australia in this year.1 Surgical procedures performed are summarised in Box 1 (below). Some form of total mastectomy was performed in 2815 women (60.1%), while surgery consistent with breast conservation was performed in 1868 (39.9%). The most frequently identified definitive surgical procedure was radical or modified radical mastectomy, with 2097 services recorded. It was the only surgical therapy in 1265 women, but was accompanied by other surgical items in 832. Patterns of surgery in different patient age groups are summarised in Box 2 (below). Breast-conserving surgery was most frequent in women aged less than 60 years, with the frequency falling to 32% in women aged 70 to 79 years. Variation in type of surgery by age was highly significant (chi-squared for trend = 16.3; P < 0.001). Frequency of breast-conserving surgery was significantly higher among women resident in urban regions than among those resident in rural regions (comprising large rural towns, rural areas and remote areas). Breast conservation was undertaken in 1462 of 3483 urban women (41.9%), but in only 397 of 1170 rural women (33.9%) (chi-squared = 23.3; P < 0.001). The frequency did not differ between women resident in large rural towns, in rural areas and in remote areas. The residential area of 30 women could not be classified. Patterns of surgery also varied significantly between States (Box 3), with breast-conserving surgery performed in 49.2% of those resident in SA and the NT, but in only 33.8% of those resident in Western Australia (WA). Multivariate analysis showed that this variation was not caused by State differences in population distribution between urban and rural areas. The axilla was treated surgically, either as part of a mastectomy or under specific axillary dissection MBS items, in 3889 women (83.0%). Frequency of axillary surgery was similar in most age groups, except those aged 80 years or older (Box 2). In this group, only 62.8% of women underwent axillary dissection versus 84.1% of women aged less than 80 years (chi-squared = 70.0; P < 0.001). Frequency of axillary surgery varied slightly between States, with WA having the highest rate and Tasmania the lowest (Box 2), but did not differ between urban and rural residents (2892 of 3483 [83.0%] urban residents and 970 of 1170 [82.9%] rural residents). Discussion We found that breast-conserving surgery was performed in almost 40% of Australian women undergoing breast cancer surgery reimbursed by Medicare in 1993. However, the proportion who underwent breast-conserving surgery tended to decrease with patient age and varied significantly beween States and between rural and urban women. Our results are similar to those of other studies of surgical care for breast cancer in Australia. In WA, Byrne et al. found that breast-conserving surgery was used in 29.4% of all women treated for breast cancer in 1989, and in 31.3% of those with "potentially eligible" tumours,12 compared with a figure of 33.7% for WA in our study. In NSW in 1988-1991, breast-conserving surgery was used to treat 40% of a series of 105 mammographically detected tumours,13 while a six-month survey of Victorian surgeons in 1990 found that breast conserving surgery was performed in 42% of cases of operable breast cancer.14 We found significant geographical variation in the proportion of women receiving breast-conserving surgery reimbursed by Medicare. Women living in rural or remote locations were more likely to undergo mastectomy. Breast conservation usually necessitates postoperative radiotherapy, and, as radiotherapy services are often not conveniently located for rural populations, this treatment can involve considerable social and financial costs to patients, which may influence the decision to undergo mastectomy. The proportion of women undergoing breast-conserving surgery also varied between States. This variation was not explained by differences between populations, such as proportions of women living in rural and urban regions. The reasons for this are unclear, but preference for mastectomy versus breast-conserving surgery among surgeons and women may vary between States, explaining the observed differences. Older women were less likely to have breast-conserving treatment. Similar patterns have been observed in surveys of breast cancer management.7 Some older women might reasonably prefer to avoid radiotherapy and be relatively less concerned about mastectomy. Alternatively, as the study could not detect women with breast cancer who had had only excision of the primary tumour but neither axillary dissection nor radiotherapy, if this treatment was more common in older patients, then the frequency of breast conservation may have been underestimated. The rates of axillary surgery were generally high and relatively uniform across age groups and between States and regions. Treatment of the axilla is not recommended for in-situ disease15 and may reasonably be withheld for a small invasive cancer, particularly in older women, possibly explaining the omission of axillary dissection for a proportion of study patients.16 Our study, using data collected routinely for administrative purposes, has several advantages over special purpose surveys. These include timeliness, economy, objectivity and standardisation of data recording. In addition, such a study offers the possibility of examining trends in service delivery over time by means of repeated reviews. Special purpose surveys usually rely on healthcare providers to donate their own, or staff, time to complete the survey instrument, which can be a problem for both researchers and healthcare providers. However, a review based on administrative datasets has some limitations. It can provide only descriptive information and does not give insight into the reasons for disease management decisions. As subjects were identified by interpreting MBS items from Medicare records, the presence of an underlying diagnosis of breast cancer was inferred and not independently verified -- for example, by data matching. Therefore, no information was available about clinical or pathological features of the tumours (e.g., stage and size of primary tumour), which would have influenced the choice of surgical management. In addition, some women who underwent surgery for a breast neoplasm other than carcinoma, or for benign disease, may have been included as subjects. We believe that these instances would be rare, and that the vast majority of cases represented women with primary carcinoma of the breast or carcinoma-in-situ. It was also assumed that patients who had one procedure performed on a private "fee-for-service" basis would have subsequent related services provided on the same basis. However, if substantial numbers of women with breast cancer moved to the public hospital system for part of their surgical management, then this study would have underestimated the frequency of subsequent, more extensive, surgery. This might have led to underestimation of the frequency of mastectomy and axillary dissection, and could have had a variable effect between regions because of differences in private health insurance rates. Guidelines for the treatment of early breast cancer have been published recently and are expected to improve standards of care and treatment,6 and to reduce variability in clinical practice. However, the optimal ratio of mastectomies to breast conserving-surgery in Australia remains unknown. Ultimately, the choice of treatment is a decision taken by each individual, informed by advice from her surgeon and information from other sources. Secondary analyses of data collected for reimbursement purposes, such as in our study, can shed no light on such decisions. Detailed surveys of patterns of care should be undertaken and deserve the support of the medical community. Acknowledgements We wish to thank the Medicare Statistics Section of the Department of Health and Family Services for the data supplied within this report. Special thanks to David Wong for his assistance in supplying data. References Jelfs P, Coates M, Giles G, et al. Cancer in Australia 1989-1990 (with projections to 1995). Canberra: Australian Institute of Health and Welfare, 1996: 7-16. Cancer Series No. 5. Jamrozik K, Byrne MJ, Fitzgerald CJ, et al. Breast cancer in Western Australia in 1989. I. Presentation. Aust N Z J Surg 1993; 63: 617-623. Fisher B, Bauer M, Margolese R, et al. Five year results of a randomised clinical trial comparing total mastectomy and segmental mastectomy with or without radiation in the treatment of breast cancer. N Engl J Med 1985, 312: 665-673. Veronesi U, Luini A, Del Vecchio M, et al. Radiotherapy after breast-preserving surgery in women with localized cancer of the breast. N Engl J Med 1993; 328: 1587-1591. Blichert-Toft M. A Danish randomised trial comparing breast conservation with mastectomy in mammary carcinoma. Br J Cancer 1990; 62 Suppl 12: S15. National Health and Medical Research Council. Clinical practice guidelines. The management of early breast cancer. Canberra: AGPS, 1995: 46-50; 133-162. Kiebert GM, de Haes JCJM, van de Velde CJH. The impact of breast-conserving treatment and mastectomy on the quality of life of early-stage breast cancer patients: a review. J Clin Oncol 1991; 9: 1059-1070. Samet JM, Hunt WC, Farrow DC. Determinants of receiving breast-conserving surgery. The surveillance, epidemiology and end results program 1983-1986. Cancer 1994; 73: 2344-2351. Nattinger AB, Goottlieb MS, Veum J, et al. Geographic variation in the use of breast-conserving treatment for breast cancer. N Engl J Med 1992; 326: 1102-1107. Department of Primary Industries and Energy and Department of Human Services and Health Rural, remote and metropolitan areas classification 1991 census edition. Canberra: the Departments, 1994. SPSS Inc. Statistical package for the social sciences [computer program]. Version 6.1. Chicago, III: SPSS Inc, 1994. Byrne MJ, Jamrozik K, Parsons RW, et al. Breast cancer in Western Australia in 1989. II. Diagnosis and primary management. Aust N Z J Surg 1993; 63: 624-629. Harrison RI, Glenn DC, Niesche FW, et al. Surgical management of breast cancer. Experience of the Central Sydney Health Service Breast X-ray Programme, 1988-1991. Med J Aust 1994; 160: 617-620. Hill DJ, White VM, Giles GG, et al. Changes in the investigation and management of primary operable breast cancer in Victoria. Med J Aust 1994; 161: 110-122. Balch CM, Singletary E, Bland KI. Clinical decision-making in early breast cancer. Ann Surg 1993; 217: 207-255. Silverstein MJ, Gierson ED, Waisman JR, et al. Axillary lymph node dissection for T1a breast c arcinoma. Cancer 1994; 73: 664-669.(Received 6 Sep 1996, accepted 3 Mar 1997) Authors' details Medical Oncology Unit, Canberra Hospital, Canberra, ACT. Paul S Craft, MPH, FRACP, Director. Commonwealth Department of Health and Family Services, Woden, ACT. John G Primrose, FRACR, Senior Medical Advisor; Julie A Lindner, Computer Analyst, Drug Utilization Sub-Committee Secretariat; Peter R McManus, BPharm, MMedSc, Secretary, Drug Utilization Sub-Committee of the Pharmaceutical Benefits Advisory Committee. No reprints will be available. Correspondence: Dr P S Craft, Medical Oncology Unit, Canberra Hospital, Canberra, ACT 2607. E-mail: PAUL_CRAFT@dpa.act.gov.au

Paul S Craft · John G Primrose · Julie A Lindner · Peter R McManus

Can "best practice" be achieved outside metropolitan centres? Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". About five million Australians (almost 30% of the population) live outside metropolitan centres, in regional towns or more remote areas. Providing good health care for these people, spread over such a large area, has always been a challenge. Recently, concern has focused on access to general practitioner services in rural and remote areas, but access to specialist care is equally important. Surgeons in rural areas, unlike their metropolitan counterparts, are responsible for a broad range of surgical care and do not have the opportunity to concentrate exclusively on a narrow field of practice, such as breast surgery. In recognition of this, the Royal Australasian College of Surgeons (RACS) has established a Division of Rural Surgery, which provides a forum for discussion of rural surgical services and continuing medical education for surgeons who live and work at a distance from major teaching institutions. the expertise of a local specialist who understands the circumstances and needs of patients living in remote areas is invaluable in planning treatment Treatment of breast cancer in Australia has been extensively discussed recently, and a recent report 1 has emphasised the need for multidisciplinary management in centres which are, of necessity, in urban areas. However, a recent South Australian study showed that almost 25% of breast cancers occur in women who live outside urban areas, 2 and there are about 1.5 million women at risk of breast cancer in country areas (calculated from Australian Bureau of Statistics data for women aged over 30 years). BreastScreen Australia, which operates in every State and Territory, plans to screen about a third of these (including 70% of women aged 50-69 years), so that many new, early breast cancers will eventually be detected in rural women. Nevertheless, there is little information about the treatment of breast cancer in rural areas. Tulloh and Goldsworthy's study of breast cancer management in a Victorian country town (in this issue of the Journal) provides valuable information for the debate on how best to deliver treatment to women in rural areas. There is abundant evidence that breast-conserving surgery achieves disease control with good cosmesis in many breast cancer patients. No studies have shown any difference in long term survival rates between women who have had breast-conserving surgery and those who have had a mastectomy for a similar type and stage of disease, and breast-conserving surgery is widely accepted as the preferred treatment for early-stage breast cancer. 3 However, there is substantial geographic variation in the use of breast conservation as standard treatment in both Australia and the United States, 4,5 and there is concern that time, travel and communication may prove obstacles to such treatment in rural areas. Tulloh and Goldsworthy show that this need not be so. Experience at metropolitan centres in Australia shows that more than 50% of primary breast cancers are now treated conservatively; Tulloh's index of 68% is higher. Concern has also been expressed that limited experience in surgical management of breast cancer may be an impediment to "best practice". As recently as 1986, 25% of surgeons who treated breast cancer in Victoria treated fewer than five cases a year. 6 While most urban surgeons now agree that breast cancer should be treated in a multidisciplinary setting by a specialist who treats many breast cancers, almost 50% of rural surgeons believe this is not necessary (National Health and Medical Research Council National Breast Cancer Centre and RACS Joint Study, personal communication from Dr S Redman, Director, National Breast Cancer Centre, Sydney, NSW). This may be an issue for training of surgeons: those who have had appropriate experience during their higher surgical training are likely to retain competence, despite a relatively small workload. Training in breast surgery has been greatly improved by the development of specialist surgical breast units in metropolitan teaching hospitals. In addition, the establishment of reaccreditation and continuing education programs within the RACS ensures that every surgeon who practises breast surgery has the opportunity to be informed of new treatment developments. Although the rate of surgical complications reported by Tulloh was higher than would be expected for a specialist surgeon (those who treat more than 100 breast cancers a year would rarely see skin-flap necrosis after a mastectomy and would expect a haemotoma rate of 2%-3% after open biopsy), such rates are acceptable in a general surgical practice. The benefits of multidisciplinary management of breast cancer have been debated for some time. Multidisciplinary units in metropolitan centres are justified by their logistic advantages, by the opportunity to establish high standards with consistent peer review and by the small, but demonstrable, improvement in outcome. 7,8 The National Health and Medical Research Council clinical guidelines 9 espouse the principle of multidisciplinary care, but also point out that this can be achieved outside integrated treatment centres, by consultation between appropriate specialists. Tulloh and Goldsworthy have demonstrated that this can be done efficiently. Cost and logistics prevent the establishment of rural radiation treatment centres, but many medical and radiation oncologists visit regional centres for consultations and treatment planning. Electronic communication between rural and metropolitan centres can also facilitate multidisciplinary management. In this context, the expertise of a local specialist who understands the circumstances and needs of patients living in remote areas is invaluable in planning treatment. Australians who live in cities sometimes believe that those who live in the country accept that access to some components of health care is restricted. The determination of rural specialists and nurses like Tulloh and Goldsworthy to demonstrate that high standards of care, comparable to those in urban Australia, can be achieved in rural centres is an example to all health professionals. In addition, their demonstration that breast cancer can be managed effectively in rural centres serves as a model for other cancers and shows that, with effective communication, there is no insuperable barrier to high standards of health care in rural Australia. Colin M Furnival Senior Visiting Specialist, Surgical Breast Unit Royal Brisbane Hospital, QLD. House of Representatives Standing Committee on Community Affairs. Report on the management and treatment of breast cancer in Australia. Canberra: AGPS, 1995. South Australian Cancer Registry. Epidemiology of cancer in South Australia. Adelaide: The Cancer Registry, 1996: 211-236. Harries SA, Lawrence RN, et al. A survey of the management of breast cancer in England and Wales. Ann R Coll Surg Engl 1996; 78: 197-202. Byrne MJ, Jamrozik K, Parsons RW, et al. Breast cancer in Western Australia in 1989. II. Diagnosis and primary management. Aust N Z J Surg 1993; 63: 624-629. Farrow DC, Hunt WC, Samet JM. Geographic variation in the treatment of localised breast cancer. N Engl J Med 1992; 326: 1097-1101. Hill DJ, Giles GG, Russel IS, et al. Management of primary, operable breast cancer in Victoria. Med J Aust 1990; 152: 67-72. Sainsbury R, Haward B, Rider L, et al. Influence of clinician workload and patterns of treatment on surviving from breast cancer. Lancet 1995; 345: 1265-1270. Gillis CR, Hole DJ. Survival outcome of care by specialist surgeons in breast cancer: a study of 3786 patients in the west of Scotland. BMJ 1996; 312: 145-148. National Health and Medical Research Council. The management of early breast cancer. Clinical practice guidelines. Canberra: NHMRC/AGPS, Oct 1995.

Colin M Furnival

Audit of a general surgical practice in the rural Victorian town of Echuca identified 28 new patients with breast cancer between September 1992 and August 1995 (10% of those with breast conditions). The rural setting was no impediment to breast conservation (achieved in 68% of the 25 who had surgery) or to a multidisciplinary approach (management was planned in conjunction with an oncologist and/or specialist breast surgeon for 26 of the 28 patients). Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia". Introduction - Setting - Patients - Surgical treatment - Specialist liaison - Other treatment - Complications - Long-term outcome - Discussion - Acknowledgements - References - Authors' details Introduction Carcinoma of the breast is a major public health issue at present. It has been the subject of two Government inquiries, 1,2 the more recent of which suggested that management of breast cancer across Australia was fragmented, uncoordinated and, at least in some areas, out of date. 1 The National Breast Cancer Centre 3 was established recently, with the mission of ensuring the highest standard of care for all Australian patients with breast cancer. The National Health and Medical Research Council has published guidelines to assist both patients 4 and doctors 5 in achieving this aim. These publications indicate that breast cancer management is highly specialised and imply that it is best done in major metropolitan centres where multidisciplinary expertise is available on-site. However, the need for specialised centres for breast cancer management is questionable. 6 Submissions from rural women to the Government inquiriesdescribed the increased burden imposed on them and their families in travelling for treatment and their consequent lack of treatment choices. 3 Many country people prefer local treatment and expect that their local hospital will provide the highest standard of care. However, to our knowledge there have been no publications on how breast cancer is managed in Australian rural centres. To provide this information, we conducted a three-year survey of breast cancer management in the practice of a general surgeon (B R T) in the rural Victorian town of Echuca. Setting Echuca is in northern Victoria, about 200 km from the capital, Melbourne. It has a 64-bed general hospital, which serves the town's population of about 15 000 and another 20 000 people in surrounding farming districts. During the survey period, formal links were in place with the oncology unit at St Vincent's Hospital, Melbourne, whose specialists regularly visited the regional base hospital at Shepparton, about 80 km from Echuca. More recently, the Bendigo Hospital, about 100 km away, has appointed a full-time medical oncologist, who now consults monthly at Echuca. These links have been important for interdisciplinary communication, as well as facilitating patient referral for radiotherapy (available in Melbourne) when required. Histology and cytology services are provided at Shepparton. A daily courier service transports specimens to the laboratory and reports are faxed within 48 hours. Hormone receptor studies on paraffin-embedded material with immunoperoxidase stains are available on request. Patients The study involved review of the medical records of all patients who attended the Echuca Consulting Suites under the care of a general surgeon (B R T) between 1 September 1992 and 31 August 1995. This is the surgeon's only practice location. Both private and uninsured patients were included, as the local hospital has no outpatient clinic. Surgical details were obtained from the surgeon's log book, and details of chemotherapeutic regimens and inpatient management from hospital medical records when required. Between September 1992 and August 1995, there were 1992 new patients (excluding emergencies and in-hospital consultations); 275 (14%) were seen for breast conditions. All of these were referred directly by their general practitioners. Surgery was offered for suspected malignancy and for a palpable breast lump that was either atypical on cytological examination, or was causing undue anxiety to the patient. Eighty-two patients (30% of those with a breast condition) had surgery; 57 had benign disease and 25 had cancer. Of those with cancer, 22 were diagnosed by fine-needle aspiration biopsy, 24 by mammography, and two by open biopsy (some patients had more than one form of test). Three patients with advanced breast cancer did not have surgery, giving a total of 28 with breast cancer (10% of the 275 with a breast condition). To our knowledge, none of the remaining 190 have since developed breast cancer. Nine of the 82 patients undergoing surgery had wire-localised excisions of lesions detected by mammography; four had carcinoma. Surgical treatment Treatment of the 25 patients who underwent surgery for cancer is summarised in the Box. Seventeen patients (68%) were suitable for breast conservation, having relatively small, peripheral tumours in breasts of moderate size. However, eight (32%) required mastectomy: two of these had large central tumours for which local excision would have been disfiguring; two had extensive in-situ components for which local treatment would have been inadequate; two required palliative mastectomy for control of locally advanced primary tumours; one presented with axillary lymphadenopathy alone; and one had pure ductal carcinoma-in-situ. The latter and the two having palliative surgery had simple mastectomies. The other five had modified radical mastectomies, with preservation of the pectoralis minor muscle. Clearance of axillary lymph nodes was undertaken for 15 of the 17 patients who had wide local excision of their primary breast cancers (for 12 this was done in Echuca and for three after they chose to go to Melbourne for further management). Two patients (aged 73 and 76, with tumours of 11 mm and 13 mm diameter, respectively) did not undergo axillary clearance, as it was considered that a positive lymph node yield would not alter their treatment regimen. They were given adjuvant tamoxifen alone. Altogether, 17 axillary clearances were done in Echuca (12 in association with a wide local excision and five with a modified radical mastectomy). The mean lymph node yield for those operated on in Echuca was 13 nodes (range, 4-29). Yields from the three patients who had axillary clearances by breast specialist surgeons in Melbourne were six, eight and 12 nodes, respectively. Specialist liaison Sixteen of the 28 new patients presenting with breast cancer were seen by an oncologist and/or specialist breast surgeon after diagnosis, sometimes before definitive surgery, to formulate a management plan (e.g., to discuss the role of axillary clearance or mastectomy). For a further ten, management plans were devised after telephone discussions with the other specialists. Specialist liaison was not obtained for two patients, as the surgeon was confident that the management plan was appropriate (and as one refused adjuvant therapy). Other treatment Each of the mastectomy patients had counselling and advice on prosthetics from the hospital's oncology nurse (M E G), who is also the prosthetics officer and stomal therapist. Each was invited to discuss referral for breast reconstruction, but so far only one has proceeded with this; she had a delayed transverse rectus abdominis myocutaneous (TRAM) flap reconstruction in Melbourne, with satisfactory results. Adjuvant radiotherapy was given to only nine of the 17 patients who underwent breast-conserving surgery. Seven of the other eight had small primary tumours (up to 12 mm diameter); the decision to omit radiotherapy was made for five of these by the oncologists consulted at the time or, for two, by the patients themselves, who chose not to travel 200 km to Melbourne for treatment. Another patient had undergone chest-wall irradiation in the past and was advised against having more. Twelve patients were referred for chemotherapy; one refused, despite exhaustive discussions with her general practitioner, surgeon and the regional oncologist, and 11 were seen by regional oncologists for planning of the chemotherapeutic regimen. At first, chemotherapy was given by the regional oncologists at Shepparton, but after 1993 it was given by the local oncology nurse (M E G) at Echuca under the supervision of the patient's general practitioner, with indirect supervision by the oncologist in charge. Two patients participated in national chemotherapy trials through the Bendigo Hospital Oncology Department; another patient was invited to participate but declined to do so. Adjuvant hormonal therapy was widely used. All post-menopausal patients with oestrogen receptor-positive tumours were prescribed tamoxifen. The decision to use this in patients with oestrogen receptor-negative tumours was made in conjunction with the regional oncologists. Complications Surgical complications were uncommon. One of the eight mastectomy patients developed superficial skin-flap necrosis, which healed satisfactorily without further surgery. Five of the 57 who underwent lumpectomy for benign disease developed a significant breast haematoma, defined as either a tense blood clot in the biopsy cavity or extensive bruising over the chest wall. Six of the 17 who had axillary clearance of lymph nodes developed seromas in the axilla, which required postoperative needle aspiration. One seroma became infected after aspiration, requiring intravenous antibiotics. Cosmetic results of surgery were acceptable to the patients and surgeon using subjective criteria (e.g., neat scar, no patient complaints). Careful consideration was always given to placement of incisions, design of mastectomy flaps, and use of drainage. 7 Fine absorbable subcuticular closure was used routinely. Long-term outcome Four of the 25 patients who underwent surgery for breast cancer have since died. All had advanced disease. Another patient, who was diagnosed with stage II disease and underwent local excision and chemotherapy, has developed metastatic disease. Discussion Our results show that a rural setting is no impediment to the use of breast-conserving surgery or a multidisciplinary approach in breast cancer management. Management of 26 of the 28 patients with breast cancer was planned in conjunction with an oncologist and/or specialist breast surgeon. Breast conservation was achieved in 68% of the 25 patients who underwent surgery. The frequencies of breast complaints (14% of new consultations) and of breast cancer (10% of breast complaints) in our practice were comparable with those found in two general surgical outpatient clinics in the United Kingdom. 8,9 However, the percentage of breast complaints that came to surgery in Echuca (30%) fell midway between the percentages found at Reading and Newbury in 1993 (16%) 8 and in London in 1982 (45%). 9 These differences could reflect changes in surgical policy with time, as well as differences in local criteria for biopsy. The ratio of benign to malignant lumps excised in Echuca was only 2:1, also midway between the figures for Reading and Newbury (1:1) 8 and for London (3:1), 9 probably for similar reasons. Modes of presentation and distribution across clinical stages in our series were similar to those found in a study of 856 patients with breast cancer from the Victorian Cancer Registry in 1990. 10 This study found that multidisciplinary management and use of breast conserving surgery was more likely for surgeons who treated more than 20 cases a year. In the Echuca series, with fewer than 10 cases a year, multi- disciplinary involvement and breast conservation rates were higher still. These differences reflect the different eras from which these reports have been derived, as breast cancer management strategies changed rapidly in the early 1990s, and make comparision of management strategies difficult to interpret. Are nine breast cancers a year enough for a centre to maintain competence in managing the disease? About 90 new patients with breast conditions (benign and malignant) were seen each year. Assuming each was seen two to four times in the year, there were 250-300 breast examinations per year, allowing expertise in examination to be maintained. Operative technique and complication rates were comparable to peer standards. 11 Management of breast cancer locally has numerous advantages for the country patient, not least of which is convenience. In fact, the travel involved (200 km) led one patient to refuse radiotherapy. On the other hand, local management has few, if any, disadvantages. Surgery for breast cancer is straightforward; more important are the management decisions. While "best practice" may require a multidisciplinary approach, we showed that this can easily be obtained by consultation with city colleagues on a case-by-case basis. Adjuvant therapy and follow-up can usually also be provided locally, provided that communication is maintained with the relevant specialists. Thus, it is important for rural doctors and nurses to keep up to date with trends in breast cancer management, but equally important that city-based centres of excellence encourage rural colleagues to participate in patient care. No patients in this series had their cancers detected by the regional mammographic screening program. Possibly, some patients from the Echuca region were identified in this way, but were referred to surgeons in Melbourne, as has occurred in other rural locations, leading to criticism. 12 However, as the standard of care provided in rural hospitals becomes acknowledged and patients' wishes about treatment location are taken into account, definitive management at local centres should become a policy for screening programs. Each of the potential inadequacies of isolated or small-volume practice (as identified in the House of Representatives Report on the management and treatment of breast cancer in Australia) 1 is addressed at Echuca, as is likely at many other country centres. Although relatively few new breast cancers were detected and treated each year, most were managed in consultation with other specialists. Operative technique and complication rates were comparable to peer standards; cosmetic results were considered satisfactory; patients had access locally to literature about breast cancer and treatment options, supportive counselling, a prosthetics service and chemotherapy and were offered referral for breast reconstruction after mastectomy; and several patients participated in trials of chemotherapy regimens. However, quality assurance was difficult; while surgical morbidity was monitored by the surgeon, formal review of adjuvant therapies' morbidity was lacking and round-table case discussions and histopathological or radiological review sessions were difficult to organise. It remains the responsibility of individual rural practitioners to seek such interdisciplinary contact as part of their continuing medical education. We conclude that a multidisciplinary service of high standard can be provided to patients with breast disease irrespective of their rural location, provided that they are prepared to travel for adjuvant therapy and for second opinions, if warranted. Acknowledgements The authors are indebted to Tamra Wines, Tracey McNair and Lisa Humphrys for their help in retrieving the data. References House of Representatives Standing Committee on Community Affairs. Report on the management and treatment of breast cancer in Australia. Canberra: AGPS, 1995. Senate Standing Committee on Community Affairs. Breast cancer screening and treatment in Australia. Canberra: Senate Printing Unit, 1994. Redman S, Kearsley JH. The National Breast Cancer Centre. Med J Aust 1995; 163: 432-433. National Health and Medical Research Council. Early breast cancer. A consumer's guide. Canberra: NHMRC/AGPS, Oct 1995. National Health and Medical Research Council. The management of early breast cancer. Clinical practice guidelines. Canberra: NHMRC/AGPS, Oct 1995. Ingram D. Who manages breast cancer? Aust N Z J Surg 1996; 66: 133. Dixon JM. Techniques of and indications for breast biopsy. Curr Pract Surg 1993; 5: 142-148. Dawson C, Lancashire MJ, Reece-Smith H and Faber RG. Breast disease and the general surgeon. Referral of patients with breast problems. Ann R Coll Surg Engl 1993; 75: 79-86. Cox PJ, Li MKW, Ellis H. Spectrum of breast disease in outpatient surgical practice. J R Soc Med 1982; 75: 857-859. Hill DJ, White VM, Giles GG, et al. Changes in the investigation and management of primary operable breast cancer in Victoria. Med J Aust 1994; 161: 110-122. Oertli D, Laffler U, Haberthuer F, et al. Perioperative and post-operative tranexamic acid reduces the local wound complication rate after surgery for breast cancer. Br J Surg 1994; 81: 856-859. Allsop JR. Changes in the investigation and management of primary operable breast cancer in Victoria [letter]. Med J Aust 1995; 162: 335. Authors' details Echuca Regional Health, Echuca, VIC. Bruce R Tulloh, MS, FRACS, General Surgeon; Marjorie E Goldsworthy, RN, Oncology Nurse and Breast Prosthetist, Division of Nursing. Reprints: Mr B R Tulloh, Corner of Francis and Leichhardt Streets, Echuca, VIC 3564.

Bruce R Tulloh · Marjorie E Goldsworthy

Cancer and TV towers: association but not causation A more complete knowledge of the causes of childhood leukaemia is essential before progressing from association to causation MJA 1996; 165: 599 Readers may print a single copy for personal use. No further reproduction or distribution of the articles in whole or in part should proceed without the permission of the publisher. For copyright permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". - ©MJA1996 Nothing concentrates public concern more than links -- real or supposed -- between pollution from man-made objects and malignant diseases. This is probably made worse if we do not particularly enjoy the aesthetic appeal of the objects in question, and worse still if we do not understand what the biological effects might be of the pollutants involved. This situation is exemplified by the study by Hocking et al. in this issue of the Journal. They report an excess of leukaemia in people living near the TV towers just north of Sydney, the excesses being mainly in children and in certain time periods. Technically epidemiologists will regard such an observation as an "association" -- that is to say, pretty difficult (if not impossible) to understand in isolation and one which has to be put into context. Is this association in Sydney the product of one of these quirks of distribution? How does one interpret the study of Hocking et al.? Such a question is effectively asking: how can an epidemiological study lead to a causal link being established between radiofrequency irradiation and leukaemia in children? Several informative steps are required. Firstly, is this a new observation? The answer is, nearly but not quite. The authors themselves refer to a rather unsatisfactory study from Honolulu, which might show a non-statistically significant leukaemia excess near radio transmitters. 1 In addition, and potentially more interesting, an extensive study in Britain has shown a nearly twofold excess in leukaemia in residents close to one particular TV transmitter complex -- but only in mixed types of leukaemia in adults and not in children. 2 However, when all the other TV and related radio transmitters in Britain were studied this excess was not confirmed, although a decline in leukaemia incidence with distance from the towers was observed. It should be noted that the adult leukaemias are very different diseases, in terms of causation, from childhood acute leukaemia, 3 as indeed the different types of adult leukaemias are from each other. 4 As these other studies do not unequivocally support the findings of Hocking et al., we are left with two further lines of enquiry. One is to ask whether there are other explanations for the leukaemia excesses in northern Sydney, and the second is to question what is known of the physical properties of this type of non-ionising irradiation and whether there are any abnormal biological effects consequent on exposure of human tissue. There is not a great deal known of the possible harmful biological effects of radiofrequency non-ionising irradiations and nothing which might suggest that they cause malignant diseases. 5 A great deal more is known of the lower energy electromagnetic fields (50-60 Hz), but here, broadly speaking, no studies have yet suggested a likely biological link with a leukaemogenic process. This unsatisfactory state of affairs fuels public and clinical concerns and has led to a small epidemic of studies on childhood leukaemias aimed at investigating (using case-control methods) all known and hypothesised causes of the condition. These studies, in New Zealand, Canada, the United States, the United Kingdom and Germany, are all coming to fruition over the next few years. Not only do they represent the concern of the public, but also the general lack of knowledge of common risk factors for childhood leukaemias. Thus, other possible explanations for the observation of Hocking et al. are limited at the moment. Nevertheless, a good deal of descriptive epidemiology of childhood leukaemias is available, mainly from the United Kingdom. 6 This throws up some remarkable features of the diseases. Leukaemia is not evenly distributed among the childhood population -- it is roughly twice as common in areas that are either geographically isolated from major conurbations or of greater affluence. 7 Furthermore, childhood leukaemias do occasionally form close case aggregations or clusters. 8 Rare diseases will form striking clusters by chance, but in the case of childhood acute lymphoblastic leukaemia more occur than simply by chance. Where and why is not known, but is under investigation. 9 Is this association in Sydney the product of one of these quirks of distribution? Is there a local case excess in an affluent area, or even an unrecognised cluster of leukaemia? The way forward would certainly include a closer look at the Sydney data for evidence of these phenomena. Area cluster statistics should be used, 10 as well as a more rigorous application of point-source statistics, which, for example, look for decline in rates by distance for a putative point hazard. 11 These possible local studies, together with epidemiological studies from elsewhere, might show similar, and thus supporting, results. There is also the possibility of new biological studies supporting a causal link. However, a more complete knowledge of the causes of childhood leukaemia is essential in order to go down the road from association to causation. In that regard we have taken only the first few steps of a very long journey. Ray A Cartwright Professor of Cancer Epidemiology Leukaemia Research Fund, University of Leeds, Leeds, UK Maskarinec G, Cooper J, Swygert L. Investigation of increased incidence in childhood leukaemia near radio towers in Hawaii: preliminary observations. J Environ Pathol Toxicol Oncol 1994; 13: 33-37. Dolk H, Elliott P, Shaddick G, et al. Leukaemia incidence near high power radiotransmitters [abstract]. Epidemiology 1996; 7(Suppl 4): S95. Doll R. The epidemiology of childhood leukaemia. J R Statist Soc Ser A 1989; 152: 341-351. McKinney PA, Alexander FE, Roberts BE, et al. Yorkshire case-control study of leukaemias and lymphomas parallel multivariate analyses of seven disease categories. Leuk Lymphoma 1990; 2: 67-80. National Radiological Protection Board. Electromagnetic fields and the risk of cancer. Report of an Advisory Group on Non-Ionising Radiation. Vol 3, No. l. Chilton, Didcot, Oxfordshire: National Radiological Protection Board, 1992. Draper G, editor. The geographical epidemiology of childhood leukaemia and non-Hodgkin's lymphoma in Great Britain 1966-1983. London: HMSO, 1990. Alexander FE, Ricketts TJ, McKinney PA, Cartwright RA. Community lifestyle characteristics and risk of acute lymphoblastic leukaemia in children. Lancet 1990; 336: 1461-1465. Cartwright RA, Alexander FF, McKinney PA, Ricketts TJ. Leukaemia and lymphoma: an atlas of distribution within areas of England and Wales 1984-1988. London: Leukaemia Research Fund, 1990. Alexander FE, Wray N, Boyle P, et al. Clustering of childhood leukemia: a European study in progress. J Epidemiol Biostat 1996; 1: 13-24. Chen R, Mantel N, Kingberg M. A study of three techniquest of time-space clusters in Hodgkin's disease. Stat Med 1984; 3: 173-184. Bithell JF, Stone RA. On statistical methods for analysing the geographical distribution of cancer cases near nuclear installations. J Epidemiol Commun Health 1989; 43: 79-85. - To top of article - ©MJA 1996 <URL: http://www.mja.com.au/> © 1996 Medical Journal of Australia.

Ray A Cartwright

Cancer incidence and mortality and proximity to TV towers Bruce Hocking, Ian R Gordon, Heather L Grain and Gifford E Hatfield MJA 1996; 165: 601 For editorial comment, see Cartwright Readers may print a single copy for personal use. No further reproduction or distribution of the articles in whole or in part should proceed without the permission of the publisher. For copyright permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". Abstract - Introduction - Methods - Results - Discussion - Conclusion - References - Authors' details - ©MJA1996 Abstract Objective: To determine whether there is an increased cancer incidence and mortality in populations exposed to radiofrequency radiations from TV towers. Design: An ecological study comparing cancer incidence and mortality, 1972-1990, in nine municipalities, three of which surround the TV towers and six of which are further away from the towers. (TV radiofrequency radiation decreases with the square of the distance from the source.) Cancer incidence and mortality data were obtained from the then Commonwealth Department of Human Services and Health. Data on frequency, power, and period of broadcasting for the three TV towers were obtained from the Commonwealth Department of Communications and the Arts. The calculated power density of the radiofrequency radiation in the exposed area ranged from 8.0 µW/cm 2 near the towers to 0.2 µW/cm 2 at a radius of 4 km and 0.02 µW/cm 2 at 12 km. Setting: Northern Sydney, where three TV towers have been broadcasting since 1956. Outcome measures: Rate ratios for leukaemia and brain tumour incidence and mortality, comparing the inner with the outer areas. Results: For all ages, the rate ratio for total leukaemia incidence was 1.24 (95% confidence interval [CI], 1.09-1.40). Among children, the rate ratio for leukaemia incidence was 1.58 (95% CI, 1.07-2.34) and for mortality it was 2.32 (95% CI, 1.35-4.01). The rate ratio for childhood lymphatic leukaemia (the most common type) was 1.55 (95% CI, 1.00-2.41) for incidence and 2.74 (95% CI, 1.42-5.27) for mortality. Brain cancer incidence and mortality were not increased. Conclusion: We found an association between increased childhood leukaemia incidence and mortality and proximity to TV towers. MJA 1996; 165: 601-605 Introduction The biological effects of low level electromagnetic fields and any relation to cancer causation are controversial. There have been several epidemiological studies of possible effects of extremely low frequency (50 Hz) fields, 1 but few have looked at radiofrequency radiations (RFR) (i.e., frequencies of 300 kHz to 300 GHz). Goldsmith, 2 in a recent review, concluded that there may be an association between RFRs and cancer; however, a World Health Organization review concluded that there is no clear evidence of detrimental health effects in humans exposed to RFR. 3 An opportunity for studying the effect of RFR presents itself in northern Sydney, New South Wales, where three TV towers are sited in a triangle close to each other (Figure 1). The towers have been used to broadcast three TV services since 1956 and four since 1965. The channel frequencies range from 63 to 215 MHz; the wavelengths (ranging from 5 m to 1 m) are close to body reson ances and hence are maximally absorbed. 3 We compared cancer incidence and cancer mortality for the three municipalities (Lane Cove, Willoughby and North Sydney -- population, 135 000) which immediately surround the TV towers (inner area) with data for six adjacent municipalities (Ryde, Ku-ring-gai, Warringah, Manly, Mosman and Hunters Hill -- population, 450 000) (outer area) (Figure 1), on the basis that the RFR becomes progressively weaker with the square of the distance from the towers across these municipalities. The control municipalities were selected because of the similar distance from the towers to their nearest borders, their resi dents having a similar upper-middleclass socioeconomic status, 4 and their areas being large enough for there to be a decrease in power density. Cancers of interest were leukaemia and brain tumour, especially in childhood, given findings from community studies of extremely low frequency (50 Hz) electro magnetic fields. 1 We had no prior knowledge of, nor had concerns been raised about, clusters of leukaemia cases in the areas close to the towers. Methods Radiofrequency radiation Data for frequency and power of the RFR sources on the towers for the period 1956-1990 were obtained from the Commonwealth Department of Communications and the Arts 5 and are shown in Box 1.1. The TV signals are composed of 100 kW video amplitude modulated (AM) and 10 kW audio frequency modulated (FM) signals, on carrier frequencies which range from 63 to 215 MHz. The combined field strengths at increasing distances were calculated by the method of the United States National Council on Radiation Protection and Measurement 6 (Box 1). There were no TV repeater stations in the inner or outer areas during the survey period. Cancer data The NSW Cancer Registry maintains a comprehensive database allowing distinction between incidence and mortality, and giving residence at the time of report. 4 Data from the registry for 1972 to 1990 are available from HealthWiz 7 and were extracted by municipality, and for sex and age bands 0-14 years, 15-69 years and 70 years and over. The data are available only for the three-digit code categories identified by the International classification of diseases, injuries and causes of death , ninth revision (ICD-9). More refined data are not available for reasons of privacy. Cancer data from before 1972 are not available. Statistical analysis The data were analysed using a Poisson regression model, 8 in which the number of cases or deaths were regarded as Poisson random variables, whose mean is a product of the person-years (i.e., the sum of appropriate mid-year populations) pertaining to the observation and the functions of the explanatory variables. These models give rate ratio estimates for comparisons of interest, adjusted for the other variables. Interactions were examined, and the model tested for goodness-of-fit. We made adjustment for extra-Poisson variation, when necessary, using the "quasi-likelihood" method of McCullagh and Nelder. 9 The explanatory variables fitted in these models were: age in years (0-14, 15-69, 70 and over), sex, calendar period (1972-1978, 1979-1984 and 1985-1990), and area ("inner" [close to the TV towers] and "outer" [more distant]) (Figure 1). For comparisons between the areas of interest and the whole of New South Wales, standardised incidence ratios (SIRs) and standardised mortality ratios (SMRs) were calculated. For these analyses the stratification was by calendar-year (19 separate years), age and sex. Confidence intervals were calculated by the "exact" method. 10 Results Box 2 shows the data structure used in the analysis; the leukaemia cases and person-years in each cell were obtained by summing across the years for that age-group and sex combination. The rate ratios comparing the inner with the outer areas are shown in Boxes 3 and 4. No increase in brain cancer incidence or mortality was found, but there was an increased leukaemia incidence and mortality in the municipalities close to the towers. The rate ratio for childhood leukaemia incidence (Box 4) was 1.58 (95% CI, 1.07-2.34) and for mortality was 2.32 (95% CI, 1.35-4.01). These rates were broadly consistent across the types of leukaemia; for lymphatic leukaemia, the rate ratio was 1.55 for incidence and 2.74 for mortality. Our analysis pooled data from the inner and outer municipalities. To see whether results within each municipality were similar, we performed tests of homogeneity for childhood leukaemia incidence and mortality. No significant heterogeneity was found ( P = 0.10 for incidence and P = 0.13 for mortality). We found no significant overall trends across time for brain cancer or leukaemia incidence, for all ages combined or for children alone. For children, there was a significant overall reduction in leukaemia mortality over time ( P = 0.008), but no significant evidence of a change over time in the differences between the outer and inner areas in brain cancer or leukaemia incidence or mortality, for all ages combined or for children alone. Because a small part of Hunters Hill projects close to the TV towers (Figure 1) and there is a potential confounder there (a factory which used radium until the 1970s in Hunters Hill), the data were analysed excluding Hunters Hill. The incidence rate ratio for childhood leukaemia was 1.56 (95% CI, 1.09-2.22), and for all ages was 1.23 (95% CI, 1.06-1.43). Childhood cancer incidence and mortality (brain cancer and leukaemia) for the inner and outer areas were compared with cancer incidence and mortality data for the whole of New South Wales (Box 5). There was no difference for cancer of the brain. Leukaemia incidence and mortality were significantly increased in the inner area, but incidence and mortality data for the outer area were similar to data for the State as a whole. Discussion This ecological study found an association between residential proximity to TV towers and increased incidence of childhood leukaemia. Study biases Studies of this type are prone to biases. 1. Comparison of the inner and outer areas: Socioeconomic class has been associated with leukaemia, with a positive association with higher socio economic status. However, all muni cipalities considered in the inner and outer areas are ranked in the top two socioeconomic quintiles; further, two out of three of the inner municipalities are in the top quintile, and four out of six of the outer municipalities are in the top quintile. 4 Moreover, for New South Wales as a whole there is no evidence of a socioeconomic gradient for leukaemia. 4 There are small pockets of light industry in the surveyed municipalities, but they are mainly residential. The area closer to the TV towers is subject to much higher traffic density than the outer area, and exhaust fumes contain small traces of benzene, a proven leukaemogen. 11 However, a causal relationship between exhaust fumes and childhood leukaemia has not been established; 11 in occupational studies benzene exposure is related predominantly to acute myeloid leukaemia, 12 but we found an increased incidence/mortality of lymph atic leukaemia in the inner areas. 2. Confounding variables affecting individuals can not be adjusted for. The few recognised causes of leukaemia include ionising radiation, cytotoxic drugs and some uncommon genetic conditions. 13 The only known potential community exposure to ionising radiation in the study area is a factory in Hunters Hill that used radium until the 1970s. There are no high voltage power lines traversing the inner area, but one traverses the outer area and runs along the border between Lane Cove and Ryde in a national park. Individual (household) exposure cannot be determined, and therefore local enhancements and attenuations of RFR , which might influence dose-response calculations, cannot be allowed for. Usually, exposures in flats and houses will be lower than those for free space, such as gardens, parks and schoolyards. 3. Population movement cannot be adjusted for. Thus, miscalculations arise if people move out of, or into, particular areas for selective reasons (e.g., treatment of cancer is offered at Royal North Shore Hospital, which is in the inner area). This would not influence incidence, but could influence mortality data if patients with cancer came to live closer to the hospital for ease of access. However, it appears most childhood leukaemia cases attend children's hospitals not in the study area. A linkage study of cases could resolve this. On the other hand, social mobility would tend to obscure effects that have long latency periods. Duration of residence would need to be determined in a more detailed study. Migration to new towns has been suggested as a confounding factor in childhood leukaemia clusters, 14 with viral spread to susceptible persons, but the areas surveyed in this study are long established. Greaves, 15 using a similar argument, postulated that fewer infectious stimuli in early postnatal life, with later infection at a critical period, may play a major role in precipitating acute lymphoblastic leukaemia. According to this theory, less dense populations mean less exposure to infections early in life and higher rates of leukaemia. However, of the areas surveyed the inner area is the more densely populated (2818 per km 2 , compared with 1378 per km 2 ). 16 Effects of radiofrequency radiation The calculated exposure levels of 8.0 to 0.2 µW/cm 2 in the inner area are very low compared with the Australian Standard 17 public exposure level of 0.2 mW/cm 2 . The mechanism whereby such low energies could cause biological effects is a matter of intense research. A recent report by the Commonwealth Scientific and Industrial Research Organisation (CSIRO) concluded that reliance on thresholds for heat build-up in setting the Australian safety standard may be insufficient. 18 The TV frequencies considered, because of their wavelengths in relation to body heights, are close to body resonance, 3 leading to maximum absorption by both adults (including pregnant women 19 ) and children. However, in considering any biological effects, regard must be given to the modulations (50 Hz to 5 MHz) as much as to the carrier wave. The key video modulation frequencies are pulsed at 50 Hz and 15.6 kHz. Many and conflicting reports have been published about possible biological effects at low energy levels with low frequency amplitude modulations. 3,18,20,21 Stuchly et al. found that 60 Hz low-level fields may act as promoters of cancer. 22 It has been suggested that the biological effects may be on the cell membrane rather than the genetic material, 23 and that low energy signals are detected through non-linear mechanisms, such as stochastic resonance. 24 The disparity between our calculations and the measured power densities could result from various mechanisms, including absorption of the signal and cancellation due to reflections, especially as the minimum of one signal is unlikely to coincide with the minimum of another, even being different for the audio and vision signals of one channel. An extensive measurement program is needed to develop detailed contour maps to better define dose-response relationships. Techniques such as isotonic regression could be used; this enables effects of a point source on a surrounding community to be analysed. 25 The new services since 1980 will have increased the power density due to Tower 1 by four times, most of this being due to ultra high frequency (UHF) TV (526-533 MHz) and FM radio. A number of other services, such as mobile phone and paging services, may have also been established in the surveyed areas. However, these are of much lower power and/or use different carrier frequencies and/or modulations to the TV broadcast services. Radiofrequency radiation and cancer? An association between RFR and childhood leukaemia has not been reported previously. None of the previous studies of RFR has looked at exposure of such a large population (including children) for so long a time to frequencies of maximal body absorption. A study of people working on TV towers did not find evidence of chromosome damage, 26 and among 32 cases of neoplasms of the blood in Telecom Australia employees (retiring for medical reasons or dying) there was no excess in radiocommunication occupations (Hocking, unpublished data). A small study from Honolulu (Hawaii), where broadcast towers are also situated in populated areas, compared census tracts with towers with those without towers and found a non-significant standarised incidence ratio of 1.5 for all types of leukaemia. 27 A preliminary report of a small area study of leukaemia near 20 TV/FM transmission sites in the United Kingdom found a decline in incidence of adult leukaemia with distance, but concluded that "the results give, at most, no more than weak support for an association between residence near transmitters and leukaemia risk". 28 However, that study was restricted to adult leukaemia and incidence, whereas our most significant results were for childhood leukaemia incidence and mortality. The time trend for childhood leukaemia incidence has remained fairly stable, consistent with a constant exposure, and the reduction noted in the childhood leukaemia mortality rate most likely reflects improvements in treatment. If RFR exposure is a relevant (causal) factor, classification of population into inner and outer areas is a proxy for the appropriate exposure variable, which would tend to bias the rate ratios towards the null (i.e., towards no effect) due to non-differential misclassification. This is relevant to the irregular natural boundaries of the municipalities (Figure 1). Analysis by postcode or census collector units would yield more refined data in relation to distance from the towers. Finally, our observation of a more marked association between proximity to TV towers and leukaemia mortality than incidence (Box 4) could be of biological interest if a putative exposure not merely caused the disease but influenced its progression. Conclusion The calculated levels of RFR in the areas with increased childhood leukaemia incidence and mortality are substantially below the current Australian public safety standard. More detailed studies (e.g., relating cases to power density contours) are required to replicate any association and to look for dose-response relationships before any conclusions can be drawn. References Savitz D, Ahlbom A. Epidemiologic evidence of cancer in relation to residential and occupational exposures. In: Carpenter D, Ayrapetyan S, editors. Biological effects of electric and magnetic fields. Chapter II. Vol 2. Sydney: Academic Press, 1994: 233-261. Goldsmith JR. Epidemiologic evidence of radio-frequency (microwave) effects on health in military broadcasting and occupational studies. Int J Occup Med Environ Health 1995; 1: 47-57. World Health Organization. Environmental Health Criteria 137 Electromagnetic fields (300 Hz to 300 GHz). WHO: Geneva, 1993: 164-168, 74-75. Smith D, Taylor R, Coates M. Socioeconomic differentials in cancer incidence and mortality in urban New South Wales 1987-1991. Aust N Z J Public Health 1996; 20: 129-137. Department of Communications and the Arts. Radio and Television Broadcasting Stations. Canberra: AGPS, 1994. National Council on Radiation Protection and Measurement. A practical guide to the determination of human exposure to radiofrequency fields. Bethesda, Md: NCRP, 1993. (NCRP Report No. 119.) HealthWiz. National health database. Commonwealth Department of Human Services and Health. 1991-1996. Canberra: Prometheus Pty Ltd, 1996. Frome EL. The analysis of rates using Poisson regression models. Biometrics 1983; 39: 665-674. McCullagh P, Nelder JA. Generalized linear models. London: Chapman and Hall, 1983: 80-81. Liddell J. Simple exact analysis of the standardised mortality ratio. J Epidemiol Community Health 1984; 38: 85-88. UK Department of the Environment. Expert Panel on Air Quality Standards. Benzene. London: HMSO, 1994. Akasoy M. Benzene carcinogenicity. Boca Raton, Fl: CRC Press, 1988: 119-125. Doll R, Darby S. Childhood leukaemia in the United Kingdom. Radiat Protect Aust 1990; 8(3): 55-61. Childhood leukaemia: an infectious disease? [editorial]. Lancet 1990; 336: 1477-1479. Greaves MF. Etiology of childhood acute lymphoblastic leukemia: a soluble problem? In: Gale RP, Hoelzer D, editors. Acute lymphoblastic leukemia. UCLA Symposium on Molecular and Cellular Biology. New Series Vol 108. New York: Academic Press, 1989. Digital Cadastral Database. Bathurst, NSW: Land Information Centre. Australian Standard AS2772.1. Radiofrequency Radiation Part 1: Maximum Exposure Levels -- 100 kHz to 300 GHz. Sydney: Standards Australia, 1990. Barnett S. Status of research on biological effects and safety of electromagnetic radiation: telecommunications frequencies. Chatswood: Division of Radiophysics CSIRO, 1994. Fleming AHJ, Joyner KH. Estimates of the absorption of radiofrequency radiation by the embryo and foetus during pregnancy. Health Phys 1992; 63: 149-159. Adey R. Effects of weak amplitude modulated microwave fields on calcium efflux from awake cat cerebral cortex. Bioelectromagnetics 1982; 3: 295-307. Adey R. Frequency and power windowing. Proc IEEE (Proceedings of the Institution of Electrical and Electronic Engineers) 1980; 68 (1): 119-125. Stuchly MA, McLean J, Burnett R, et al. Modification of promotion in the mouse skin by exposure to an alternating magnetic field. Cancer Lett 1992; 65: 1-7. Weaver J, Astumian RD. The thermal noise limit for threshold effects of electric and magnetic fields in biological systems. In: Carpenter D, Ayrapetyan S, editors. Biological effects of electric and magnetic fields. Chapter 3, Vol 1. Sydney: Academic Press, 1994: 83-104. Moss F, Wiesenfield K. The benefits of background noise. Sci Am 1995; August: 50-54. Stone RA. Investigations of excess environmental risk around a putative source. Statistical problems and a proposed test. Stat Med 1988; 7: 649-660. Garson MO, McRobert TL, Campbell LJ, et al. A chromosomal study of workers with long-term exposure to RFR. Med J Aust 1991; 155: 289-292. Maskarinec G, Cooper J, Swygert L, et al. Investigation of increased incidence in childhood leukaemia near radio towers in Hawaii: preliminary observations. J Environ Pathol Toxicol Oncol 1994; 13: 33-37. Dolk H, Elliott P, Shaddick P, et al. Leukaemia incidence near high power radio transmitters [abstract]. Epidemiology 1996; 7(Suppl 4): S95.(Received 3 Oct 1995, accepted 25 Sep 1996) Authors' details Bruce Hocking and Associates, 9 Tyrone Street, Melbourne, VIC. Bruce Hocking , FAFOM, FAFPHM, Consultant in Occupational Medicine. Statistical Consulting Centre, University of Melbourne, Melbourne, VIC. Ian R Gordon , PhD, Director. System Innovations in Health, PO Box 125, Melbourne, VIC. Heather L Grain , ADipMRA, GDipDP, Consultant. Broadcast & Radiation Safety Consulting, Melbourne, VIC. Gifford E Hatfield , MSEE, Managing Director. No reprints will be available. Correspondence: Dr B Hocking, 9 Tyrone Street, Camberwell, VIC 3124. To top of article - ©MJA 1996 <URL: http://www.mja.com.au/> © 1996 Medical Journal of Australia.

Bruce Hocking · Ian R Gordon · Heather L Grain · Gifford E Hatfield

Alternative cancer treatments We must let patients know we are on their side and make every effort to ascertain and deliver what it is they seek from treatment MJA 1996; 165: 536 Readers may print a single copy for personal use. No further reproduction or distribution of the articles in whole or in part should proceed without the permission of the publisher. For copyright permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". - - ©MJA1996 In this issue of the Journal, Begbie and colleagues show once again the continued attraction of alternative medicine or unproved remedies. In many developed countries, a large proportion of the general public (nearly half over 12 months, according to a recent survey in South Australia 1 ) attend alternative practitioners, use unconventional therapies, or both. It seems not to matter whether the country has a universal health scheme or not; the public is prepared to spend large sums on alternative treatment, as shown in studies from both the United States 2 and the United Kingdom. 3 Several of the surveys have shown that among users of alternative practitioners and alternative remedies there is a bias towards younger, fitter people, towards women and towards the better educated. However, it is not just the healthy who turn to alternatives. As the paper by Begbie and colleagues, and others, 4 shows, among cancer patients the use of alternative therapy is widespread. Why is this so and what can the medical profession learn from this? Some of the attractions of alternative treatments for cancer are perhaps self-evident. When faced with an illness incurable by medical science, patients and their families understandably turn to those who claim that their remedies are effective, "natural" and harmless. Thus, alternative therapies abound not only for cancer but also for conditions such as multiple sclerosis and rheumatoid arthritis. These therapies do, however, come and go. Where now is copper ointment for rheumatoid arthritis? Where now is ozone treatment for HIV? For cancer, where now Krebiozen (a treatment popular in the 1950s), Milan Brych's secret remedy (of the 1970s) and Laetrile (from the 1980s)? Although these have gone, others have replaced them. In Australia, the most popular currently are diets, and psychological measures such as relaxation and meditation. As quoted by Begbie et al., there are "no unproven treatments for universally curable diseases". 5 It might also be relevant that there are few unproven treatments for conditions that can be more readily understood than cancer, such as pneumonia, bone fractures and venous thrombosis. When medical science has an effective treatment, even if it's not a cure, the alternative industry has little to offer. An important message is that the profession should use its available treatments to best advantage. The current trend to "evidence-based medicine" will strengthen our hand, and guide doctors to the most effective treatments. For example, the publications on early breast cancer distributed by the National Breast Cancer Centre 6,7 should provide an effective answer to many patients' questions and may limit their need to seek help from the un qualified. Patients may not necessarily seek a "cure" -- effective symptom relief, using modern palliative care, may fulfil the needs of many. It is also important for medical practitioners to gain patients' confidence so that they do not feel inhibited about discussing alternative treatments. The discussion may reveal that the patient feels pressured into trying some alleged cure by a well-meaning, but ill-informed, friend or relative. Straightforward scientific information about the lack of evidence of the "remedy" in question may be all that the patient is seeking. If the doctor is unfamiliar with the particular treatment, a Cancer Council will provide the information needed. The discussion may reveal that what patients really seek is something that may be as readily available through orthodox channels as the unorthodox. All of the State and Territory Cancer Councils run their own support and self-help groups, or can refer patients to those organised by approved organisations and institutions. Meditation, social support and a sympathetic ear can also be found, if not through the Cancer Councils, then the oncology department of the local hospital should be able to point patients in the appropriate direction. Should we be concerned? That so many patients seek "alternatives" not only indicates certain failings in the services provided by the profession, it actually exposes patients to potential harm. 8-10 Many so-called cancer diets are nutritionally inadequate, the costs may be substantial and "natural" does not necessarily equate to "harmless". Some natural substances that are far from harmless include snake venom, strychnine, toadstools, potato leaves and tobacco. Laetrile and comfrey, previously recommended for the treatment of cancer, carry their own dangers. Some allegedly natural herbal medications conceal their real ingredients. 11 There is also the danger that patients may forgo proven effective treatments for cancer, and their only chance of cure. None of this discussion denies the many shortcomings of orthodox medicine nor the potential dangers of our own prescriptions. Nor does it lessen the need for the scientific study of folk remedies in the hope of finding new effective "natural" treatments to follow, for example, aspirin (from willow bark) or paclitaxel (from the Pacific yew tree). It is important for the public to know that we are on their side. With treatments for cancer, cure is the aim whenever possible, but always and above all else the aims are comfort and relief of suffering. The medical profession must ensure that a wide range of treatments and support services is available to cancer patients. Their needs can best be met by a doctor-patient partnership, by free discussion, and by use of measures of proven effectiveness. Raymond M Lowenthal Director of Medical Oncology, Royal Hobart Hospital, TAS MacLennan AH, Wilson DH, Taylor AW. Prevalence and cost of alternative medicine in Australia. Lancet 1996; 347: 569-573. Lerner IJ, Kennedy BJ. The prevalence of questionable methods of cancer treatments in the United States. CA Cancer J Clin 1992; 42: 181-191. Downer SM, Cody MM, McClusky P, el al. Pursuit and practice of complementary therapies by cancer patients receiving conventional treatment. BMJ 1994; 309: 86-89. Sawyer MG, Ganom AF, Toogood IR, et al. The use of alternative therapies by children with cancer. Med J Aust 1994; 160: 320-322. Cassileth BR. The social implications of questionable cancer treatments. CA Cancer J Clin 1989; 39: 311-316. Clinical practice guidelines. The management of early breast cancer. Canberra: National Health and Medical Research Council, 1995. A consumer's guide. Early breast cancer. Canberra: National Health and Medical Research Council, 1995. Lowenthal RM. On eye of newt and bone of shark. The dangers of promoting alternative cancer treatments. Med J Aust 1994; 160: 323-324. Lowenthal RM. Can cancer be cured by meditation and "natural therapy"? A critical review of the book You can conquer cancer by Ian Gawler. Med J Aust 1989; 151: 710-715. Abbot NC, White AR, Ernst E. Complementary medicine. Nature 1996; 381: 361. Bayly GR, Braithwaite RA, Sheehan TMT, et al. Lead poisoning from traditional remedies in the West Midlands -- report of a series of five cases. Human Exp Toxicol 1995; 14: 24-28. - - To top of article - ©MJA 1996 <URL: http://www.mja.com.au/> © 1996 Medical Journal of Australia.

Raymond M Lowenthal

Patterns of alternative medicine use by cancer patients Stephen D Begbie, Zoltan L Kerestes and David R Bell MJA 1996; 165: 540 For editorial comment, see Lowenthal Readers may print a single copy for personal use. No further reproduction or distribution of the articles in whole or in part should proceed without the permission of the publisher. For copyright permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia <http://www.mja.com.au/>". Abstract - Introduction - Methods - Results - Experiences of conventional treatment - Alternative treatment - Patient characteristics and alternative therapy use - Discussion - Acknowledgements - References - Authors' details - - ©MJA1996 Abstract Objective: To assess the patterns of alternative medicine use in patients of a public hospital oncology unit, and to compare patients' experience of alternative with conventional medicine. Design and setting: Self-administered questionnaire survey of cancer patients attending specialist consulting rooms at the Royal North Shore Hospital and the Oncology Outpatient Clinic at Port Macquarie Base Hospital during August 1995. Participants: 507 patients attended the clinics; 335 (66%) returned questionnaires, of which 319 (62%) were sufficiently complete for analysis. Main outcome measures: Expectations of and satisfaction with both conventional and alternative treatment, use of alternative treatment, and patient characteristics associated with this use. Results: Expectations of and satisfaction with both conventional and alternative treatment were very high. Alternative treatments (most commonly dietary and psychological methods) were used by 21.9% of patients. Median annual cost of alternative therapy was $530, with most patients reporting "value for money". Younger age and being married were positively associated, and satisfaction with conventional treatment was negatively associated, with alternative medicine use; 40% of patients did not discuss alternative medicine with their physician. Conclusions: A significant proportion of cancer patients use one or more forms of alternative therapy. The use of alternative therapy may reflect on deficiencies in the current standard of care. MJA 1996; 165: 545-548 Introduction Rapid developments in the conventional management of cancer have been accompanied by an increased consumer-driven move toward choice and individual control. While alternative (or complementary) medicine has always existed, its availability and variety are growing and its use increasing. 1 Cancer patients use alternative therapies despite arguments such as lack of scientific validity, proven ineffectiveness of some treatments and reliance on the placebo effect. It may be helpful for Australian doctors to know the range of alternative therapies used by cancer patients, and to have an understanding of the reasons why they use such therapies, as this may cast some light on deficiencies in the current standard of conventional care. We aimed to investigate the range of alternative therapies used by cancer patients attending outpatient clinics conducted by a teaching hospital clinical oncology unit, and to assess the level of satisfaction with these therapies and with conventional therapy. Methods Our subjects were all patients who attended the specialist consulting rooms of three medical oncologists at Royal North Shore Hospital (RNSH) in Sydney, and the Oncology Outpatient Clinic at Port Macquarie Base Hospital (PMBH), New South Wales, during August 1995. Reception staff offered each patient a self-administered questionnaire, with a covering letter from the chief investigator encouraging participation, and assuring confidentiality. Response to the questionnaire was voluntary, and patients were not asked to give explanations for not responding. The questionnaire sought demographic data, and the following information about their conventional treatment: understanding of diagnosis and treatment, expectations before treatment, impressions at the conclusion of treatment, and overall satisfaction. All questions were multiple choice, with the exception of diagnosis. Those who had used alternative medicine were asked (in multiple-choice questions, but with space for comments) to outline their reasons for doing so, as well as the treatments chosen. The questionnaire did not seek details of the chosen therapies. The same questions that were used to assess their conventional medicine experience were used to assess their alternative medicine experiences. In addition, they were asked about the reaction of family and friends to their use of alternative therapy, whether they had discussed alternative treatment with their medical oncologist, to estimate the financial cost, and whether they felt they had received value for money. Data were analysed using the Statistical Package for the Social Sciences 2 to determine associations between patient characteristics and alternative medicine use; significance was measured by the odds ratio. Logistic regression analysis was used to analyse all variables which may affect use of alternative therapy. Approval for this study was received from the Royal North Shore Hospital Ethics Committee, and from Port Macquarie Base Hospital. Results Five hundred and seven patients attended, of whom 335 (66%) responded (271 from RNSH, 64 from PMBH). Sixteen questionnaires were excluded from assessment (the alternative medicine question was unanswered in 12, no demographic details were given in 3, and one was returned blank), leaving 319 (62%) to be assessed. Demographic details for the 319 patients are shown in Box 1. It is noteworthy that in our study women, married people, and those with high levels of education and private health insurance predominate. Only 22.9% of the 319 patients were in paid employment, and median household income was in the $20 000-$40 000 range. A wide variety of diagnoses were represented; breast cancer was the single most common diagnosis. Experiences of conventional treatment Most respondents had received chemotherapy, and many had undergone other kinds of cancer therapy (Box 1). When asked about their expectations at the beginning of treatment, 85.6% believed that it would cure them or prolong their lives. By contrast, at the end of conventional treatment 63.0% felt that they had been cured or that their life had been prolonged, while 8.2% felt that their treatment had been of no benefit, or had made them worse. Most respondents (75.3%) were either satisfied or very satisfied with their experience of conventional therapy, while only 3.1% were either unsatisfied or very unsatisfied. Alternative treatment Seventy patients of the 319 assessed (21.9%) indicated that they were using alternative therapy. The most frequently given reasons were a preference for natural therapy, and seeing the alternative therapy as another source of hope (Box 2). Box 3 shows the alternative therapies chosen; dietary and psychological methods were most prevalent, followed by herbalism. Seventy-five per cent of patients tried more than one therapy (median, 3; range, 1-8). Most of the patients had learnt of alternative therapies through friend or family recommendation (37; 52.9%), and personal research (32; 45.7%), while doctor's recommendation (11; 15.7%) and media reports (6; 8.6%) were less common (some patients cited more than one source). In addition, family and friends were overwhelmingly supportive, with those of 64 patients (91.4%) being either encouraging or tolerant of the use of alternative therapies. At the beginning of alternative treatment 51 patients (72.9%) expected it would cure them or prolong their lives, while at the completion 34 (48.6%) felt that they had been cured, or that their lives had been prolonged. Only seven (10%) had the impression that alternative treatment was of no benefit, or had made them worse. Overall, 49 patients (70%) were satisfied or very satisfied with alternative treatment, and only one (1.4%) was unsatisfied. Forty-five patients gave an estimate of the annual cost of their alternative therapy; the median annual cost was $530 (range, 0-$20 000). Of the 70 patients who had alternative therapy, 45 (64.3%) felt they were getting value for money, five (7.1%) did not, and the remainder did not answer this question. Importantly, 37 (52.9%) felt that they could discuss their alternative treatment with their physician, while 28 (40%) felt they could not. Patient characteristics and alternative therapy use Being young and being married were significantly associated with use of alternative medicine, with marital status significant at P = 0.02. Logistic regression analysis showed that age and satisfaction with conventional therapy are the key predictors for a decision to use alternative therapy. Overall, younger patients used more alternative therapy (odds ratio, 1.67; P < 0.0001; 95% CI, 1.32-2.13), and those who were very satisfied with their conventional treatment used less alternative therapy (odds ratio, 0.55; P < 0.0001; 95% CI, 0.38-0.79). Sex, level of education, employment status, income, private health insurance, diagnosis, expectations at beginning of treatment or impressions at the end of treatment were not significantly associated with use of alternative therapy. Discussion Any discussion of alternative medicine is complicated by arguments about terminology. The most commonly used terms in the literature are "alternative", "complementary" or "unproven". Some have suggested that the term "alternative" is spurious, because it suggests equally valid options, 3 but we have chosen to use it because it is in common use in describing treatments outside conventional medicine. "Complementary" may seem an appropriate term for a study of patients attending a hospital, but it suggests therapies that are valuable when combined with conventional medicine. "Unproven" is the American Cancer Society's preferred term and relates to methods that are "on the basis of careful review by scientists and/or clinicians, not deemed proven, nor recommended for current use". 4 It has also been suggested that "There are no unproven treatments for universally curable diseases" 5 -- the very fact that this issue is so controversial in cancer medicine suggests that conventional treatment has a long way to go in optimising management of malignant disease. Previous studies have shown that between 9% and 54% of adult cancer patients use some form of alternative medicine, 6-10 while a recent Australian study reported a 46% rate of alternative therapy use in a paediatric oncology population. 11 The rate of alternative medicine use in our study (21.9%) is within this range. It may not be an accurate reflection of alternative therapy use in cancer patients as our patients' response to the questionnaire was voluntary, creating a potential selection bias. Nevertheless it does indicate that a significant proportion of cancer patients use some form of alternative therapy, and gives some idea of the current range of therapies. Several features of our study population should be considered when relating our results to other populations. Royal North Shore Hospital services the northern Sydney area, where the population is characterised by being relatively wealthy, and having high levels of education and private health insurance. Port Macquarie Base Hospital serves a community with a large retired population and relative wealth (by rural standards). The high prevalence of breast cancer managed by this unit explains the predominance of women in the group studied. There was a high level of optimism at the outset of both conventional treatment and alternative therapy (85.6% v. 63.0% belief in cure/life-prolongation), which fell modestly by completion of treatment (72.9% v. 48.6%). As most patients were receiving palliative chemotherapy, it seems that many patients had an unrealistic expectation about the goals of treatment. This reinforces the need for clear communication with patients. However, most patients were highly satisfied with both conventional and alternative treatments (75.3% v. 70.0%), and dissatisfaction was almost non-existent (3.1% v. 1.4%). This high level of satisfaction, often in the absence of objective benefit, has been described in studies of conventional 12 and alternative 6,11 medicine, and may be related to a hope engendered by the intervention of a clinician. 13,14 As in other studies which report that patients will frequently try multiple alternative therapies, 6,11 we found that over 75% of patients used two or more therapies. Alternative therapies available in Australia appear to be a mixture of the British and United States experience. Psychological methods such as relaxation, imagery and healing, which are prevalent in the United Kingdom, 6 and interventional methods, such as diet and megavitamins, more common in the US, 7 are used with similar frequency. The predominance of friend and family recommendation (52.9%) as the source of information on alternative medicine may partially explain the significantly increased use by married patients. The contribution of recommendation by doctors is comparatively low, but it must be remembered that these patients were attending an oncology service. Of course, some cancer patients may not seek conventional care, and consultations with alternative practitioners, or with medical practitioners who combine conventional and alternative therapies, are becoming more common. 15,16 In the US there are currently more referrals to alternative practitioners than to primary care physicians. 17 Many studies report the significant financial costs of alternative medicine. 5,9,18-20 There is a wide variation in the cost of various therapies, with psychological methods usually far less expensive than interventions such as metabolic therapy, Laetrile and high-dose vitamin C. In one US study, the median annual outlay was US$262, and the mean was US$3492, suggesting enormous expense in some cases. 7 Our findings are similar, with expenditure ranging from nothing to $20 000 per year. However, nearly all of those using alternative medicine felt they were getting value for money. Previous studies have reported that users of alternative therapy tend to be young, female, of higher social class and more highly educated, while income, increased time since cancer diagnosis, increased number of people in a household, and tumour site may be associated with alternative therapy use. 6,7,9 We found that being young and being married were significantly associated with increased use, and that those who were very satisfied with conventional therapy used less alternative therapy. The finding that being married is associated with increased use of alternative therapy may be related to having increased numbers in a household, 9 and perhaps greater access to ideas and support for trying new things. Many patients in our study did not discuss their use of alternative therapy with their physicians, possibly because they were afraid of getting a negative response. This may reflect a need to improve doctor-patient communication. If a proportion of patients are going to use alternative therapies, it is important that their doctors are informed: firstly, so that possible interactions and complications can be avoided, and, secondly, to enable doctors to provide informed opinion on the alternative choices available. Acknowledgements We thank Professor John A Levi and Dr Helen R Wheeler for contributing their patients to the study. References MacLennan AH, Wilson DH, Taylor AW. Prevalence and cost of alternative medicine in Australia. Lancet 1996; 347: 569-573. SPSS: Statistical package for the social sciences [computer program], version 5. Chicago, Ill: SPSS inc, 1990. McGinnis LS. Alternative therapies, 1990. An overview. Cancer 1991; 67: 1788-1792. Pamphlet number 3028-REV. Atlanta, Ga.: American Cancer Society, 1990. Cassileth BR. The social implications of questionable cancer therapies. CA Cancer J Clin 1989; 39: 311-316. Downer SM, Cody MM, McCluskey P, et al. Pursuit and practice of complementary therapies by cancer patients receiving conventional treatment. BMJ 1994; 309: 86-89. Cassileth BR, Lusk EJ, Strouse TB, Bodenheimer BA. Contemporary unorthodox treatments in cancer medicine. A study of patients, treatments and practitioners. Ann Intern Med 1984; 101: 105-112. Harris L and associates. Health information and the use of questionable treatments: a study of the American Public, 1987. Washington DC: Department of Health and Human Services, 1987. Lerner IJ, Kennedy BJ. The prevalence of questionable methods of cancer treatments in the United States. CA Cancer J Clin 1992; 42: 181-191. Miller MJ, Boyer MJ, Dunn SM, et al. Why do Australian cancer patients use unproven therapies? Proc Clin Oncol Soc Aust 1995; 22: 78. Sawyer MG, Gannom AF, Toogood IR, et al. The use of alternative therapies by children with cancer. Med J Aust 1994; 160: 320-322. Coates A, Gebski V, Bishop JF, et al. Improving the quality of life during chemotherapy for advanced breast cancer. N Engl J Med 1987; 317: 1490-1495. Stoll BA. Can unorthodox cancer therapy improve quality of life? Ann Oncol 1993; 4: 121-123. Kodish E, Post SG. Oncology and hope. J Clin Oncol 1995; 13: 1817-1822. Borkan J, Neher JO, Anson O, Smoker B. Referrals for Alternative therapies. J Fam Prac 1994; 39: 545-550. Paterson C, Peacock W. Complementary practitioners as part of the primary health care team: evaluation of one model. Br J Gen Pract 1995; 45: 255-258. Burke C, Sikora K. Complementary and conventional cancer care: the integration of two cultures. Clin Oncol 1993; 5: 220-227. Guzley GJ. Alternative cancer treatments: impact of unorthodox therapy on the patient with cancer. South Med J 1992; 85: 519-523. Cassileth BR, Lusk EJ, Guerry D, et al. Survival and quality of life among patients receiving unproven as compared with conventional cancer therapy. N Eng J Med 1991; 324: 1180-1185. Ernst E. Complementary medicine: common misconceptions. J R Soc Med 1995; 88: 244-247. (Received 24 Jan, accepted 5 Aug 1996) Authors' details Department of Clinical Oncology, Royal North Shore Hospital, Sydney, NSW. Stephen D Begbie, MB BS, Oncology Registrar; Zoltan L Kerestes, PhD, Computer Scientist; David R Bell, MB BS, FRACP, Medical Oncologist. Reprints: Dr D R Bell, Department of Medical Oncology, Royal North Shore Hospital, St Leonards, NSW 2065. - To top of article - ©MJA 1996 <URL: http://www.mja.com.au/> © 1996 Medical Journal of Australia.

Stephen D Begbie · Zoltan L Kerestes · David R Bell

Screening for colorectal cancer: too early to be dogmatic The emotive, ethical and economic issues raised by population screening programs remain a challenge ©MJA1996; 165: 68-69 Readers may print a single copy for personal use. No further reproduction or distribution of the articles in whole or in part should proceed without the permission of the publisher. For copyright permission, contact the Australasian Medical Publishing Company Support for screening for colorectal cancer in Australia has been gradually brewing, with reports in the national and international literature, 1-3 and evidence suggesting that colorectal cancer is increasing in prevalence. Despite improvements in surgical technique and adjuvant therapies, overall survival in the symptomatic phase of the disease has remained static. Now a well performed, randomised controlled trial of repetitive faecal occult blood testing has shown, for the first time, a small survival benefit from screening, 1 and evidence from case-control studies suggests that flexible sigmoidoscopy screening may have an even greater mortality benefit. 2,3 In this issue of the Journal, two articles -- a review of screening for colorectal cancer by Macrae ( page 102 ), and a pilot study of flexible sigmoidoscopy screening for colo rectal cancer by Olynyk et al. ( page 74 ) -- highlight this renewed interest in screening for colorectal cancer. Clinical epidemiology and the assessment of screening have evolved into a science, with epidemiologists, clinicians and statisticians collaborating in government working parties throughout the world to assess preventive practices for cancers. 4 In 1996 the momentum for screening prompted an Australian Health Technology Advisory Committee Working Party on colorectal cancer screening to try to sort out the evidence for and against screening, and to establish guidelines for national programs. This is no small task. MEDLINE alone detects over 800 relevant publications on bowel cancer screening, and, as computer searches miss more than 50% of randomised controlled trials, there is obviously a vast ocean of written "evidence" to be found and assessed. 5 Despite reviewing the same body of evidence, collaborating on initial interpretations and adopting a scientific approach to the assessment of screening for colorectal cancer, the Task Forces of Canada and the United States have made different recommendations. 6,7 A stepwise approach to assessing colorectal cancer screening identifies the point in the assessment where the two bodies disagree and the Australian Working Party must adjudicate for the Australian population (Box). 4 The major differences relate to the interpretation of one randomised controlled trial of faecal occult blood testing and two case-control studies of flexible sigmoidoscopy, although the much-awaited results of two further randomised controlled trials of faecal occult blood testing should be available in the near future. 1-3 There is agreement that the Minnesota trial 3 has shown a statistically significant cancer-specific mortality benefit and that this equates to 2.95 lives saved per 1000 people repetitively screened annually with faecal occult blood testing for 13 years. A 10% false positive rate and the 86% quoted compliance would mean an estimated colonoscopy procedural cost alone of over $100 000 per life saved after 13 years in Australia. The United States and Canadian Task Forces have agreed on the efficacy, effectiveness and efficiency of the data (Steps 1-3), but differ in their assessment of the small but expensive cancer-specific mortality benefit of faecal occult blood testing and the allocation of limited resources (Step 4). Interpretation of case-control studies for flexible sigmoid o scopy has remained at the proof-of-efficacy stage (Step 1). Does an 18% difference in rates of flexible sigmoidoscopy for those who died from colorectal cancer equate to a survival benefit in the control subjects who have not died from this disease? 2 The alternative hypothesis is that this difference is due to selection bias inherent in this retrospective study design. 7 The lack of detection of any colorectal cancer in the control group, and the detection of adenoma in only 1% of control subjects, imply no mortality benefit from their 24% sigmoidoscopy rate. 2 True mortality benefit would have to come from an intervention that detected early cancers or high risk adenomas and resulted in successful treatment. This would suggest that the cases and controls are not comparable and that a randomised controlled trial is still required to answer this question. The Fremantle pilot project reported by Olynyk et al. ( page 74 ) detected colorectal cancer at their estimated cost of $500 per screened patient (unpublished data). Thus, the true cost of detecting a cancer with flexible sigmoidoscopy in Australia may be $85 000, with no evidence as yet of a mortality benefit. The same data can and will be interpreted differently by different authors, health departments, societies and foundations. To some extent screening can be supported by the current data, but dogmatic conclusions and recommendations remain controversial and raise issues for discussion. Currently, these revolve around the statistical versus clinical significance of the small cancer-specific mortality benefit of annual faecal occult blood screening; the lack of detection of any cancers or significant polyps in the control groups of case-control studies of flexible sigmoidoscopy to explain any mortality benefit from sigmoidoscopy; and the lack of compliance with many of the screening programs. There is also a lack of research into the potential adverse effects of national screening programs, such as physical complications and problems arising from labelling or mis labelling of people screened (which may have psychological effects and also life and medical insurance repercussions). Even the earlier detection of incurable disease may have adverse effects. 4 The general population's desire for cancer screening may not be as great as that of its advocates; non-compliance would then impact upon efficacy. There is little doubt the emotive and ethical issues raised by population screening programs will challenge us for many years to come. Costs need to be compared with number of lives saved, and screening programs balanced against other programs competing for the limited available health care resources. Programs are often promoted by interested parties with more rhetoric than scientific evidence. The exciting advances of recent years -- that colorectal cancer can be detected and treated in the asymptomatic phase with improvement in mortality -- have encouraged clinical researchers, but the best means of achieving this has yet to be established. It may be that the advances and ethical quandaries of genetic testing hold the key to the future and will be the focus of this debate. Michael J Solomon Colorectal Surgeon Director of Research, University of Sydney, and Central Sydney Departments of Colorectal Surgery, Sydney, NSW Mandel JS, Bond JH, Church TR, et al. Reducing mortality from colorectal cancer by screening for faecal occult blood. N Engl J Med 1993; 328: 1365-1371. Selby JV, Friedman GD, Quesenberry CP, Weiss NS. A case-control study of screening sigmoidoscopy and mortality from colorectal cancer. N Engl J Med 1992; 326: 653-657. Newcomb PA, Norfleet RG, Stoner BE, et al. Screening sigmoidoscopy and colorectal cancer mortality. J Natl Cancer Inst 1992; 84: 1572-1575. Hunt J, Solomon MJ. Screening for cancer: the science behind the rhetoric. Int J Surg Sci 1995; 2: 161-167. Solomon MJ, McLeod RS, Laxamana A, Devore L. Randomized controlled trials in surgery. Surgery 1994; 115: 707-712. US Preventive Sevices Task Force. Guide to clinical preventive services. 2nd ed. Baltimore : Williams & Wilkins, 1996: 89-104. Solomon MJ, McLeod RS and the Canadian Task Force on the Periodic Health Examination. Periodic Health Examination, 1994 update: 2. Screening strategies for colorectal cancer. Can Med Assoc J 1994; 150: 1961-1970. - Register to be notified of new articles by email - - To top of article - ©MJA; 1996 < URL: http://www.mja.com.au/> © 1996 Medical Journal of Australia.

Michael J Solomon

Flexible sigmoidoscopy screening for colorectal cancer in average-risk subjects: a community-based pilot project John K Olynyk, Sina Aquilia, David R Fletcher and Jim A Dickinson ©MJA1996; 165: 74-76. This article has been cited in Sladden MJ, Ward JE. Australian general practitioners' views and use of colorectal cancer screening tests. MJA 1999; 170: 110-113 Readers may print a single copy for personal use. No further reproduction or distribution of the articles in whole or in part should proceed without the permission of the publisher. For copyright permission, contact the Australasian Medical Publishing Company Abstract - Introduction - Methods - Subjects - Data management - Acceptability survey - Results - Subject recruitment - Screening results - Reasons for non-compliance with screening - Discussion - Acknowledgements - References - Author's Details - Register to be notified of new articles by email - - To top of article - ©MJA; 1996 Abstract Objective: To test a pilot screening program for colorectal cancer. Design: Subjects, chosen at random and recruited by mail, were examined by flexible sigmoidoscopy. Participants and setting: Normal-risk, asymptomatic men and women aged 55-59 years recruited from the community, July to December, 1995. Main outcome measures: Number of polyps detected and cancers diagnosed, and compliance with screening. Results: Letters of invitation were sent to 3500 subjects; of these, 2881 were eligible for inclusion in the study and 342 (12%) consented to participate. A further 3.5% of non-compliant subjects attended the screening program after a telephone survey assessing reasons for non-attendance. Common reasons for non-attendance were a lack of interest (30%) or a lack of time, mainly due to work commitments (28%). A third of subjects had polyps and 46% of these were adenomas. Three subjects were found to have adenocarcinoma: in two the cancer was confined to a polyp and treated with polypectomy, and one subject underwent anterior resection (overall prevalence of cancer, 0.9%). The median depth of insertion achieved with flexible sigmoidoscopy was 55 cm (range, 25-100 cm). Median pain level (on a scale of 0 = no pain to 10 = worst pain imaginable) was 2 (range, 0-8.5), and 99% of the subjects would have the test again if required. Conclusions: Flexible sigmoidoscopy was well tolerated and had an acceptable detection rate of adenomatous polyps and early cancer. Subject compliance emerged as a major issue which requires further evaluation to maximise participation in future programs. MJA 1996; 165: 74-76 Introduction C olorectal cancer is the commonest cancer affecting both sexes and isnow the second-commonest cause of cancer-related death in both men and women. 1 Several studies have shown that screening asymptomatic populations may reduce mortality from colon cancer by up to 30%, 2-4 and recently the World Health Organization recommended screening of asymptomatic subjects beginning at age 50. 5 However, in Australia there are no uniformly agreed methods for screening asymptomatic subjects for colorectal cancer. 6 Factors such as screening efficacy, cost, subject compliance and strategies employed to evaluate positive results all influence the choice of screening test. Faecal occult blood testing for colo rectal cancer is relatively cheap, but is limited by a high rate of false positive results and poor sensitivity. 7-9 A recent report also suggests that up to half the mortality reduction observed with faecal occult blood screening may be due to chance selection for colonoscopy. 10 Flexible sigmoidoscopy has been proposed as an alternative screening test. It is more expensive but would prevent more cancer deaths than faecal occult blood testing alone. 8,11 Apart from determining the best screening methods, rates of compliance with screening programs range widely (8%-80%). 8,12 These issues, together with implications for health service resource allocation, have prompted recommendations for pilot programs to determine the efficacy of screening and compliance rates before more generalised screening is introduced. 6,8,13 The Western Australian Department of Health provided funds for such a pilot project at Fremantle Hospital. Thus, we were able to conduct a pilot community-based flexible sigmoid oscopy screening program, between July and December 1995, for colorectal cancer in normal-risk asymptomatic individuals, and in this setting determine (i) yield of screening, and (ii) subject compliance with screening and factors which influence compliance. Methods A flexible sigmoidoscopy facility dedicated to colorectal cancer screening was established at Fremantle Hospital. All procedures were performed on an outpatient basis after informed written consent. No sedation was used. After administration of a phosphate enema, procedures were performed either by a qualified gastroenterologist, or a general practitioner who was undergoing supervised training in flexible sigmoidoscopy. An Olympus TI100 colonoscope (Olympus Optical, Japan) was used, allowing insertion up to 100 cm. Biopsies were taken from polyps seen during the procedure. Subjects with biopsy-proven adenomas were advised to have a follow-up colonoscopy. A computer-generated report was issued to all subjects after the procedure, with instructions to return to their general practitioner for ongoing care. The study was approved by the Ethics Committee of Fremantle Hospital. Subjects We recruited male and female subjects aged 55 to 59 years of age using a computerised database derived from the Western Australian Electoral Commission. Letters were sent to 3500 randomly selected subjects inviting their participation. Exclusion criteria (apart from age less than 55 or greater than 59 years) were: symptoms of recent alteration in bowel habit, constipation, diarrhoea, or passage of blood with bowel motions; previous history of colonic polyps or colorectal cancer; and family history of colorectal cancer. A telephone survey of 200 subjects who did not respond to the initial letter showed that the reason for non-attendance in 14% of these subjects was that they met the exclusion criteria. Data management All data were recorded on a customised database from which reports were generated. We recorded basic demographic data, presence or absence of exclusion criteria, operator information, date of procedure, adequacy of bowel preparation, insertion depth, polyp data (number, size, pedunculated or sessile, biopsy report and date), and follow-up advice. Acceptability survey After the procedure, 77 consecutive subjects filled in a brief questionnaire, which included a standard 10-cm linear analogue pain scale. They marked a 10-cm line (labelled "0 = no pain" and "10 = worst pain imaginable") at a point which corresponded to their level of pain. Results Subject recruitment One hundred and fifty letters were returned, indicating that the subject was no longer resident at the mailing address. As 14% of non-attending subjects were found by the telephone survey to meet exclusion criteria, we estimate there were 2881 eligible subjects. Of those, 342 (12%) consented to participate in the study. There were 200 men and 142 women participants; 95% were born in Australia. Screening results Findings at flexible sigmoidoscopy are summarised in Box 1. The median depth of insertion achieved was 55 cm (range, 25-100 cm; 70% of subjects had at least 50 cm of bowel examined by flexible sigmoidoscopy. Thirty-five subjects (10%) were incompletely prepared with one enema and required a repeat bowel preparation before the procedure. Thirty-five per cent of subjects had polyps -- 46% of these polyps were adenomas, the remainder being hyperplastic or metaplastic polyps. The median adenoma size was 4 mm (range, 1-60 mm). Nineteen of the adenomatous polyps (5.6%) were at least 1 cm in size. One subject with a 6-cm sessile villous adenoma underwent anterior resection. Three subjects were found to have adenocarcinoma -- in two the cancer was confined to a polyp and treated with polypectomy, while the third required anterior resection for a cancer detected at follow-up colonoscopy. The overall prevalence of cancer in this group of subjects was 0.9%. The median pain score attributed to the procedure was 2 (range, 0-8.5). Seventy-six (99%) of these subjects would have the test again if required. Most subjects found the procedure interesting (they were able to watch on a video screen) and worthwhile. Reasons for non-compliance with screening The commonest reasons given for non-compliance were a lack of interest (30%) or a lack of time, mainly due to work commitments (28%) (Box 2). Interestingly, 16% of subjects who did not attend stated that they had either discussed the issue of bowel cancer screening to their satisfaction with their local general practitioner or had been screened for bowel cancer. Seventeen (8%) of the 200 subjects who did not attend as a result of the initial mail-out indicated that they would like to participate as a direct result of the telephone interview and were offered appointments; seven (3.5%) of these subjects have since attended for screening. Discussion The cancers detected by flexible sigmoidoscopy in our study were early cancers, but our three cases represent a detection rate of 8.8 cancers per 1000 asymptomatic subjects aged 55-59. Western Australian data for this age group predict an annual incidence of about 1 per 1000. 1 Our yield of polyps at least 1 cm in size (5.6%) is consistent with the previously reported prevalence of polyps in persons aged 55-59 14 and in asymptomatic Australian men of mean age 66 (3.8%). 15 However, the depth of insertion and number of polyps found in our study are both greater than those reported in several recent studies of flexible sigmoidoscopy: their average depth of insertion ranged from 30 to 50 cm 16-19 and polyp yield ranged from 1% to 4%. 18,19 There is little doubt that population response to screening will be a major determinant of the utility of flexible sigmoidoscopy as a screening tool for colo rectal cancer. The reasons given for non-compliance are similar to those reported for non-attendance in faecal occult blood screening programs. 20 Although the initial response in the pilot program was 12%, the survey of non-compliant subjects demonstrated a significant opportunity for improvement. An additional 3.5% of subjects could immediately be given an appointment at the time of the telephone survey of non-compliant subjects, bringing the compliance rate to 15.5%. Of the remaining reasons determined for non-compliance, most could be addressed by better education of subjects, and rescheduling of screening times to suit the work practices of potential candidates. It remains to be seen how much this would actually improve screening rates. Sixteen per cent of non-compliant subjects reported that they had either been screened for colorectal cancer or had discussed the issue to their satisfaction with their local general practitioner. This may reflect the growing public and general practitioner awareness of colon cancer screening; this has recently been reported from South Australia. 21 There is no doubt that the highest possible compliance should be aimed for, but in a society where currently only 41% of subjects with rectal bleeding seek medical attention 22 it would seem that much education needs to occur to facilitate this process. We have reported the first Australian pilot study of flexible sigmoidoscopy screening of asymptomatic subjects aged 55-59 years in which a high yield of adenomatous polyps and early cancers was found. The procedure was well tolerated. Subject compliance emerged as a major issue which requires further evaluation in order to maximise participation in future programs. This study strongly supports a more broad-scale evaluation of flexible sigmoidoscopy screening of asymptomatic subjects for colorectal cancer and polyps. Acknowledgements We wish to thank Dr Digby Cullen, Mr Graham Cullingford and the Gastroenterology Departments of Fremantle Hospital, Sir Charles Gairdner Hospital and Royal Perth Hospital; Dr Andrew Penman, formerly Chief Health Officer of the Health Department of Western Australia, and the Fremantle Division of General Practice, for their support of this study. References Dobson SK, Penman AG, and 82 others. Clinical health goals and targets for Western Australia, Vol. 2. First report of the Western Australian Task Force on State Health Goals and Targets. Perth: Health Department of Western Australia, July 1994. Mandel JS, Bond JH, Church TH, et al. Reducing mortality from colorectal cancer by screening for faecal occult blood. N Engl J Med 1993; 328: 1365-1371. Selby JV, Friedman GD, Quesenberry CP Jr, et al. A case-control study of screening sigmoidoscopy and mortality from colorectal cancer. N Engl J Med 1992; 326: 653-657 . Newcomb PA, Norfleet RG, Storer BE, et al. Screening sigmoidoscopy and colorectal cancer mortality. J Natl Cancer Inst 1992; 84: 1572-1575. Winawer SJ, St John DJ, Bond JH, et al. Prevention of colorectal cancer: guidelines based on new data. Bull World Health Organ 1995; 73: 7-10. Goulston K, St John J, Bokey L, et al. Guidelines for early detection, screening and surveillance for colo rectal cancer. 2nd edition. Sydney: Australian Gastroenterology Institute and Gastroenterological Society of Australia, 1994. Austoker J. Screening for colorectal cancer. BMJ 1994; 309: 382-386. Lieberman D. Screening/early detection model for colorectal cancer. Cancer 1994; 74: 2023-2027. Solomon MJ, McLeod RS and Canadian task force on periodic health examination. Can Med Assoc J 1994; 150: 1961-1970. Lang CA, Ransohoff DF. Faecal occult blood screening for colorectal cancer: is mortality reduced by chance selection for screening colonoscopy? JAMA 1994; 271: 1011-1013. Lieberman DA. Cost-effectiveness model for colon cancer screening. Gastroenterology 1995; 109: 1781-1790. Blalock SJ, De-Vellis BM, Sandler RS. Participation in faecal occult blood screening: a critical review. Prev Med 1987; 16: 9-18. St John J. Screening for colorectal cancer: "On your marks. . ." Med J Aust 1994; 160: 596-597. Arminski TC, McLean DW. Incidence and distribution of adenomatous polyps of the colon and rectum based on 1000 autopsy examinations. Dis Col Rectum 1964; 7: 249-261. Chapuis PH, Goulston KJ, Dent OF, Tait AD. Predictive value of rectal bleeding in screening for rectal and sigmoid polyps. BMJ 1985; 290: 1546-1548. Krevsky B, Fisher RS. Yield of rescreening for colonic polyps using flexible sigmoidoscopy. Am J Gastroenterol 1994; 89: 1165-1168. Maule WF. Screening for colorectal cancer by nurse endoscopists. N Engl J Med 1994; 330: 183-187. Renneker M, Saner H. Low-cost flexible sigmoid oscopy screening: a community demonstration and education project. J Cancer Educ 1995; 10: 25-30. Sakamoto MS, Hara JH, Schlumpberger JM. Screening flexible sigmoidoscopy in a low-risk, highly screened population. J Fam Pract 1994; 38: 245-248. Lindholm E, Berglund B, Haglind E, et al. Factors associated with participation in screening for colorectal cancer with faecal occult blood testing. Scand J Gastroenterol 1995; 30: 171-176. Weller D, Hiller J, Beilby J, et al. Screening for colorectal cancer: knowledge, attitudes and practices o f South Australian GPs. Med J Aust 1994; 160: 620-624. Crossland A, Jones R. Rectal bleeding: prevalence and consultation behaviour. BMJ 1995; 311: 486-488. (Received 6 Feb, accepted 22 Apr 1996) For editorial comment, see Solomon, page 68; see also Macrae, page 102. Authors' details University Department of Medicine and Department of Gastroenterology, Fremantle Hospital, Fremantle, WA. John K Olynyk , FRACP, MD, Senior Lecturer and Head of Department of Gastroenterology. Sina Aquilia , BA(Psych), Research Assistant. University Department of Surgery and Department of Gastroenterology, Fremantle Hospital, Fremantle, WA. David R Fletcher , FRACS, MD, Professor of Surgery, Head of Department of Surgery. University Department of General Practice, Fremantle Hospital, Fremantle, WA. Jim A Dickinson , FRACGP, PhD, Professor of General Practice. Reprints: Dr J Olynyk, University Department of Medicine, Fremantle Hospital, PO Box 480, Fremantle, WA 6160. E-mail: jolynyk AT uniwa.uwa.edu.au < URL: http://www.mja.com.au/> © 1996 Medical Journal of Australia.

John K Olynyk · Sina Aquilia · David R Fletcher · Jim A Dickinson

Screening for colorectal cancer, 1996 Finlay A Macrae Readers may print a single copy for personal use. No further reproduction or distribution of the articles in whole or in part should proceed without the permission of the publisher. For copyright permission, contact the Australasian Medical Publishing Company Screening average-risk people aged 55 to 70 years for colorectal cancer is now a public health priority in Australia. Pilot studies of faecal occult blood testing are required to find ways of achieving optimal compliance and cost efficiency in the Australian health care setting. Flexible sigmoidoscopy probably should be used as complementary screening but further trials are needed. High-risk groups (family history of colorectal cancer, or previous ulcerative colitis, adenomas or cancer) should already be in surveillance programs. (MJA 1996; 165: 102-105) Introduction - Average risk screening - Above average risk - Conclusion - References - Author's Details - Table 1 - Table 2 - Table 3 Introduction A convergence of events has placed colorectal cancer in the forefront of Australian public health policy formulation. Strategies to control the other major cancers (of the lung, breast and cervix) are now well developed, making it logical that colorectal cancer, as the commonest internal malignancy in Australia, 1 should now receive more attention. At the same time, techniques to detect colorectal cancer at an early (curable) stage have been refined, and large, long-term randomised studies to prove that these techniques can reduce mortality from colorectal cancer are nearing completion. 2-6 Our confidence in determining the outcome of these trials has increased with the development of rigorous methods to assess benefit. 7 Finally, the leading role that colorectal cell and molecular biology has taken in the science of carcinogenesis 8 means that delivery of molecular biological diagnostic services for cancer should already be a clinical service, at least for familial adenomatous polyposis and some other familial colo rectal cancers. Given the state of our knowledge, what should be done now about colorectal screening? Average risk screening Faecal occult blood testing The best chance of cure in colorectal cancer is surgical treatment when the disease is localised to the bowel wall (Australian Clinicopathological Staging System A [ACPS A]) or at least does not involve lymph nodes if it has penetrated through the muscle wall (ACPS B). This means the best chance of diagnosis is before symptoms develop. The most logical method of diagnosis is population screening to identify people with early-stage or premalignant (adenomatous polyps) tumours, but it is very difficult to prove that this will reduce mortality rate. Such proof is required to attract scarce health dollars. Rigorous controlled trials are needed to counter possible biases (e.g., lead-time bias: screening allowing an earlier diagnosis but not altering date of death or the tumour's natural history; and length bias: screening selecting biologically favourable tumours, such as slow-growing ones) and the requirement to analyse on an intention-to-treat basis 9 means recruiting over 100 000 people to adequately test the screening hypothesis. Three large randomised controlled trials of faecal occult blood testing are in progress 4-6 and several have been completed (Table 1). 2,3 The most important completed trial is the Minnesota trial, involving 46 551 subjects studied over 13 years and randomly allocated to annual, biennial or no Hemoccult testing (SmithKline Diagnostics Inc, San Jose, Calif, USA). 2 The trial demonstrated a statistically significant 33% relative reduction in mortality from colorectal cancer in subjects having annual testing. This result has withstood close scrutiny by critics, including those who believed that most of the benefit was attributable to chance because of the low specificity of the rehydrated Hemoccult test used, leading to over 30% of the screened population having a colonoscopy. 10 If the benefit was merely serendipitous, then the chance of a single positive occult blood test versus multiple tests (six were done with each screen) should not be linearly related (which it was), and the odds ratio for tumours in individuals testing positive versus negative to the presence of faecal occult blood would not have reached such high levels, far outstripping almost all other known risk factors. Thus, the Minnesota study shows that faecal occult blood testing does select patients with significant colorectal tumours. The three incomplete European randomised controlled trials are also on track to show a mortality reduction. 4-6 Supporting data come from case-control studies of faecal occult blood testing (Table 2). 11-13 The screening histories of people dying from colorectal cancer (cases) are compared with those of control subjects without apparent disease. A deficit of screening in the cases implies protection to the controls by screening. However, rigorous standards need to be applied to case-control studies to counter the subtle biases, which may account for the generally more favourable levels of protection found when compared with the results of randomised controlled trials. 7 Cohort studies of screening for colo-rectal cancer are curiously missing from the literature. Large cohort studies of diet and other possible risk factors for colo-rectal cancer have been published, 14,15 but none have recorded incidence of prior screening in those in the prospective cohort developing cancer versus those not developing cancer. Screening information is not reported in these studies, which seems a valuable opportunity lost. Many of the biases confounding case-control studies would be overcome in a cohort study of screening. New immunochemical tests have already demonstrated improved sensitivity and specificity, which will enhance the cost effectiveness and efficacy of screening programs. 16 Despite a statistically significant mortality benefit, the absolute number of lives saved per 1000 persons screened for faecal occult blood is small (about three). 2 This, of course, is a corollary of well patient screening (most of the people being screened are both free of disease and have negative results). We need to conduct studies to define cost-efficient procedures for screening, using tests with low false positive rates, and targeting particular communities. Sigmoidoscopy Sigmoidoscopy is likely to be an important adjunct for detection of distal colorectal cancer, as faecal occult blood testing has low sensitivity for rectosigmoid cancers. 17 Case-control studies of sigmoidoscopy screening show protection to the control groups (Table 2), 18,19 but it is difficult to identify the reason for the mortality benefit in terms of polyps removed or successful surgery for cancers detected at an early stage. Well accepted randomised controlled trials have not been done. Flexible sigmoidoscopy should detect 50%-70% of colorectal cancers, so its impact in screened populations is likely to be high. Indications from case-control studies are that protection lasts for 10 years, which augurs well for cost-benefit considerations. 18 Large randomised controlled trials of flexible sigmoidoscopy screening are commencing in Europe. 20 Colonoscopy Even once-off colonoscopy is comparable in cost with breast cancer screening. However, as with flexible sigmoidoscopy, colonoscopy screening does not have enough clinical research proof to be sure of its benefit, although this is probably just a matter of time. 21 Compliance in Australian populations at average risk is unknown. From clinical science to clinical service In summary, faecal occult blood testing is the screening method with the stongest data for deployment. But, should we wait for the results of the additional European controlled trials of screening, or act now on the evidence from the Minnesota trial and other published information? Despite its low sensitivity (about 50% for asymptomatic cancers), 4,21 repetitive screening programs have shown a reduction in mortality from colorectal cancer. Testing is cheap and simple and reasonably well accepted in Australian populations. 22 Provided specificity is high (and thus false positive results low), follow-up colonoscopy is both feasible and cost-manageable. 23 Although the scientific basis for implementing faecal occult blood screening for those aged 50-75 years of age is compelling, the best way to do this in Australia is uncertain. Should it be through dedicated centres providing testing and evaluation, as with breast screening in Australia? Should it be through general practice? through a central electoral-roll-resourced organisation? through hospitals? or through State cancer foundations/councils? These logistical questions need to be answered by pilot trials. 24 Mechanisms to evaluate the results on a population basis must be built into whichever system is introduced. Germany has funded faecal occult blood mass screening for over a decade but has a poorly developed evaluation infrastructure, thus denying the world an important opportunity for assessment. Sigmoidoscopy needs further study before introduction, but sufficient evidence is available to offer sigmoidoscopy to average-risk people in the age group 50 to 75 years who are already in the health care system (case finding). Technical skills and facilities for flexible sigmoidoscopy are limited and their availability must be increased. Issues of cleaning and disinfection, environmental hazards of glutaraldehyde, technical and lesion-recognition training, manpower, support personnel, capital support for equipment for a "type C" (office-based) procedure, all complicate the widespread use of flexible sigmoidoscopy. However, the benefits of being able to examine 50%-70% of the tumour territory of the large bowel make the objective worthwhile. Above average risk Family history For individuals with a family history of colorectal cancer the appropriate recommendations are generally less controversial (Table 3). Many consistent studies demonstrate risks two- to sixfold higher in individuals with first degree relatives with colorectal cancer, the risk relating to the earliest age of onset in the family and the number of first degree relatives affected. 25,26 If there is only one affected first degree relative, age at onset of the cancer is important: if the relative was under 55 years, the risk is six times the average risk (the same as the risk for those with two first degree relatives with onset at any age); if a single affected relative has older-onset cancer, the increased risk to family members is marginal. 25 Thus, average-risk screening is recommended for those families with a single affected relative with older-age onset ( > > 55 years) of colorectal cancer (faecal occult blood testing and five-yearly flexible sigmoidoscopy), but colonoscopy every five years is recommended for those with a first degree relative with early-age onset. 24 If multiple family members are affected in a nuclear family, colonoscopy is recommended for first degree relatives of affected members, either five-yearly or three-yearly, depending on whether two or more relatives are affected. This advice is based on logical grounds of cost benefit: the higher the risk (and therefore prevalence) the greater the positive predictive value of screening, and thus cost-benefit. Protection may be enhanced by annual faecal occult blood testing between colonoscopies. The significance of a family member with an adenoma (as distinct from a cancer) is less clear in defining risks to individuals in the family. Epidemiological studies suggest that adenomas are equivalent to cancers, 27,28 but problems of detection bias make it difficult to use this information for surveillance advice. Nevertheless, a relative with a confirmed adenoma should not be ignored in assessing family history, and for risk assessment purposes it should be considered that these lesions may represent early cancer. Hereditary Non-Polyposis Colorectal Cancer syndrome is suspected when three or more first degree relatives have colorectal cancer (especially right-sided or multiple), with at least one affected family member < 50 years of age or when colo rectal cancer is associated with ovarian, endometrial, gastric, small-bowel, pancreatic, biliary, kidney or ureteric tumours. 29,30 Genotyping for these families is available in Australian research studies, but it may take over 12 months to define the family- specific mutation of the mismatch repair genes responsible. 31 Colonoscopy every two years for affected and at-risk family members is important, with faecal occult blood testing between colonoscopies. Familial adenomatous polyp-osis should also be suspected in families with early-age-onset colo-rectal cancer. Enquiry should be made about polyps or polyposis in affected members and confirmation of the diagnosis sought. Genotyping is available but is still technically difficult due to the large gene responsible ( APC gene); mutations at different sites in the gene are responsible for the condition in different families. 32 Once the mutation in a family is identified in genomic DNA, a family-specific DNA test is easily developed and available for predictive (100% accurate) testing in at-risk family members of any age. Expert genetic counselling is required. Issues of threats to insurance of all types, employment, survivor guilt, prognosis and family planning all need to be handled sensitively and informatively both before and after testing. Screening of APC- mutation carriers needs to proceed as before: annual or biennial flexible sigmoidoscopy screening from 15 to 55 years of age. Those without the mutation are recommended to have average risk screening. They are still at risk for common colorectal cancer. Previous adenomas or cancer: "polyp follow-up" Patients with previous adenomas or cancers face a similar risk for future cancer. 33-36 Although no randomised controlled trials have been reported, several large follow-up studies of patients with adenoma have compared outcomes with suitable control groups -- some with adenomas untreated, some with age-sex-matched population control groups, some with patients with polyps detected by barium enema (not removed) before colonoscopy was available -- and demonstrated a convincing reduction in mortality from regular follow-up. 34,35,37,38 The only exception is patients with small tubular adenoma(s) in the rectosigmoid region, where risk for subsequent cancer is no higher than average and surveillance is unlikely to be of particular value. 35 Intervals of surveillance are controversial but the United States National Polyp Study clearly demonstrated that annual follow-up conferred no benefit over three-yearly follow-up; 39 two- to five-yearly follow-up is recommended, depending on multiplicity, size of index adenoma and, possibly, family history -- all independent risk factors for subsequent neoplastic risk. Ulcerative colitis Ulcerative colitis poses a cancer risk after eight years for total disease and 12 years for left-sided disease. 40 The programs with best results advocate multiple biopsies (18 biopsies from eight colonic sites). Controlled trials have not been performed. 40 In summary, controlled trials of surveillance in these above average risk groups would confirm the recommendations but, on current knowledge, ethical considerations would not permit randomisation to no surveillance. Case-control and cohort studies in these above average risk groups providing information on benefit have not been published. Conclusion The prevalence of colorectal cancer in Australia, its surgical curability if detected at an early stage and recent controlled- trial evidence of mortality reduction by faecal occult blood screening now place colorectal cancer on the public health prevention agenda in Australia. The conservative and influential US Preventative Services Task Force has recently, for the first time, accepted the evidence for benefit as fair, and recommended screening for all persons aged 50 and over with faecal occult blood testing, or sigmoidoscopy, or both. 41 The Canadian Task Force on the Periodic Health Examination also accepts the evidence for mortality benefit, but raises concerns about costs driven by low sensitivity and specificity of the tests used in the Minnesota trial. 42 The optimal processes for implementing screening in a cost efficient manner using up-to-date screening tests require studies in pilot public health programs. Australia needs to move forward in this area, to help control its commonest internal cancer (that touches so many Australian families), and its second-largest cause of cancer mortality. References Coates M, McCredie M, Armstrong B. New South Wales Central Cancer Registry, Cancer in New South Wales, Annual reports 1973-1990. Incidence and mortality. Sydney: NSW Cancer Council, 1991. Mandel JS, Bond JH, Church TR, et al. Reducing mortality from colorectal cancer by screening for fecal occult blood. N Engl J Med 1993; 328: 1365-1371. Winawer SJ, Flehringer BJ, Schottenfeld D, Miller DG. Screening for colorectal cancer with fecal occult blood testing and sigmoidoscopy. J Natl Cancer Inst 1993; 85: 1311-1318. Hardcastle JD, Thomas WM, Chamberlain J, et al. Randomised controlled trial of faecal occult blood screening for colorectal cancer: results of first 107 349 subjects. Lancet 1989; 1: 1160-1164. Kronborg O, Fenger C, Olsen J, et al. Repeated screening for colorectal cancer with faecal occult blood test: a prospective randomized study at Funen, Denmark. Scand J Gastroenterol 1989; 24: 599-606. Kewenter J, Bjork S, Haglind E, et al. Screening and re-screening for colorectal cancer. A controlled trial of fecal occult blood testing in 27 700 subjects. Cancer 1988; 62: 645-651. Gill TM, Horwitz RI. Evaluating the efficacy of cancer screening: clinical distinctions and case-control studies. J Clin Epidemiol 1995; 48: 281-292. Ee HC, Young JP. DNA repair and inherited cancer. J Gastroenterol Hepatol 1995; 10: 108-109. Newell D. Intention-to-treat analysis: implications for quantitative and qualitative research. Int J Epidemiol 1992; 21: 837-841. Lang CA, Ransohoff D. Fecal occult blood screening for colorectal cancer. JAMA 1994; 271: 1011-1013. Selby JV, Friedman GD, Quesenberry CP, Weiss NS. Effect of fecal occult blood testing on mortality from colorectal cancer. A case-control study. Ann Intern Med 1993; 118: 1-6. Wahrendorf J, Robra B-P, Wiebelt H, et al. Effectiveness of colorectal cancer screening: results from a population-based case-control evaluation in Saarland, Germany. Eur J Cancer Prev 1993; 2: 221-227. Saito H, Soma Y, Koeda J, et al. Reduction in risk of mortality from colorectal cancer by fecal occult blood screening with immunochemical hemagglutination test. 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Author's details Department of Gastroenterology, Royal Melbourne Hospital, Melbourne, VIC. Finlay A Macrae, MD, FRACP, Physician and Gastroenterologist. Reprints: Dr Finlay A Macrae, Department of Gastroenterology, The Royal Melbourne Hospital, PO Royal Melbourne Hospital, VIC 3050. To top of article - ©MJA; 1996 < URL: http://www.mja.com.au/> © 1996 Medical Journal of Australia.

Finlay A Macrae