Letters

Balakrishnan R Nair,* Brendan Flynn† * Director, † Medical Registrar, Division of Geriatric Medicine, John Hunter Hospital, New Lambton, NSW 2291. knairATmail.newcastle.edu.au To the Editor: We refer to the recent article by Parslow and Jorm1 and the editorial by Headey2 on the link between pet ownership and health outcomes. There is no evidence that pet ownership per se confers cardiovascular benefits. Indeed, the findings of the study were that pet owners were more likely to smoke, had a higher diastolic blood pressure and a higher body mass index than the non-pet owners. The editorial points out that, based on sociological studies, it is likely that pet ownership does have a positive effect on health, but the medical data demonstrating how this is achieved are lacking.2 Might there be other negative effects of pet ownership on health outcomes? A patient under our care recently demonstrated the potential risks involved in pet companionship for elderly people. An 81-year-old woman who was living independently was admitted after a fall caused by tripping over her delightful Himalayan Persian cat. Her presenting symptom was severe back pain exacerbated by weight bearing. However, no bony abnormality was identified. She had difficulty mobilising initially, and the outcome of her fall was significant morbidity with some loss of her previous mobility, even on discharge. She stayed in hospital for 12 days. A follow-up phone call revealed that the patient was still experiencing difficulty mobilising some 2 weeks after discharge. This case raises the possibility that the risks may outweigh the benefits of pet ownership in elderly people who are already at risk of falls. A MEDLINE search, using the terms elderly, trauma, cat, pet and fall (and combinations of these), did not reveal any relevant literature. A recent case report highlighted other cardiovascular issues relating to cat ownership.3 It described a patient who had recurrent episodes of syncope whenever her cat slept on the right side of her neck. The underlying mechanism was carotid sinus hypersensitivity. She required a single-lead ventricular pacemaker and for the cat to lie on her left side. Anecdotal evidence from colleagues highlighted the danger of “dogs taking elderly patients for walks”, resulting in rotator cuff injuries. Additionally, older patients with peripheral vascular disease and fragile skin have presented with non-healing ulcers from dog scratches. Pet ownership for the purpose of modifying cardiovascular risk factors would seem to be unwise in this population. However, the benefits of companionship and the pleasure derived from pets may outweigh the risk of falls for many elderly patients. Should we be doing more “cat scans” or “pet scans” in older patients?

Balakrishnan R Nair · Brendan Flynn

Michael McDonnell General Practitioner, and owner (with his wife) of Daisy and Cashew, 1/4 Mylne Street, Toowoomba, QLD 4350. To the Editor: Having read the article by Parslow and Jorm,1 I dashed to my surgery — praise the Lord, my diastolic blood pressure was 70 mmHg. So, I raced home again and reassured our labradors that they would not have to be shot. Let’s leave elderly pet owners and their blood pressures alone. Pet ownership is all about companionship, friendship, trust, care for your friend — the really important things in life — not your diastolic blood pressure!

Michael McDonnell

Alan E Dugdale Principal Honorary Research Fellow, Department of Paediatrics and Child Health, Medical School, University of Queensland, Herston, QLD 4006. A. DugdaleATuq.edu.au To the Editor: Chronic suppurative otitis media (CSOM) is a long-term problem which often has serious effects on hearing, speech and learning. Couzos and colleagues have shown that local treatment with ciprofloxacin (CIP) eardrops clears episodes of purulent discharge more efficiently than the commonly used framycetin, gramicidin and dexamethasone (FGD) eardrops.1 This hardly ranks as a “cure” as suggested by the authors. The natural history of CSOM is known2-4 (see Box). The disease commonly starts in infancy with painless perforation of the ear drum and purulent discharge. The perforation is usually central and often large. It remains for several years. During this time there are episodes of painless discharge of foul-smelling pus associated with a blocked ear canal and poor hearing. Between these episodes, the perforation remains, but the ear is usually dry and hearing can be normal or at least adequate. By mid-childhood the perforation often closes spontaneously. In some children this leaves a scarred retracted eardrum, but, in others, fluid collects behind the now intact drum, and this chronic serous otitis media decreases hearing. Eventually, this chronic serous otitis media clears, leaving a scarred, retracted eardrum. Hearing then improves and is often functionally normal. Cholesteatoma and other medical complications are uncommon, but the loss of hearing during childhood has severe social and educational effects on the child. Attempts to hasten closure of the perforation and limit the episodes of purulent discharge have had incomplete success.5,6 Any treatment that hastens recovery is welcome, but we should ask: Does local CIP treatment retain its effectiveness in repeated episodes of purulent discharge? (The most common organisms are Pseudomonas spp which rapidly develop resistance to antibiotics); Does CIP treatment alter the interval between purulent episodes compared with other treatments?; and Is there any evidence that local CIP treatment alters the natural history of the disease or lessens the hearing loss? (it is probably too early to detect this). CSOM is a disease of poverty and overcrowding, but the mechanism leading from social disadvantage to ear disease is not clear. In Cherbourg Aboriginal Community where I work, social and living conditions have improved and CSOM is now much less common than reported by Stuart and co-workers more than 25 years ago.2 I hope that treatment with local CIP eardrops will maintain its promise as a significant improvement in the management of this disease in children who have already acquired it, while we work towards eliminating the disease in the long term. Changes in the incidence of ear disease with age in an Aboriginal community (from Dugdale et al3)

Alan E Dugdale

David R Brewster Clinical Dean, Northern Territory Clinical School, Royal Darwin Hospital, PO Box 41326, Casuarina, NT 0811. david.brewsterATnt.gov.au To the Editor: Although the study by Couzos et al1 is important, I have serious concerns about (i) the lack of “intention-to-treat” analysis and (ii) the implication that the use of ototopical aminoglycosides is unethical and could lead to litigation. The CONSORT statement indicates that analysis by intention-to-treat (ITT) is a key measure of methodological quality in reporting of randomised trials.2,3 Of 147 children randomly allocated to the two treatments in this trial, the primary outcome (resolution of otorrhoea) is only reported for 111 children (75.5%), and the secondary outcomes of healed tympanic membrane perforation in 64 (43.5%), and of improved hearing in 49 (33.3%). In addition, although the difference in cure rates is indeed 24.6% if drop-outs are ignored, the authors report incorrect 95% confidence intervals (15.8%–33.4%, instead of 7.3%–41.8%). Analysis by intention-to-treat means that the 36 children lost to follow-up are assumed to still have ear discharge, so 33 of 75 in the ciprofloxacin group and 43 of 72 in the combined framycetin, gramicidin and dexamethasone group would not have “clinical cure”. This reduces the absolute difference to 15.7% (95% CI, 0–32%; P = 0.07), which is no longer a significant difference. It is also unlikely that the clinical cure rates of 50%–70% in the study can be replicated in the real world of remote Top End Aboriginal communities with a high prevalence of chronic suppurative otitis media (CSOM). Cleaning ears twice a day with gentle syringing with 0.5% povidone-iodine, followed by ototopical ciprofloxacin for 10–14 days is not a feasible intervention among the competing priorities in most Aboriginal communities in the Northern Territory. The really important clinical outcomes for CSOM are the two secondary outcomes of healed perforations and improved hearing, but these outcomes were not significantly improved by ciprofloxacin compared with combined framycetin, gramicidin and dexamethasone. Couzos and colleagues conclude that the use of aminoglycosides in CSOM is unethical and could lead to litigation on the basis of potential ototoxicity. Were this true, it would make this trial unethical. This misuse of ethics and law in the medical literature must be denounced. Nearly all drugs have potential side effects which have to be measured against their potential benefits. The potential ototoxicity of ototopical aminoglycosides (and other antibiotics) is not an absolute contraindication to their use, and has not been documented in any of the randomised controlled trials that have measured hearing before and after use of topical aminoglycosides.4 Couzos and colleagues misinterpret the strength of evidence for changing to ototopical ciprofloxacin. Although it is probably true that ciprofloxacin is superior to combined framycetin, gramicidin and dexamethasone in eradicating Pseudomonas aeruginosa, and for the short-term resolution of ear discharge, it is still unclear whether this transient benefit will be maintained in the long term, or whether resistant organisms will emerge in the middle ear, mitigating any benefit from the new drug. Haphazard use of ototopical ciprofloxacin in Top End Aboriginal communities is likely to result in resistance (indeed there is already anecdotal and unpublished evidence of this), so I believe that its use should currently be restricted to studies and programs whose outcomes are healed perforations and improved hearing (rather than only transient resolution of ear discharge).

David R Brewster

Sophie Couzos,* Traven Lea,† Margaret Culbong,‡ Reinhold Mueller,§ Richard Murray¶ * NACCHO Public Health Officer, National Aboriginal Community Controlled Health Organisation, PO Box 927, Broome, WA 6725; † Former Clinical Project Officer, ‡ Chair, NACCHO Research Subcommittee, National Aboriginal Community Controlled Health Organisation, Deakin, ACT; § Senior Biostatistician and Epidemiologist, School of Public Health and Tropical Medicine, James Cook University, Townsville, QLD; ¶ Medical Director, Kimberley Aboriginal Medical Services Council, Broome, WA, and Associate Professor, School of Public Health and Tropical Medicine, James Cook University, Townsville, QLD. scouzosATtpgi.com.au In reply: Dugdale correctly refers to the natural history of chronic suppurative otitis media (CSOM), and the spectrum of endpoints. The primary endpoint chosen in our trial after ototopical treatment was a dry ear1 (commonly referred to as a “clinical cure” by other trials2), an outcome to be expected after short-term follow-up. Surgical closure of the tympanic membrane (TM) has also been defined as “curing” CSOM. Attaining a dry ear is essential to TM healing, and is therefore a functionally important outcome. Brewster seems to confuse intention-to-treat (ITT) analysis with sensitivity analysis. Patients for whom there is no data after random allocation to study groups fall into the “missing” category, and may be included as “failures” in a sensitivity analysis. This may reveal additional information if missing data occurred differentially (ie, in some way associated with the treatments). However, in an ITT analysis, patients (with recorded data) are analysed in the group to which they were randomly allocated, irrespective of the actual treatment they received.3 Our analysis followed this principle and included all children, irrespective of the completeness of their treatment regimen.1 A sensitivity analysis revealed no new information, which was not surprising as the missing data were lost for (ascertained) reasons exclusively unrelated to the treatment, and double-blinding excluded any differential follow-up efforts by the healthcare workers. Consequently, the missing values occurred randomly and our analysis not only follows the ITT principle but is also unbiased (ie, valid with respect to “missing” patients). We are surprised that our treatment regimen is not feasible in the Northern Territory given that it has been used for years in remote Aboriginal communities in Western Australia. We also confirmed the effectiveness of twice-daily use of ototopical medications, which is simpler than current four-times daily schedules. In 1996, the World Health Organization recommended that topical aminoglycosides (AG) not be used for CSOM because of ototoxicity.4 Such use is also contraindicated by manufacturers.1 Given the availability of a safer alternative, healthcare professionals face potential medicolegal challenges if they choose ototopical AG to treat CSOM. The relative superiority of ototopical fluoroquinolones (FQ) over AGs in effecting a dry ear is likely to persist with repeated treatments, as the risk of bacterial resistance generated in CSOM pathogens appears to be very small,5 and is far outweighed by the risks of resistance found with oral or parenteral FQs. In our trial, bacterial resistance to ciprofloxacin in ear isolates was not demonstrated in the short term. Systemic absorption of FQ through ototopical use is also negligible.5 In Japan, ototopical ofloxacin has been used as treatment for CSOM since 1992. Based on repeated nationwide surveys from 1995, increased FQ resistance attributed to ototopical use has not been seen in chronic otitis media isolates (Professor K Suzuki, Department of Otolaryngology, The Second Hospital, Fujita Health University School of Medicine, personal communication).6 Whether antibiotics can affect the interval between purulent episodes of CSOM is predicated on host and environmental factors, as well as the duration of effective drug therapy. A multifaceted approach to the problem of CSOM, requiring the political will to improve the living conditions of Aboriginal families, access to appropriate primary healthcare, ototopical FQs, and surgery will see a reduction in the rate of this disabling disease.

Sophie Couzos · Traven Lea · Margaret Culbong · Reinhold Mueller · Richard Murray

Terry J Coyne,* Michael G Findlay,† Torukiri I Ibiebele,‡ David W Firman§ * Senior Lecturer, School of Population Health, University of Queensland, Public Health Building, Medical School, Herston Road, Herston, QLD 4029; † Acting Senior Analyst, ‡ Assistant Analyst, Epidemiology Services Unit, Queensland Health, Brisbane; § Team Leader, Surveys and Social Statistics, Office of Economic and Statistical Research, The Treasury, Queensland Government, Brisbane.t.coyneATsph.edu.au To the Editor: While the rates of overweight and obesity among Australian adults, as determined by the Australian Diabetes, Obesity and Lifestyle Study (AusDiab),1 may be alarming to some, they may in fact be underestimates of the true prevalence of overweight and obesity. The AusDiab study design2 and its low response rates indicate that the results will need to be interpreted with caution. Firstly, the AusDiab study design excluded rural and predominantly Indigenous census collection districts (CDs). In Queensland, all CDs selected were capital city or other major urban centres (Rural and Remote Areas Classification, categories 1 and 2);3 thus, people living in major rural centres (such as Rockhampton or Bundaberg) or major remote centres (such as Mt Isa) were excluded (ie, in Queensland, about 20% of the population were excluded). Secondly, another potential bias may have been introduced by the Socio-Economic Indexes for Areas (SEIFA) scores of the CDs sampled in the AusDiab study. For example, the overall SEIFA score for the CDs included in Queensland was 1035 (73rd percentile), well above the state average. Finally, the response rates in the AusDiab study were low: only 29% of those estimated to be eligible, and only 52% of those invited, actually completed the study. Our analysis of risk factors of Queensland-AusDiab participants suggests that these participants may have been more health conscious than the general Queensland population. Rates of smoking reported for men and women were considerably lower in the Qld-AusDiab cohort compared with those in the Queensland phase of the 2001 National Health Survey4 (17.3% and 14.5% v 28.4% and 19.8%, respectively). Compared with results of a Queensland Omnibus telephone survey5 conducted at about the same time, higher proportions of Qld-AusDiab participants reported greater intakes of vegetables (≥ 4 serves/day: 27.4% Qld-AusDiab v 16.4% Omnibus) and fruit (≥ 2 serves/day: 28.9% v 24.3%), and less frequent consumption of fast foods (> 1 day/week: 37.3% v 49.5%). Given the low response rate and possible selection bias in the AusDiab study, we suggest that the overweight and obesity data should be interpreted with caution. Several indicators suggest that these data could be underestimates of the true prevalence of overweight and obesity, and that the AusDiab population may have been of higher socioeconomic status, more health conscious (lower rates of smoking, better dietary intake), and more willing to participate in a lengthy examination than the general Australian population. These factors may all be associated with lower rates of overweight and obesity, and therefore future national surveys will need to take these factors into consideration to obtain more accurate estimates of important determinants of health.

Terry J Coyne · Michael G Findlay · Torukiri I Ibiebele · David W Firman

Adrian J Cameron,* Paul Z Zimmet,† David W Dunstan,‡ Jonathan E Shaw§ * Epidemiologist, † Director, ‡ Research Fellow, § Physician in Diabetes, and Director, Clinical Research; Epidemiology Department, International Diabetes Institute, 250 Kooyong Road, Caulfield, VIC 3162. acameronATidi.org.au In reply: Coyne suggests that, based on comparisons within Queensland, the national prevalence of obesity in our article1 is an underestimate. It should be noted that the Australian Diabetes, Obesity and Lifestyle Study (AusDiab) was designed primarily to produce national, not state-specific, data. Forty-two census collection districts (CDs) were selected Australia-wide, with only six CDs selected within each state. The primary objective of this sample selection was to obtain a nationally representative population, not necessarily one representative of each state. Coyne states that none of the Queensland CDs were in major provincial centres. Of the six Queensland CDs, four were outside Brisbane. From the national sample, 17 of 42 CDs (40.5%) were outside capital cities. As a comparison, 36% of the Australian population lives outside capital cities.2 Regarding selection of CDs, we excluded only those in Statistical Local Areas defined as 100% rural, and those where the Indigenous population made up 10% or more of the overall population.3 This excluded only 5.8% of the total eligible population. If the prevalence of obesity among this group was double the overall prevalence, this would not significantly alter the national rate. While the smoking rates in AusDiab were lower than reported elsewhere, the prevalence of obesity, hypercholesterolaemia and hypertension were in line with trends in a series of surveys over the past 20 years.4 In an extensive analysis of food consumption between AusDiab and the 1995 National Nutrition Survey, the rates of fruit and vegetable consumption were within 4% between the surveys for those most commonly eaten. Since our conclusion was that obesity has increased, the possibility of an underestimate only reinforces our message.

Adrian J Cameron · Paul Z Zimmet · David W Dunstan · Jonathan E Shaw

Johan H A Janssen,* David Henshaw† * Cardiologist, † General Physician, Kalgoorlie Regional Hospital, PO Box 8035, Hannans, Kalgoorlie, WA 6433. Johan. JanssenAThealth.wa.gov.au To the Editor: We read with interest the article by Hung on aspirin for cardiovascular disease prevention,1 and would like to alert readers to the fact that, from the same studies Hung discussed, it is clear aspirin fails to prevent 80% of recurrent serious vascular events, and that one in eight high-risk patients will suffer from another “event” in the next 2 years while taking aspirin.2 Recent studies have triggered discussion about the concept of aspirin resistance and competitive binding issues as possible causes for the observed failure of aspirin, or indeed the increased risk of all-cause mortality when aspirin is used in combination with ibuprofen.3,4 Although it may still be premature to recommend routine testing for aspirin resistance, the possibility that testing might lead to improved strategies for reducing the risk of thrombotic complications means that it should be considered. Another point for consideration is whether primary prophylaxis with aspirin might induce aspirin resistance, thereby nullifying the effect of taking it in the first place. We agree with Hung that the current main alternative to aspirin is clopidogrel, and that this agent could be used in cases in which there is any doubt about the efficacy of aspirin.

Johan H A Janssen · David Henshaw

Joseph Hung Associate Professor, School of Medicine and Pharmacology, University of Western Australia, and Head of Department, Cardiovascular Medicine, Sir Charles Gairdner Hospital, Verdun Street, Nedlands, WA 6009. jhungATcyllene.uwa.edu.au In reply: Janssen and Henshaw are correct to point out that aspirin fails to prevent 80% of recurrent serious vascular events among high-risk patients. However, to put this into perspective, simple treatment with aspirin produces about the same relative risk reduction as treatment with a statin or the angiotensin-converting enzyme inhibitor, ramipril, among patients at high risk of vascular events.1-3 Janssen and Henshaw raise the concept of aspirin resistance and the role of a screening test. However, aspirin resistance is a poorly defined term, and could mean the clinical inability of aspirin to protect individuals from arterial thrombotic events, or laboratory measures indicating the failure of aspirin to inhibit platelet activity. There is currently no specific, accurate, and reproducible measure of the antiplatelet effects of aspirin, nor are there methods that can reliably predict the clinical efficacy of aspirin.4 For now, with high-risk patients, doctors should: ensure that patients comply with aspirin therapy along with other proven preventive treatments; avoid regular concomitant use of non-steroidal anti-inflammatory drugs with aspirin because of the potential for competitive inhibition;5 and consider the addition of clopidogrel to therapy with aspirin, so as to block other pathways of platelet activation not blocked by aspirin, particularly in patients who experience thrombotic complications during aspirin therapy.1

Joseph Hung

Bruce Hadden President, Royal Australian and New Zealand College of Ophthalmologists, Eye Institute, 125 Remuera Road, Auckland, 1005, New Zealand. bruceATeyeinstitute.co.nz To the Editor: The article by Brooks contains valuable forward-thinking for future healthcare management of the increasing burden of chronic illness.1 However, Brooks’s suggestion that non-medical practitioners might perform cataract extraction shows his lack of knowledge of the complexity and potential complications of modern cataract surgery. Modern cataract surgery is the most commonly performed major operation, and one of the most rewarding in lifestyle improvement. It is done under local anaesthetic with almost no discomfort, and recovery is rapid. Thus, the patient sees it as being simple. However, it is far from simple for the surgeon. The small-incision, phacoemulsification technique has made the operation more demanding than ever before. The learning curve is both long and steep. Posterior capsule rupture during phacoemulsification is an ever-present threat, and if it occurs, the sight-threatening complications of cystoid macular oedema, retinal detachment and endophthalmitis all become more likely. The modern, highly technical procedure that Australians demand and deserve is comparable with coronary artery bypass and joint replacement surgery in terms of the skill required. There are three reasons that non-ophthalmologists think cataract surgery is simple. First, it is simple from the patients’ perspective. Secondly, cataract extraction can be done relatively cheaply in developing countries. However, the operation done in those countries is a different procedure, and comparisons are not valid. Thirdly, some unscrupulous ophthalmologists themselves have trivialised the procedure as a means of self-promotion. Brooks and others would pay the operation much more respect if they took the trouble to view a few procedures in real life.

Bruce Hadden

R Frank Gorman Medical Ophthalmologist, PO Box 211 Marrickville, NSW, 1475. rfgormanAThotmail.com To the Editor: Ernst raises the matter of obstacles to research in complementary and alternative medicine. With respect to spinal manipulation therapy as an alternative medical approach to constitutional ailments, such as migraine, the key evidence is the recovery of vision, which occurs with spinal manipulation in appropriately ill patients. These data have not been acknowledged by this Journal because randomised controlled trials have not been performed. Ernst says, “Randomisation is only ethical if there is substantial uncertainty about the best treatment for that patient.”1 Applied to the recovery of vision with spinal manipulation, this ethical principle prevents any randomised trials from being performed in studying that phenomenon. In 1992, I sent 12 consecutive patients demonstrating constricted visual fields to four senior fellows of the then Royal Australian College of Ophthalmologists. The patients were examined by those consultant scrutineers, who agreed that the visual fields were constricted in all occasions. The patients were seen at independent locations, and I was present only on one occasion. The patients were then treated by spinal manipulation under anaesthesia, with immediate recovery of the visual fields being noted on wakening from anaesthesia.2 This recovery of vision merely reiterated many earlier anecdotal demonstrations.3-5 In every case, the scrutineers agreed that the vision had recovered when, at an independent location subsequent to the treatment, they saw the patients. Further, when Stephens and his associates, including me, treated 17 patients by outpatient chiropractic spinal adjustments, that entire group showed immediate improvement in the visual fields, as measured by computerised static perimetry.6 Sletteberg and his associates found that 55% of patients with constricted visual fields of the type under discussion still had the visual disability on re-examination on a mean review period of 7 years after orthodox treatment.7 Kathol and his associates also found that 55% of these patients still had the visual disability at a mean review period of 4 years.8 When the 100 per cent improvement obtained by spinal manipulation is compared with results of orthodox medical treatment (45% improvement at mean review periods of 7 and 4 years), it is clear that spinal manipulation is more effective than orthodox medical treatment, so much so that to repeat the experiment would be unethical. In my personal experience, the main obstacle to research of complementary medicine precepts has been the censorship of dissenting data from orthodox medical literature. The most blatant example of this is the studied neglect of the “tunnel vision information”: the knowledge that vision improves in appropriately ill patients when the spine is manipulated.

R Frank Gorman

Edzard Ernst Director, Complementary Medicine, Peninsula Medical School, Universities of Exeter and Plymouth, UK. Edzard. ErnstATpms.ac.uk In reply: Gorman’s story is characteristic of complementary/alternative medicine (CAM): someone makes an observation inconsistent with current medical teaching, and subsequently becomes convinced that therapy X is “100 per cent” effective. Yet clinical trials are never conducted and therapy X assumes somewhat of a cult status. Its proponents name various reasons why clinical trials are unavailable. In some instances (not in the case of spinal manipulation for recovery of vision), clinical trials do eventually emerge. These show that therapy X does not work. Proponents view this as a confirmation of their conspiracy theory. Eventually the cult status of therapy X becomes established. This dangerous scenario would be avoidable if CAM proponents understood the role of science in testing emerging treatments. It is, of course, not unethical to conduct a randomised trial on spinal manipulation for recovery of vision. Sure, randomisation is only ethical if there is uncertainty, but to deny that uncertainty exists is unreasonable — as is the notion of “censorship of dissenting data from orthodox medical” journals. Gorman’s reference list shows that even CAM journals have resisted publishing the effects of spinal manipulation on vision recovery. My conclusion is simple: science and medical publishing follow certain rules for good reasons. CAM should learn to follow them.

Edzard Ernst

Vivian Lin President, Chinese Medicine Registration Board of Victoria, PO Box 5088, Alphington, VIC 3078. adminATcmrb.vic.gov.au To the Editor: The Chinese Medicine Registration Board of Victoria would like to provide updated information relevant to the debate on the article by Parker.1 All practitioners of acupuncture and Chinese herbal medicine in Victoria are now legally required to register. The Chinese Medicine Registration Act 2000 (Vic) specifically includes transitional arrangements, and the Board has developed a “grandparenting policy” for assessing registration applications until 31 December 2004. There are six key assessment areas for all applicants: adequacy of qualification (minimum requirements); recency of practice; competence; good character; fitness to practise; and having the required professional indemnity insurance, first aid and effective communication arrangements. Details are available at www.cmrb.vic.gov.au. To date, 740 practitioners have become registered, and 11.5% of applicants have had a registration refusal or conditions imposed. After the grandparenting period, new applicants will be required to complete an approved course or pass an examination set by the Board. The Board will consider advanced diploma courses for approval up until December 2007, after which the minimum level will be a bachelor degree. Complaints are handled according to the Act, which is modelled on the medical (and other health) practice Acts. The current Victorian model dictates that the Board include two non-practitioners, one legally qualified member and six practitioners with a minimum of 5 years practice experience. Very specific steps must be taken in dealing with complaints, and 28 complaints have already been investigated. The issues of concern include infection control, advertising, professional ethics and communication with patients. Other boards (not medical practitioners) have asked us to assist with endorsement of their registrants, mainly for acupuncture. The Medical Practitioners Board of Victoria plans to ask medical practitioners seeking endorsement for Chinese herbal medicine to register directly with us. We hope this information will help contribute to informed debate on the regulation of complementary and alternative medicine.

Vivian Lin

Suzanne P McEvoy,* Mark R Stevenson† * Research Fellow, Injury Research Centre, School of Population Health, University of Western Australia, 35 Stirling Highway, Crawley, WA 6009; † Director, Injury Prevention and Trauma Care Division, Institute for International Health, University of Sydney, Sydney, NSW. scordovaATsph.uwa.edu.au To the Editor: Taylor et al found that: “Mobile phone use is common among Melbourne metropolitan drivers despite restrictive legislation” and suggest that this constitutes “a preventable exposure to injury risk”.1 This raises two questions: Does mobile phone use while driving affect road safety? If so, do hands-free devices reduce the risk? In their introduction, Taylor et al cited six publications to provide evidence that the use of a handheld mobile phone while driving increases the risk of a road crash. The studies by Lamble et al2 and McKnight and McKnight3 involved a hands-free device and examined driver impairment, not crash risk. The three papers by Violanti4-6 had significant limitations, including no phone billing information to demonstrate that drivers were using their phones at the time of the crash,4-6 reliance on police accident reports that may have involved more thorough investigations into fatal crashes than non-fatal ones,5 and small sample size with only 14 mobile phone users in one study.6 These limitations reduce the validity of the research. The best of the epidemiological studies was a case-crossover study of 699 drivers in collisions involving property damage only.7 However, the oft-quoted four-fold increase in risk comes from the analysis of mobile phone use in a 10-minute hazard interval before the collision. This does not provide conclusive evidence that these drivers were on the phone at the time of their crash and indicates a statistical association only. Although shorter hazard intervals were also examined, one needs to be wary of the potential for misclassifying post-crash calls as pre-crash calls because the time of collision may be imprecise, mobile phone use is common following a crash and a call to the emergency services may not be the first call made after the event. If we conclude that the data are valid despite these limitations, then the fact that hands-free models did not reduce the risk must be noted. Returning to our questions, although there is good evidence demonstrating driver impairment in laboratory-based studies, the epidemiological research has limitations that need to be dealt with to determine the real-world effect of mobile phone use while driving. We are currently undertaking two large epidemiological studies in Perth, involving about 2000 drivers over an 18-month period. The limitations have been addressed in the design of our studies. Furthermore, the evidence to date suggests that hands-free devices do not confer a safety advantage and this issue should not be ignored in driver education.

Suzanne P McEvoy · Mark R Stevenson

Ric Bouvier Community Safety Consultant, 200 Cotham Road, Kew, VIC 3101. ricbouvier7AToptusnet.com.au To the Editor: In “In this issue” of the Journal of 4 August 2003,1 you write regarding “Dialling drivers” that “the jury is still out on the health effects of mobile phones”. Well, the jury is back with a guilty verdict. In June 2003, Injury Prevention2 quoted an evaluation by the Harvard Center for Risk Analysis that “the use of cell phones by drivers may result in about 2600 deaths, 330 000 moderate to critical injuries, 240 000 minor injuries and 1.5 million instances of property damage in America per year”.3 Taylor et al suggest, “Further interventions aimed at decreasing mobile phone use among drivers should be considered.”4 Occupational safety professionals consider that a worker not complying with the safe practices for using a tool should be offered remedial education. If education fails, they stop the worker using that tool. Wise parents also consider taking away a child’s toy until the child can learn to use it safely. And so with mobile phones used while driving. Driver safety education is not very effective. Police have powers to impound items related to other offences, and so should have powers to impound mobile phones used when driving. The driver could then claim it, say, four weeks later, from the police station on payment of a fee-for-service to the police that covers, at least, the relative value of the expenses of the police. The driver would also incur demerit points. Repeated offences would mean they forfeit the phone or their licence.

Ric Bouvier

Graham J Chalker,* Kenneth H Joyner,† Kelly S Parkinson† * Chief Executive Officer; † Technical Advisor, Health and Safety Committee, Australian Mobile Telecommunications Association, PO Box 4309, Manuka, ACT 2603. kellyATkppr.com.au To the Editor: The claim made in the recent article that mobile phone use while driving is more dangerous than drink driving is misleading.1 The 1997 study by Redelmeier is often misinterpreted and cited for the proposition that driving while using a mobile is the same as driving drunk. However, Redelmeier wrote to the New England Journal of Medicine to correct this inaccuracy, saying, “. . . alcohol circulates in the blood for hours, whereas a telephone call lasts only minutes. The cumulative risks associated with intoxication are greater than those associated with cellular telephones”.2 This is supported by a recent Australian study, which compared the blood alcohol levels of drivers involved in real car crashes, rather than driving simulators, and found the risk of an accident was increased by 25 times at a blood alcohol concentration of 0.08.3 Mobile phones have not been shown to present this level of risk in any research. In 2002 in the United States, alcohol was a factor in about 41% of all fatal traffic crashes and in 6% of all crashes.4 In comparison, data collected by about 20 state highway authorities show that mobile phones were a factor in an estimated one half of one percent of all accidents in the US last year. Furthermore, mobile phone subscribers provide the extra eyes and voice for police in reporting aggressive, reckless or drunk drivers, accidents and other road hazards. Almost a third of all genuine calls to 000 are made from mobile phones.5 A recent US survey found that at any given time only 3% of drivers are actively using their mobile phones,6 although it is legal to use a handheld phone in almost all states. Therefore, Taylor’s overall result that less than 2% of Melbourne drivers use a handheld mobile phone, while illegal in Australia and undesirable, is not unexpected. However, the unrelated and misleading comparison made with drink driving is not supported by the facts. No one is questioning that mobile phone use imposes physical, visual, and cognitive demands on the driver. Although technology can help to address physical and visual factors, education is required to address cognitive factors. The Australian Mobile Telecommunications Association has developed 10 safety tips for mobile phones and driving (see www.amta.org.au) and, by adhering to these simple common-sense practices, drivers can make full, productive and safe use of mobile phones.

Graham J Chalker · Kenneth H Joyner · Kelly S Parkinson

David McD Taylor Director of Emergency Medicine Research, Royal Melbourne Hospital, Grattan Street, Parkville, VIC 3050. David. TaylorATmh.org.au In reply: McEvoy and Stevenson raise some important issues. The first relates to the confusion between driver impairment and crash risk. Intuitively, this association seems valid, as any level of driver impairment could be expected to affect driving skill. However, they are correct to suggest that the two should not be used interchangeably without supporting evidence. Secondly, I agree that the quality of evidence directly linking mobile phone use with crash risk is poor.1-4 This largely relates to the difficulty in confirming mobile phone use at the exact time of the crash. Reported direct observation is uncommon, billing records are inexact, and self-report may be subject to prevarication bias. The use of hands-free devices was not examined in our study, mainly because of difficulties in detecting their use. There is anecdotal evidence of a trend towards the use of these devices while driving. However, while their use might avoid the need to physically hold the phone, they may not significantly diminish driver impairment resulting from distraction. Many questions remain, and I encourage McEvoy and Stevenson in their endeavour to more clearly evaluate the real-world risk of mobile phone use, both handheld and hands-free, by drivers. Chalker et al draw attention to the comparison of crash risk for mobile phone use while driving and drink driving. I acknowledge that interpretation of published studies is confusing. Redelmeier’s statement that alcohol circulates for hours and that a telephone call may last for only minutes relates to individuals. From the highway perspective, when one driver completes a call, another is likely to be starting one and effectively assuming the increased collision risk. This concept is consistent with our findings. Almost 2% of drivers were using mobile phones when they passed our observation points, and were therefore at risk at that time. The exact extent of this risk awaits clarification. Chalker et al provide US alcohol and mobile phone related crash statistics. Unfortunately, the latter were not referenced and their value is therefore questionable. Finally, Chalker et al are to be commended for publishing safety tips for mobile phone use while driving. However, their claim that common-sense practices can make mobile phone use safe is extraordinary and disregards emerging evidence. Indeed, this statement appears to contradict their first safety tip, which states “a hands free device can reduce the physical effort to make and receive calls; however, it alone doesn’t make using a mobile phone while driving safer”.5 At best, therefore, common-sense practices will not make mobile phone use while driving safe, only possibly safer.

David McD Taylor

Donna B Mak,* Graeme H Johnson,† Lewis J Marshall,‡ Jacqueline K Mein§ * Public Health Physician, Department of Health Western Australia, 189 Royal Street, East Perth, WA 6000; † Medical Officer, Derby Aboriginal Health Service, Derby, WA; ‡ Head, Sexual Health Service, Fremantle Hospital, Fremantle, WA; § Public Health Medical Officer, Kimberley Population Health Unit, Broome, WA. makhoATbigpond.com To the Editor: We were pleased to read Chen and Donovan’s editorial which highlighted sex-based inequalities in control of genital chlamydial infection and argued for more screening of men for this infection.1 In the Kimberley region of Western Australia, where rates of genital chlamydial infection are among the highest in Australia, control strategies encompass both sexes.2 Although chlamydial infection was not notifiable in WA until 1993, it has been part of the sexually transmitted infections (STI) control program of the Kimberley Public Health Unit (now the Kimberley Population Health Unit) since the 1980s. Since 1989, regional STI management guidelines have recommended that testing for chlamydial infection (and gonorrhoea, syphilis, hepatitis B and HIV infection) be offered to all patients presenting with STI symptoms or as a sexual contact of an STI patient, and as part of antenatal, prison and well-person’s screenings.3,4 In 1996, empirical treatment for chlamydial infection with single-dose azithromycin (funded by the Kimberley Public Health Unit) was added to the standard treatment regimen, and antibody testing and culture were replaced by nucleic acid testing, which is more transport-robust and sensitive. This led to the introduction in 1997 of active health-service-initiated contact tracing for chlamydial infection (ie, sexual contacts reported by patients with chlamydial infection are actively sought by health staff and offered an STI consultation and empirical treatment). Between 11 June 2001 and 29 June 2002, WA Health Department staff (who contribute over 70% of the region’s STI notifications) notified 94 cases of chlamydial infection in female patients and 56 in male patients.5 Coinfection was common, with 61 patients (41%) also having gonorrhoea and four (3%) also having syphilis. Of the female patients, 30% were tested for chlamydia because they had self-presented with STI symptoms, 32% as part of antenatal or well-person’s screening, 36% because they had been reported as a sexual contact of a patient with STI, and 2% for unknown reasons. The corresponding proportions in male patients were 45%, 7%, 45% and 4%, respectively (Pearson χ2 = 12.6, df = 3; P = 0.006). Prevalence of chlamydial infection in the Kimberley antenatal population (69% of whom are screened for chlamydia) is 3% (95% CI, 2%–6%).6 Prevalence in 93 Kimberley men screened consecutively on admission to prison during 18 weeks in 1998–1999 was also 3% (95% CI, 1%–9%). During this same period, prevalence among 59 Kimberley men and 68 women presenting consecutively as STI contacts was 19% (95% CI, 11%–31%) and 22% (95% CI, 14%–33%), respectively (Mak DB, unpublished data). These data demonstrate that contact tracing contributes significantly to chlamydial case-finding, and support the addition of azithromycin to the Kimberley’s empirical STI treatment regimen. Empirical treatment and contact tracing for gonorrhoea over more than 15 years have been associated with decreases in the rate of gonorrhoea and the male : female ratio of cases in the Kimberley (Box). Seven to 8 years after introducing empirical treatment and contact tracing for chlamydial infection, rates have increased in both sexes, as has the proportion of male notifications (Box). Further progress in control of chlamydial infection requires continued provision of STI screening, treatment and contact-tracing services that are acceptable and accessible to both men and women. Notifications of chlamydial infection and gonorrhoea in the Kimberley region, 1993–2002

Donna B Mak · Graeme H Johnson · Lewis J Marshall · Jacqueline K Mein

Neil R Parker Public Health Physician, Darling Downs Public Health Unit, Public Health Services, Queensland Health, PO Box 1775, Toowoomba, QLD 4350. neil_parkerAThealth.qld.gov.au To the Editor: In May 2000 and December 2001, I vaccinated two women for Q fever (Q-Vax, CSL). Both had negative blood tests (IgG < 1:10 by immunofluoresence) and skin tests. Both had local reactions similar to those described by Mills et al.1 In both women, the skin test became positive after vaccination. The first woman had visited a farm on weekends, but had had no direct exposure to cattle, sheep or goats. Swelling at the vaccination site occurred within 72 hours, forming a lump 70 mm x 30 mm in size and causing significant discomfort. The skin test became positive at the same time. A surgeon excised the lesion 5 months after vaccination, and scarring resulted. The histological appearance was similar to that described by Mills et al,1 including a granulomatous panniculitis. The tissue was weakly positive for Coxiella burnetii by a polymerase chain reaction test (Professor B P Marmion, Institute of Medical and Veterinary Science, Adelaide). The skin test was still positive 7 months after vaccination. The second vaccine recipient lived on a cattle property and was involved with calving. She reported that her skin test became positive 5 weeks after vaccination (an observation confirmed by me a week later). The test was still positive at my final review 4 months after vaccination. Although the swelling at the vaccination site reached 50 mm × 20 mm, it caused little local pain or inconvenience. The lesion resolved spontaneously without scarring. The first of these cases had a much shorter onset period than that described by Mills et al.1 Their article did not document the fate of the skin tests, but based on the two cases I report here, and other cases notified to me by general practitioners, I suspect that prolonged positivity may be the rule rather than the exception.

Neil R Parker

Sandy J Berenger,* John K Ferguson† * Area Infection Control Consultant (and Clinical Nurse Consultant, Hunter Area Pathology Service, University of Newcastle), † Director, Department of Microbiology and Infectious Diseases, John Hunter Hospital, Locked Bag 1, Newcastle, NSW 2310. sberengerAThunter.health.nsw.gov.au To the Editor: Collignon and colleagues decry the reuse of “single-use” medical devices.1 Unfortunately, the focus on reuse of items labelled as single-use detracts attention from some of the more serious issues with cleaning of reusable instruments. All hospitals have cleaning failures that occur because some instruments are virtually impossible to clean. Examples include hollow instruments such as bone reamers, biopsy needles and tissue forceps. The actual sterilisation process (as described under Australian Standard [AS] 41872) is not at issue here. Rather, it is the poor design of instruments, and the lack of any standardised assessment process to determine whether an item is capable of being cleaned against that standard. One study found that most “sterilised” artery forceps had residual tissue, visible by light microscopy, representing an unknown, but real, infection risk.3 Most Australian hospitals do not examine surgical instruments under the microscope for grooves or cracks, and instrument sets remain in circulation for many years. In contrast, the most common “single use” critical items that are reused in many Australian hospitals are electrophysiological stimulation (EPS) and aberrant cardiac pathway ablation catheters; there have been no reports of significant mechanical or patient safety issues from reuse of a wide range of cardiac catheters, including EPS and ablation catheters.4 The sterilisation process itself has been validated for these items.5 At John Hunter Hospital, the process of reuse is controlled by a quality system that is far more stringent than the existing AS 4187 Standard. Devices are used for a set number of times before discard, and each catheter use is tracked to the specific patient and procedure. After cleaning, each catheter is examined under x 10 magnification to detect defects. The catheters are tested electrically at the point of use and patient consent is obtained before the procedure. The John Hunter Hospital program has operated for 6 years with an estimated cumulative cost saving of $6 million (compared with no reuse). Patient outcomes are monitored, and no adverse events have been detected. Clinicians express a high degree of satisfaction with the program. The same standard of equipment design, assessment and cleaning should be applied to all instruments that contact sterile tissue. Whether or not a company chooses to label its product “single-use” should not determine whether the item should or should not be reused. More often than not, such labelling serves to benefit financial return rather than patient safety. Hughes entreats us to cease reuse practices until there is incontrovertible proof of the safety of reuse.6 This statement should also apply to routine surgical items. In this era of zero risk tolerance, perhaps the consent process should make patients aware that reusable instruments processed under AS 4187 cannot be guaranteed to be free from human tissue contamination.

Sandy J Berenger · John K Ferguson

Clifford F Hughes Head, Department of Cardiothoracic Surgery, Royal Prince Alfred Medical Centre, Suite 304, 100 Carillon Avenue, Newtown, NSW 2042 (and former Chairman, Therapeutic Device Evaluation Committee). clifford.hughesATemail.cs.nsw.gov.au In reply: Berenger and Ferguson correctly raise the issue of sterilisation procedures for devices used in surgery. They have also described specific measures taken at their hospital for a specific device and, more importantly, have developed a system to ensure the highest quality of sterilisation process in a medical device. Of course, the use of any surgical device should be subject to the strictest sterilisation procedures. Most reuseable surgical instruments do have documented sterilisation protocols which include verification of the process used. All surgical instruments, whether designed for reuse or not, whether used for the first time or the tenth time, should be subject to the scrutiny, surveillance and meticulous records demonstrated by the John Hunter Hospital system. This hospital is to be congratulated on its attention to detail. Were similar stringent protocols in place across all disciplines and in all hospitals, the debate would cease to rage. More importantly, many devices could be safely and efficiently reused. Others may be considered too difficult to resterilise. Nevertheless, asepsis would, once again, be positioned where it belongs, as one of the key principles of surgery.

Clifford F Hughes

Bryan G Walpole Emergency Physician, Australian Antarctic Division, Channel Highway, Kingston, TAS 7050. bwalpoleATtassie.net.au To the Editor: Your otherwise excellent issue on chronic illness (1 September 2003) was timely and appreciated. However, the article by Zajac on the future of public hospitals1 left me pondering how frequently he patrolled the wards and the emergency department. Most public hospitals have undergone the very revolution he adumbrates. Patients now arrive with automated medication records and problem lists from their general practitioner; GP liaison doctors from the Divisions attend discharge planning committees; discharge summaries are delivered by fax on discharge; multidisciplinary clinics abound for complex and chronic illness, but invited GPs claim that time commitments and insufficient payment often preclude attendance; there are target waiting times for clinic appointments; often there is a quality assurance unit, with a complaints or grievance procedure; day surgery and day of admission surgery is now the norm (and strict guidelines help control the morbidity Zajac bemoans), with vastly improved throughput; endoscopy and emergency cardiac catheterisation or angioplasty on demand are commonplace; we now acknowledge, document and rectify system errors with alacrity, without the rancour and recrimination of years ago; and evidence has replaced the wise maxims of the physician. Admittedly, all is not rosy and funding remains a perennial problem, but within available resources the public hospital is a completely different place from 15 years ago. A major issue, and Zajac agrees, is the place of general medicine in the public hospital, being rapidly subsumed by sub(super)-specialists together with emergency physicians, as they are available round the clock, skilled and equipped to perform the assessment and early management of most medical patients, while the physicians are in rooms or at home. We welcome the presence of general physicians in the emergency department, and encourage twice-daily rounds on admitting day with shared care, but so far the rhetoric of general medicine has rarely been matched by attendance. The real challenge for public hospitals at present is to effectively manage and discharge frail elderly patients, and those with cognitive impairment, thus keeping beds free to reduce access block; otherwise general medicine may suffer the fate Zajac reserves for public hospitals and become “a thing of the past”.

Bryan G Walpole

Jeffrey D Zajac Head, Department of Medicine, Austin Hospital, Level 7, Lance Townsend Building, Studley Road, Heidelberg, VIC 3084. j.zajacATunimelb.edu.au In reply: Walpole and I agree that public hospitals have changed significantly. Where we seem to disagree is that he suggests that we have got to where we are going and all the problems have been solved. Walpole clearly works in a different world from me. Even a short visit to the wards and emergency department reveals that, despite good will, planning and many of the changes Walpole lists, things are far from perfect. System errors, major and minor, occur far more commonly than they should, elderly patients spend more time as inpatients than they should, and stresses in the system continue to impair quality and efficiency. I think we need to keep working on these issues, and not pretend that they are fixed. I note with dismay the description of general physicians occasionally visiting Walpole’s emergency department, while other specialists work diligently, 24 hours a day, to heal the sick. These comments demonstrate one of the main problems with doctors in public hospitals, namely, the territorial imperative in full flight. We should be finding ways to work together.

Jeffrey D Zajac

Ron J Lord Editor, Healthcover, 28 Hereford Street, Glebe, NSW 2037. hcoverATihug.com.au To the Editor: The Editor’s article on health reform and the Australian Health Care Summit,1 in which he expressed sentiments with which I agree, included a Box setting out the “egalitarian and socially cohesive principles underpinning Australia’s healthcare” reaffirmed by the Summit. However, the Box contained a Christmas tree and an invitation to readers to enter a poem in the MJA’s Christmas Competition 2003. Among the lines were: “’Tis Christmas, the season to be kind”. While obviously the result of a glitch in the production process, you managed — much to the envy of other editors and publishers seriously wounded by such glitches (to the extent that entire print runs have had to be pulped and then reprinted) — to fall on your feet. I could not think of a better (or more comprehensive) set of principles to underpin our healthcare system than those embodied in the message and spirit of Christmas. Perhaps God moves in mysterious ways.

Ron J Lord

Robert A Jones Specialist Gynaecologist, Adelaide Private Menopause Clinic, Memorial Medical Centre, 8/1 Kermode Street, North Adelaide, SA 5006. robjonesAT senet.com.au To the Editor: 9/15 was disaster day at the MJA.1 Not only was the Editor guilty of printing perseveration, but his “Box” seems to have been transmogrified from . . . “(the) socially cohesive principles underpinning Australia’s healthcare” to an invitation to “expose” the readers of the Christmas journal to some “witty prose”. Perhaps the “healthcare dialogue” has indeed been reduced to rhyming couplets, possibly accompanied by the health ministers fiddling while the rest of us burn?

Robert A Jones