Article Types

Letters

Nicotine replacement therapy: evidence from observational studies versus clinical trials

To the Editor: A “real world” study of smoking abstinence caught the attention of Australian media recently, who primarily focused on the commentary that “cold turkey” was the most successful approach for quitting smoking. Alpert and colleagues1 assessed the effects of nicotine replacement therapy (NRT) alone and/or in combination with behaviour counselling in 787 adult smokers from Massachusetts who had recently quit smoking. The participation rates at baseline and waves 2 and 3 were 46%, 56% and 68%, respectively. At each follow-up, almost one-third of participants reported that they had relapsed. Relapse rates were similar, regardless of NRT participation. This contradicted the higher quit rates seen with groups given NRT compared with the placebo or control groups reported in meta-analyses.2-4 Among previously heavy smokers, the lowest relapse rate was in those who received NRT and counselling; and among previously light smokers, the relapse rate was the lowest among those who did not receive NRT or counselling. In both groups, those who received only NRT had the worst relapse rates, a finding which reinforces the importance of adjunct counselling. Participants in the Alpert et al study1 self-reported NRT use. Quit status was not validated biochemically, which fails the Russell Standard5 of criteria applied to smoking cessation trials. Information on NRT dose, adherence, administration technique and reasons for shorter courses (eg, side effects, cost or perceived lack of benefit) were lacking. The longer term impact of NRT cannot be deduced from this study. The quality and quantity of psychological support received by each participant group was also unknown. It is unclear whether the study was adequately powered, given the small numbers of patients who completed a recommended course of NRT. Moreover, differential loss to follow-up threatens the study’s internal validity. Multiple attempts are often necessary before a smoker can successfully quit. Repeated yearly access to courses of NRT, as allowed under the Pharmaceutical Benefits Scheme (a 12-week supply of patches is allowed each year for clients entering a comprehensive smoking cessation support program), may confer a benefit in the longer term. There is no evidence for the effectiveness of cold turkey cessation, especially in moderate to heavy smokers. Nevertheless, those determined to quit without pharmacotherapy or additional support should be encouraged to try cold turkey cessation.

Johnson George

“Blunderburg” revisited

“Blunderburg” revisited is a very well written review of an important, well researched and well written book, Deadly healthcare, which describes Dr Jayant Patel’s disastrous term at Queensland’s Bundaberg Hospital. The review notes that the former Federal Health Minister Michael Wooldridge pointed out that Dr Patel ...

John A Buntine

Geo10130

No more excuses: fracture liaison services work and are cost-effective

To the Editor: The editorial by Seibel1 was timely, given the promotion in February last year by the New South Wales Agency for Clinical Innovation of an osteoporotic refracture prevention model of care. The evidence presented by Seibel is compelling — osteoporosis is a serious, undermanaged and preventable problem, and there are no more excuses for not instituting refracture prevention protocols in major teaching hospitals. Not only do these programs work to prevent further patient morbidity and mortality, but they are cost-effective in reducing the burgeoning public hospital costs associated with recurrent fractures and hospital admissions. We question the delay in implementing such programs. One cost analysis showed that treating 214 patients saved $156 713 and reduced hospital stays by 270 bed-days over a 2-year period (John Van der Kallen, Rheumatologist, Hunter New England Local Health District, personal communication). More than 10 years ago, we demonstrated that minimal trauma fractures were inadequately managed and preventable, and outlined a cost-effective clinical pathway for monitoring and treating these patients when they presented through the emergency department.2-5 Had this program been instituted by the medical administration at that time, there would have been a saving over a 10-year period of more than $2 million by one major Sydney teaching hospital alone. Despite much talk and “hype” on the part of medical and allied health professionals, medical administrators and government agencies, nothing has eventuated. Unless there is an injection of funds from health departments and a willingness from hospital administrators to implement such programs, we believe that “nothing” will be what continues to happen.

David Spencer · Graydon Howe · Nicholas Manolios

Child health Letters 2 April 2012 Free

Exploring melatonin prescribing among customers of compounding pharmacies in Australia

To the Editor: In Australia, when melatonin is requested in doses higher than those available in preprepared formulations, in different dosage forms, or for people under 55 years of age, private prescriptions and extempora-neous preparations are often used. There is evidence of efficacy of melatonin in shiftwork-related sleep disorders, jet lag, circadian rhythm disorders, and for older people with chronic insomnia, but not for insomnia generally.1-3 There is concern over increasing use of melatonin in children, but no current data exist for actual melatonin usage patterns in Australia. In September 2010, we conducted a 2-week prospective drug use audit of melatonin prescriptions dispensed to patients by Australian compounding pharmacies. All pharmacies of the Professional Compounding Chemists of Australia (PCCA) (n = 153) received audit forms and explanatory information sheets, followed up by two telephone calls. The audit form requested patient details, the melatonin prescription, prescriber, dose amount and formulation prescribed, directions on prescription, and purpose of medication. This study was approved by the Human Research Ethics Committee of the University of Sydney. Forty-one pharmacies completed 228 audits, a response rate similar to recent pharmacy-based surveys.4 Also, 42 pharmacies estimated melatonin prescriptions in the audit period without completing patient details. The demographic details of respondents (Box) were similar to those in a previous survey of Australian compounding pharmacies.5 A total of 1463 melatonin prescriptions were reported as dispensed in the 2 weeks by 83 pharmacies (17.63 per pharmacy). In the detailed audit, the median age of people for whom melatonin was prescribed was 12 years; 56.4% (128/227) were male; the average dose prescribed was 4.3 mg ± 2.5 mg (range, 0.5 mg–20 mg); the most common reason for prescribing melatonin was to help sleep in cases of attention deficit hyperactivity disorder (ADHD); and paediatricians were the most common prescriber (43.0%; 96/223). Analysis of the non-responders showed that responders were not different to non-responders in age, sex, years of experience or pharmacy prescription volume. Extrapolating the results, 70 132 prescriptions (17.63 × 26 × 153) are estimated to be compounded in the 153 compounding pharmacies annually. This staggering figure does not include non-PCCA pharmacies, compounding hospital pharmacies, melatonin purchases without prescription (generally via the internet), or Circadin (Neurim Pharmaceuticals) prescriptions. Circadin was not included in our study as it was introduced in mid 2010 and there had been only a few sales by September 2010, and it is approved only for people over 55 years of age with primary insomnia. In conclusion, we found that melatonin was frequently dispensed, with many cases of off-label use, to both adults and children, particularly for insomnia in children with ADHD and autism. Melatonin has limited long-term safety data, and the long-term effect on gonadal development, particularly with high doses, is unclear. The efficacy and safety of melatonin in children will only be established through well designed trials of high methodological quality and sufficient sample size. Melatonin prescription details for 227 patients Demographic details of patients and prescribers Proportion or mean ± SD (range) (n = 227) Details of patients for whom melatonin was prescribed Age (years) 22.8 ± 20.9 (1–83) Age bracket 0–2 years 1.4% 3–5 years 10.1% 6–10 years 32.0% 11–18 years 19.6% 19–34 years 8.7% 34–55 years 19.6% > 55 years 8.2% Male 56.7% New prescription 29.1% (42.3% using > 6 months) Details of prescribers (from 227 audit forms*) Type of prescriber General practitioner 41.4% Paediatrician 43.2% Sleep specialist 5.7% Psychiatrist 4.8% Other specialist 3.5% Reason for prescription† Primary insomnia 26.4% Secondary insomnia 14.5% Jet lag, travelling, shift worker, CRD 12.8% Help sleep in children with ADHD 24.2% Help sleep in children with autism and behaviour problems other than ADHD 19.4% Anxiety, trauma, stress and sleep problems 3.5% Sleep problems related to pain and cancer 0.8% Sleep problems related to other comorbidities (gastro-oesophageal reflux disease, Grave’s disease) 0.8% Unsure of reason 0.8% Dose (mg) (n = 213) 4.3 ± 2.5 (0.5–20) Total amount prescribed for liquid formulations (mL) (n = 99) 55.2 ± 53.2 (5–300) Total amount prescribed for solid formulations (number of capsules, tablets, troches) (n = 123) 72.9 ± 37.9 (15–300) Repeats authorised (n = 221) 2.3 ± 2.1 (0–10) Prescription duration (months) (n = 200) 7.9 ± 9.7 (0–60) Formulation prescribed† Tablets 3.5% Capsules, slow release capsules 49.7% Liquids (suspension, oral, sublingual drops) 43.5% Troches 2.6% CRD = circadian rhythm disorder. ADHD = attention deficit hyperactivity disorder. * Some data missing on one record of 228, so 227 used for tabulation. † Percentages may not add to 100% because of some missing data, and some patients may have reported two reasons.

Jane Nikles · Victor Lo · Jennifer A Giam · Bandana Saini

Neurocysticercosis in Australia: still free of autochthonous cases?

To the Editor: I have read two recent reports on neurocysticercosis in the Journal.1,2 After performing a literature search for Australian cases of neurocysticercosis (PubMed search, using the terms “cysticercosis”, “neurocysticercosis” and “Australia”), I found reports of 39 patients, and the reports of 33 of these patients were published in the past two decades. This suggests that the prevalence of neurocysticercosis in Australia is rising, or that it has been increasingly recognised and reported in recent years. As expected in a developed country, more than three-quarters of the patients were immigrants from neurocysticercosis endemic areas, and the remainder were Australian residents who had travelled to endemic regions. So, although it appears that Australia is free of locally acquired neurocysticercosis, it is possible that some immigrants who developed the disease while living in Australia were not infected overseas, because some of them developed the disease more than 10 years after they migrated from their home countries. The occurrence of neurocysticercosis among people returning from endemic areas to cysticercosis-free countries shows that cysticerci may remain asymptomatic for a long time in the nervous system or may become symptomatic years (or even decades) after infection.3 Indeed, certain forms of neurocysticercosis, including calcifications, chronic arachnoiditis, subarachnoid cysts and even spinal cysticerci may manifest a long time after infection. However, the single cysticercus granuloma causes symptomatic disease in the first few months after infection;4 this form of the disease occurs mainly in people who have not had previous infection and involves an acute inflammatory reaction to the implantation of one cysticercus in the brain parenchyma. At least seven of the immigrants to Australia with neurocysticercosis had this form of the disease, and some of them developed symptoms up to 3 years after arrival, suggesting local acquisition of the disease from a contact infected with Taenia solium. Unfortunately, case reports and case series of neurocysticercosis diagnosed in Australia do not include information on whether household contacts of diagnosed patients had been tested for carriage of Taenia. Increased awareness of the mechanisms of disease transmission for neurocysticercosis will help to reduce further spread of this zoonosis.

Oscar H Del Brutto

Ethics Letters 19 March 2012 Free

Competence and capacity at the end of life: uneasy paternalism

To the Editor: Le and Chapman’s article1 on capacity at the end of life raises a number of timely issues, given our ageing population and the autonomous rights of individuals in end-of-life decision making.2 The authors made a best-interests decision, based on the patient’s humanity and their responsibility not to let him die “alone, cold and probably in pain”, contrary to his “decision” to die what would not be “a good death”. This stance can be problematic because best interests or good death are entirely subjective, and doctors who provide treatment to a competent patient may be committing trespass.3 Thus, the question of whether he was capable of making a decision to die “a bad death” is possibly more crucial. Structured capacity assessment is beneficial for the peace of mind of clinicians, patients and family. This patient lay on the floor “because he wished to do so” — a “limited realistic choice”. He was delirious and therefore deemed incompetent. Did the delirium affect his ability to weigh the pros and cons of staying on the floor and refusing hospital admission? Assessment of capacity to consent to medical treatment involves determining whether the patient is capable of understanding the ramifications of treatment and its alternatives (including no treatment). His premorbid choices (precedent autonomy)4 of living a squalid, isolated existence and refusing treatment for some time must also be noted. Yet capacity is dynamic and can change over time. Careful capacity assessment can justify decisions made on behalf of patients.

Sharon G Reutens · Carmelle Peisah

Ethics Letters 19 March 2012 Free

Competence and capacity at the end of life: uneasy paternalism

In reply: We thank Reutens and Peisah for their response to our article.1 We agree that careful capacity assessment is of critical importance — a patient’s capacity should be assessed rather than assumed. Delirium can often affect capacity due to the impact of attentional deficit on the process of decision making.2 In our case, the patient could neither reason through the ramifications of his decision to stay on the floor nor be involved in a logical discussion as to why we had concerns about his choice. Indeed, he had not chosen to be on the floor but was there because of his fall, his delirium and his inability to rise. However, we do caution that clinicians should trust their own clinical decisions when these are based on sound assessment. Choosing not to make hard decisions for fear of litigation (eg, committing trespass) does neither the patient, the community nor our profession any favours.

Brian H Le · Michael D Chapman

Anaesthetics Letters 19 March 2012 Free

Should opioids be used for chronic non-cancer pain?

To the Editor: Kapur and colleagues correctly assert that the Declaration of Montréal states that “access to pain management is a fundamental human right”.1 The Declaration was proposed by International Association for the Study of Pain (IASP) delegates to the International Pain Summit and was approved by the IASP Council. However, Kapur et al incorrectly assert that the Declaration leaves the position of diagnosis uncertain, and that “the only specific treatment modality mentioned is opioid therapy”. Article 3 of the Declaration recognises: The right of all people with pain to have access to appropriate assessment and treatment of the pain by adequately trained health care professionals.2 Footnote 6 includes the need for “educational programs regarding pain assessment and treatment in all of the health care professions”. Thus, a label of “chronic pain” does not lead to a right to opioid treatment without proper assessment and consideration of treatment options. Footnote 6 refers to a range of treatment options, such as pain medications, including opioids and other essential medications for pain, and best-practice interdisciplinary and integrative nonpharmacological therapies, with access to professionals skilled in [their] safe and effective use ...2 It would be hard to describe the carefully worded articles, obligations and footnotes of the Declaration as “dogma, moral coercion or forays into jurisprudence”.1 At its General Assembly in 2011, the World Medical Association (WMA) supported measures to improve access to pain management. Dr Mukesh Haikerwal, Chair of the WMA, said: Physicians and other health care professionals have an ethical duty to offer proper clinical assessments to patients with pain and to offer appropriate treatment.3 Further, a WMA resolution asserted that people facing pain had a right to appropriate pain management, including effective medications such as morphine. Denial of pain treatment violated the right to health and might be medically unethical.3 It is puzzling that Awerbuch feels that describing chronic pain as a disease means that “the patient becomes the sole arbiter of whether he or she is ill. The prescribing doctor has no means by which to objectively determine treatment outcomes”.4 In the article to which he refers,5 and in other reports including Australia’s National Pain Strategy,6 the “disease” of chronic pain is described in terms of physical, psychological and environmental factors that require assessment by health professionals with adequate knowledge and training. This is not just a labelling exercise.

Michael J Cousins

The need for genetic studies of Indigenous Australians

To the Editor: The continuing integration of genetic technologies into clinical medicine is providing opportunities for health care improvement. This has the potential to reduce health disparities between Indigenous and non-Indigenous Australians in several ways: improving our understanding of disease pathogenesis, obtaining a perspective from ...

Gareth S Baynam

15 1
Endocrinology Letters 19 March 2012 Free

Medication to prevent breast cancer — too much to swallow?

To the Editor: We read with interest the recent article by Harvey and colleagues, which eloquently outlines the benefits and risks of selective oestrogen receptor modulators in the prevention of breast cancer in women at moderate-to-high risk. Another oral medication that may prove to be of benefit in reducing the risk of breast cancer is the ...

Jerry R Greenfield · Ann I McCormack

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A survey of injuries sustained in falls from ladders among patients at an inner-city trauma centre

To the Editor: Recent media reports related to Ian “Molly” Meldrum1 are a timely reminder, once again, of the risk of physical injury posed by a fall from a ladder. We carried out a survey of injuries sustained in falls from ladders among patients presenting to the Royal Prince Alfred Hospital (RPAH), an inner-Sydney major trauma centre, between January 2009 and December 2011. We linked data from the hospital trauma registry with data from the New South Wales Department of Health Centre for Epidemiology and Research. The trauma registry routinely collects data on all injury-related admissions and trauma team activations. NSW Health provided data from a free-text search for the term “ladder” within the presenting problems, triage text and diagnoses in the electronic medical records of all patients who presented to the RPAH emergency department (ED) during the period studied. For comparison, we also constructed a survey of injuries sustained by pedestrians struck by a motor vehicle. We used trauma registry data, from a previous study of patients with such injuries, for 409 consecutive patients admitted during 2008–2010. The study was approved by the Sydney Local Health District Ethics Review Committee (RPAH zone). We identified 331 ED presentations related to any ladder incident. Of these, 136 were available in the trauma registry for analysis. The mean age of patients was 54 years (SD, 17 years; 95% CI, 51–57), and a significant proportion (37; 27%) were 65 years or older. No inpatient deaths were reported. The most common body regions injured were upper limb (54; 40%) and head (41; 30%). Severe head injuries were sustained by 14 patients (10%) (Box). Although the proportion of patients with major trauma (injury severity score, > 15) was consistent with previous trauma registry reports,2,3 the proportion with head injury was much higher and may be related to the older age in this cohort. One recent study suggested that the incidence of major injury from ladder falls is increasing, particularly among older people.4 Many presentations for minor injury were not captured by the trauma registry; however, unlike previous reports, we included all patients requiring initial assessment by the trauma team. The proportions with severe head injury (head Abbreviated Injury Scale score, ≥ 3), intensive care admission and major trauma were similar between patients who fell from ladders and pedestrians who were struck by motor vehicles (10% v 12%, P = 0.50; 10% v 9%, P = 0.79; 12% v 15%, P = 0.30, respectively). Based on the significant proportion of people sustaining severe head injury, new ladder-safety initiatives are required, particularly targeting those aged 65 years and over. Demographic and injury profile of patients with injuries sustained in a fall from a ladder who were admitted to an inner-Sydney trauma centre, January 2009 – December 2011 (n = 136) Variable No. (%)* 95% CI Age, years (mean, SD) 54 (17) – Male 111 (82%) 76–89 Time of incident After hours† 30 (22%) 15–29 Weekend 37 (27%) 20–35 Height of fall < 1 m 29 (21%) 14–28 1–5 m 105 (77%) 69–83 > 5 m 2 (1%) 0–5 Hospital admission 95 (70%) 62–77 Intensive care admission 14 (10%) 5–15 Length of stay in hospital, days (mean, SD) 5.4 (8.9) – Injury severity score (mean, SD) 7 (5) – Major trauma‡ 16 (12%) 6–17 Body region injured Head 41 (30%) 22–38 Severe head injury§ 14 (10%) 5–15 Upper limb 54 (40%) 31–48 Lower limb 37 (27%) 20–35 Chest 14 (10%) 5–15 Severe chest injury¶ 7 (5%) 1–9 Abdomen 3 (2%) 0–5 Vertebral column 26 (19%) 12–26 Spinal cord injury 9 (6%) 2–11 AIS = Abbreviated Injury Scale. * Unless otherwise specified. † Any time between 18:00 and 08:00. ‡ Injury severity score > 15. § Any significant intracranial bleed, oedema and/or major skull fracture; head AIS score ≥ 3. ¶ Includes flail chest, major haemothorax or pneumothorax and mediastinal injury; chest AIS score ≥ 3.

Michael M Dinh · Helen L Stark · Kendall J Bein

Inpatient subacute care in Australia: perceptions of admission and discharge barriers

To the Editor: The recent article by New and colleagues1 is an important piece in the “bed-block” picture, providing insight into perceived difficulties for patients on discharge, as a result of insufficient appropriate facilities. The authors suggested that “Redistributing proposed funding for inpatient subacute beds to measures for overcoming these barriers” may improve patient flow through the whole hospital system. This idea fits well with current federal health policy that “bed equivalents” are an important aspect of innovative and flexible models of care for rehabilitation services in Australia.2 Most states are reviewing how rehabilitation services are best designed to ensure the most effective use of limited resources, both in terms of programs and workforce. Improving the coordination of programs managed by the various levels of government, across health, disability and the aged care sectors, will help overcome the barriers identified in this study. The Australasian Faculty of Rehabilitation Medicine applauds efforts to increase research on rehabilitation and patient care, and supports federal and state initiatives providing increased resources for subacute care, both within hospitals and in the community. Investment in rehabilitation services at the community level is one of the most viable solutions and will meet the needs of an ageing population. Effective community care and the proposed National Disability Insurance Scheme (http://www.ndis.gov.au), if well executed, will reduce the burden on other parts of the health and aged care sectors and help ease the burden on hospitals.

Kathleen McCarthy

We’ll drink to that: the 200th anniversary of Australia’s oldest hospital

To the Editor: The entertaining history of Sydney Hospital by Kappagoda1 illustrates the risk of accepting local lore as fact. The assertions that Sydney Hospital “hosted the first operation [in Australia] under general anaesthetic” and that it was “a leg amputation under chloroform” are both incorrect. The first surgical operations under general anaesthesia in Australia took place in Launceston, Tasmania, on Monday 7 June 1847, using ether administered with apparatus that had been depicted in the Illustrated London News.2,3 Two patients were successfully anaesthetised by Dr William Russ Pugh — both walked home and were completely happy with the procedure. The operation referred to by Kappagoda was reported in the Sydney Morning Herald (SMH) on Monday 28 June 1847 as having occurred “a few days back”4 — at least 2 weeks after Pugh’s patients were anaesthetised. Further, ether, not chloroform, was used in Sydney. The SMH reporter had also seen ether used to anaesthetise patients on other occasions, but these patients were undergoing dental extraction. The decision to operate may have been precipitated by a news item in the SMH on Thursday 24 June 1847. The paper reported that “The medical men at Launceston have made several successful experiments in performing surgical operations on patients who have inhaled ether.”5 To local readers, it would have been obvious that this had occurred at least several days, and possibly several weeks, before the Sydney surgery, because of the delay in transmitting news from Launceston to Sydney. Perhaps this news spurred the Sydney surgeons to act.

John D Paull

We’ll drink to that: the 200th anniversary of Australia’s oldest hospital

To the Editor: The first recorded use of an anaesthetic in Australia was not at Sydney Hospital, as stated by Kappagoda,1 but was at Dr John Belisario’s rooms in Spring Street, Sydney. Belisario, with Dr Charles Nathan (honorary surgeon to Sydney Infirmary), administered ether to two patients having dental extractions on 6 June 1847, and possibly to other patients a day or two earlier.2,3 The first recorded use of an anaesthetic for surgery was in Launceston, Tasmania, by Dr William Russ Pugh on 7 June 1847, when he administered ether for removal of an epulis from a woman’s jaw, followed by excision of a cataract from a man. Pugh published these cases in the Australian Medical Journal — the first medical journal in Australia, of which the Medical Journal of Australia is the direct descendant,4 and which only existed for 15 months. The Editor, Dr Isaac Aaron, was one of the first surgeons at Sydney Infirmary. Ether was the sole anaesthetic available in Australia for 10 months before chloroform was introduced. The first recorded death under ether occurred in Sydney on 9 April 1848. Two days later, on Tuesday 11 April, Nathan gave evidence in the morning at the inquest of this death and, in the afternoon, gave the first chloroform anaesthetic in Australia at Sydney Infirmary, to a young girl. The first recorded death under chloroform anaesthesia in Australia occurred on 19 July 1848 at Windsor, New South Wales.2 Sydney Infirmary, later Hospital, was closely involved in the early days of anaesthesia in Australia, both on site and through its staff, but cannot claim priority.

Michael G Cooper

What is wrong with Medicare?

To the Editor: In reply to my critics whose letters were published in the 20 February issue of the Journal1-4 after the publication of my article “What is wrong with Medicare?”,5 I would ask them to look broadly at Australia’s health care dollar and how it may be misspent. It is clear that the percentage of practitioners who wilfully set out to defraud Medicare, Veterans’ Affairs, workers compensation and other forms of insurance is relatively small. However, the current structure of Medicare, which is the result of poor policy decisions, allows inappropriate practice, as well as inefficiency and cost-shifting. Inertia in health care reform will continue to diminish our ability to deliver a first-world standard of care into the future. My critics would do well to consider this.

Tony D Webber

National guidelines for regulation of laser sales, training and use are urgently needed

To the Editor: Non-surgical cosmetic procedures have rapidly increased over the past 15 years, and although there are no reliable figures for Australia, there was an eightfold increase in such procedures in the United States between 1997 and 2010.1 Practitioners in the cosmetic field are seeing more frequent complications (eg, burns, scarring) from laser treatments that have been performed by untrained or inexperienced operators, including beauty therapists. These treatments are often performed as walk-in procedures in shopping centres. A cosmetic surgery report to the New South Wales Minister for Health in 1999 outlined a number of issues with laser use in Australia.2 More than 12 years later, very few of these issues have been addressed. There are more regulations on the sale and use of laser pointers in Australia than there are for lasers in health care. The Australian/New Zealand Standard 4173:2004, Guide to the safe use of lasers in health care, limits and classifies lasers used for medical purposes according to the degree of hazard. The Standard recognises that all personnel using and handling lasers should have training appropriate to the task they perform.3 Queensland, Western Australia and Tasmania have some regulations regarding medical grade lasers, but there are currently no regulations enforcing the Standard in other jurisdictions. There is also no industry standard for the necessary skills, qualifications and training for use of lasers, or regulation of these. National guidelines for the use of medical grade (Class 3B and 4) lasers need to be developed urgently and should address several issues to protect consumers: Medical grade lasers should only be sold to medical practices where the operator can be observed by a doctor at least some of the time, and complications can be discussed with the doctor. Medical practices should be licensed under the relevant Radiation Act in each jurisdiction (eg, Radiation Control Act 1990 in NSW) and listed on a website. All users of the laser in each licensed practice should be registered and individually licensed. National guidelines for accredited laser-safety courses should be established, ensuring adequate training and certification for obtaining a licence.

Charles Cope

Dermatology Letters 5 March 2012 Free

Stevens–Johnson syndrome after varicella vaccination

To the Editor: A 12-year-old boy presented to a regional emergency department with a 3-day history of progressing bilateral conjunctival injection, fevers (39°C), a widespread erythematous bullous rash, and superficial erosions to his lips, oral mucosa and urethral meatus. The patient was admitted to hospital for management of Stevens–Johnson syndrome (SJS). Initial treatment included intravenous f luids, intravenous ceftriaxone and oral azithromycin before transfer to a tertiary referral hospital. The patient had not taken any oral medications or over-the-counter therapies. He had no preceding viral symptoms. However, 2 weeks before onset of symptoms, he had received vaccination against varicella-zoster virus. On Day 1 of admission, intravenous immunoglobulin (Intragam P, CSL, Melbourne, VIC; batch numbers 3740600696, 3740500668, 3740600690, 3740600679) was administered at a dose of 1 mg/kg and repeated 20 hours later. On Day 2, oral prednisolone therapy (1 mg/kg/day) was initiated and continued for 5 days, and antibiotics were administered for 8 days (cefotaxime [50 mg/kg] and azithromycin [10 mg/kg]). Mycoplasma pneumoniae serological testing of blood samples taken on admission was negative. Bilateral conjunctival ulcers were managed with topical chloramphenicol eye ointment, topical 0.5% prednisone, lubricant drops and normal saline washes. The patient developed further areas of bullae and erosions to his cheeks and ears (Box). He also developed palmar papules, and dusky finger tips and toes. Skin bullous lesions were managed with daily sterile aspiration, and erosions were managed with silver-impregnated silicone dressings (Mepilex Ag, Mölnlycke Health Care, Gothenburg, Sweden). The patient’s rash and fevers abated, and he was discharged on Day 12 with advice from the dietitian and physiotherapy-assisted mobilisation. Sequelae at 2 months included cutaneous post-inflammatory hyperpigmentation. SJS after varicella infection has been reported,1,2 and a single case after varicella vaccination was included in a case series of six possible cases of SJS after vaccinations.3 SJS after medication use or infection with M. pneumoniae is well documented; however, cases where no clear cause can be documented result in increased parental anxiety. This case of SJS was preceded by varicella-zoster vaccination performed as part of school protocol. In the absence of any other obvious cause, it has been reported to alert practitioners of the possibility of a link (Therapeutic Goods Administration adverse drug reaction no. 291111). Patient with Stevens–Johnson syndrome after varicella vaccination

Elizabeth M Christou · Orli Wargon

Not much need for ambulatory blood pressure monitoring

To the Editor: Neal and Irwig1 argue that more precise measurement of blood pressure using ambulatory blood pressure monitoring is unlikely to deliver the clinical and economic benefits that could be achieved by switching to a risk-based strategy, such as that advocated by the National Vascular Disease Prevention Alliance.2 Moreover, they question: do you need to “know your numbers”? However, all risk-based strategies are based on numbers for blood pressure and various lipid parameters. Furthermore, despite a wealth of evidence that numbers-based approaches reduce cardiovascular events, I am not aware of any randomised controlled trial demonstrating the superiority, or even the equivalence, of a strategy based on 5-year absolute risk for cardiovascular prevention. Is a strategy based on 5-year absolute risk best for the individual patient? Clinicians treat lifetime risk,3 taking into account family history and, for women, the prospect of pregnancy. A low 5-year risk is not sufficient justification for withholding treatment of elevated lipids or blood pressure. Although the 44-year-old, male non-smoker without diabetes and with a systolic blood pressure of 170 mmHg may have a 5-year cardiovascular risk of 5%, clinicians will investigate and provide aggressive blood pressure treatment to reduce his lifetime risk. Treating according to the numbers will ensure that the choice of therapy offers the greatest risk reduction. Clinicians treat individuals, not populations. Management of the individual patient with cardiovascular risk is neither exclusively numbers-based nor exclusively risk-based, but a combination of the two approaches. We should use the approach that works best for the individual patient.

Duncan J Campbell

The future of fast-food regulation: new research suggests a novel strategy

To the Editor: The prevalence of obesity in Australia is increasing, with a quarter of Australians currently obese and two-thirds overweight.1 The fast-food industry is particularly implicated in this, because it offers cheap, high-calorie and low-nutrient food and employs branding that can alter taste preferences.2 Despite considerable lobbying from health groups, Australian governments have not elected to regulate the fast-food industry, instead leaving it to self-regulate. Predictably, a recent industry self-regulatory initiative aiming to decrease advertising to children failed.3 Suggested methods of regulating the fast-food industry have included taxing unhealthy foods, limiting advertising to children, and mandatory nutritional labelling. However, recent research has suggested a more creative solution. Instead of restricting the industry, perhaps the effective branding strategies of fast-food companies could be used for health promotion. It has been shown that children prefer food in McDonalds-branded wrapping over the identical item in plain wrapping.2 Even typically healthy items, like milk and carrots, are preferred when given McDonalds branding. New research has taken this idea a step further and shown that the branding of a fun, health-themed television show can be used to make healthy foods more appealing.4 These findings may motivate a new population-level strategy to reduce obesity. Established fast-food brands could be given incentives to apply their branding to healthy items. This would allow the fast-food industry to contribute to a healthier food environment, while avoiding the market restriction of taxation. Another option is to establish a government-funded enterprise that uses fast-food marketing to sell healthy items. Costs of such ventures may be outweighed by future reductions in health spending. With regard to obesity, perhaps it is time we started looking on the outside of the box for the solution.

Dugal B S Smith

Major haemorrhage in rural Australia: time for a novel solution to a unique problem?

To the Editor: The past decade has seen significant change in the management of major haemorrhage, including earlier and more aggressive use of fresh frozen plasma (FFP). Australian guidelines now advocate high ratios of FFP to packed red blood cells (PRBC) from the outset of resuscitation.1 Preparation of one unit of FFP for every two units of PRBC is recommended. This approach is supported by a recent meta-analysis demonstrating a reduction in organ failure and mortality with high FFP : PRBC ratios.2 In Australia, 40% of major trauma incidents originate in rural areas,3 some distance from tertiary or even secondary care. Initial resuscitation often falls to general practitioners (with no blood bank) or aeromedical services. In a 2010 international survey of 29 aeromedical services conducted by the Royal Flying Doctor Service (RFDS) (Western Operations), the seven responding Australian services reported difficulty accessing blood products. Only three had immediate access to PRBC, although all could obtain it within 45 minutes. None could obtain FFP without delaying departure, and only four had access within 45 minutes. This difficulty in obtaining blood products, particularly FFP, was evident in an analysis of major haemorrhage management by the RFDS (Western Operations). Of 7585 patients transferred in the 2009–10 financial year, 610 (8%) had a diagnosis that put them at risk of major haemorrhage; of these, 58 (9.5%) demonstrated physiological derangement predictive of requiring massive transfusion and did receive transfusion in flight. However, the FFP : PRBC ratios fell short of accepted standards (Box), particularly in patients originating from non-regional hospital locations. As logistical difficulties with storage and preparation render FFP impractical in remote Australia, alternative sources of coagulation factors must be explored. European groups have proposed replacing FFP with freeze-dried factor preparations (fibrinogen concentrate and prothrombin complex concentrate),4 which are currently available in Australia. These are easier to store, transport and deliver, and may be safer and more efficacious than FFP.4 Evidence that tranexamic acid significantly reduces mortality in trauma-related haemorrhage5 has been met with a guarded response in Australia. The study was conducted in developing countries with limited access to blood products and its applicability here has been questioned, although it may be highly applicable to remote and regional areas where FFP is scarce. Ongoing research and the planned Australian Massive Transfusion Registry will contribute further to the debate. When devising major haemorrhage strategies, however, it should be remembered that managing bleeding in Melbourne and managing bleeding in Meekatharra (in remote Western Australia) are two very different prospects. Ratio of fresh frozen plasma (FFP) to packed red blood cells (PRBC) in patients at risk of requiring massive transfusion, 2009–10 Origin of patient All patients (n = 58) Regional hospital (n = 35) Non-regional hospital (n = 23) Mean number of FFP units delivered: In referring hospital 0.9 1.3 0.3 During transport 0.2 0.3 0.1 Mean number of PRBC units delivered: In referring hospital 2.5 3.3 1.3 During transport 1.8 1.6 2.0 Overall FFP : PRBC ratio 1 : 3.9 1 : 3.1 1 : 8.3

Stuart A Gillon · Cem R Kibar

Letters 5 March 2012 Free

Evaluating workplace-based assessment of interns in a Queensland hospital: does the current instrument fit the purpose?

To the Editor: An evaluation of 3390 prevocational progress assessment forms in New South Wales suggested that the assessment instrument appears unable to detect underperforming doctors, and may not aid their professional development.1 Similarly, Queensland interns undertake five terms per year and, in each of these, they are assessed against 11 items in three domains: clinical competence, communication, and personal and professional skills. The purpose of the assessment is to identify underperformers and subsequently to help improve their performance. However, there is limited literature on the psychometric properties of the instruments used. Our study aimed to evaluate the construct validity and reliability of the instrument as a measure of interns’ performance. We performed principal component analysis (PCA) of the assessment items from all 72 interns who completed the five assessment forms during their intern year of the University of Queensland (2005 to 2007), working in one teaching hospital. A reliability test was performed using generalisability theory, which measured the variation in scores due to differences in performance between interns. It is generally expressed as a G coefficient ranging from 0 to 1 (no reliability to perfect reliability). Supervisors assess interns using the rating scale: “requires substantial assistance”; “requires further development”; “consistent with level of appointment”; “performance better than expected”; “performance exceptional”; or “not applicable or not observed”. Supervisors’ ratings were coded from 1 to 5 for the data analysis. Our examination of the assessment forms found that the mean of the skill items ranged from 3.69 to 4.16 (SD, 0.31–0.41). PCA identified only one factor from the 11 assessed items, and it explained 71% of variance in scores. The loadings of the coefficients ranged from 0.80 to 0.93 (Box) and the G coefficient was 0.16. These data show that the instrument in this setting only measures a single global work performance factor, has low reliability, does not discriminate well between interns, and does not differentiate well between the different domains and assessment items, raising the question as to whether it is fit for purpose. The assessment program should be able to assess all these required attributes of junior doctors as outlined in the Australian Curriculum Framework for Junior Doctors in order to work safely in Australian hospitals and other health care settings.2,3 Other assessment methods involving direct observation, such as the mini clinical evaluation exercise4 and direct observation of procedural skills,5 could be integrated into the assessment to enhance its validity, but would require trained assessors and substantial time commitment for development and delivery. Domains, assessed items, descriptive statistics and factor loading of principal component analysis of the assessment instrument used on 72 graduates Domain Skill items Mean (range) SD Factor loading Clinical skills Knowledge base: demonstrates adequate knowledge of basic and clinical science 3.72 (3.00–4.40) 0.33 0.84 Clinical skills: elicits and records accurate, complete history and clinical examination 3.87 (2.80–4.60) 0.37 0.90 Clinical judgement/decision-making skills: applies knowledge base and clinical findings; organising, synthesising and acting on information 3.88 (2.80–4.80) 0.39 0.90 Emergency skills: acts effectively and, when appropriate, acknowledges own limitations and seeks help 3.79 (3.15–4.40) 0.34 0.76 Procedural skills: performs procedures competently 3.70 (3.20–4.40) 0.38 0.72 Communication skills Patient and family: interacts effectively and sensitively with patients and families/caregivers 4.07 (3.40–4.80) 0.33 0.79 Medical records/clinical documentation: provides clear, comprehensive and accurate records 3.92 (2.80–4.60 0.41 0.88 Personal and professional skills Professional responsibility: demonstrates appropriate attitudes and behaviour, including punctuallity, reliability, honesty and self-care 4.15 (3.20–5.00) 0.34 0.85 Teaching: demonstrates commitment to learning, reflective thinking, and teaching others 3.69 (3.20–4.40) 0.34 0.80 Time management skills: organises and prioritises tasks to be undertaken 3.97 (3.20–4.60) 0.36 0.89 Teamwork and colleagues: works and communicates effectively within a team 4.16 (3.20–4.80) 0.31 0.93

Jianzhen Jenny Zhang · David Wilkinson · Malcolm H Parker · Andrew Leggett · Jill Thistlethwaite

Dog bites in Australian children

To the Editor: Kimble and colleagues have implied that the main strategic intervention to reduce the risk of dog bites is the education of dogs, owners and children, which is the equivalent of claiming that the most important way to prevent road accidents is for people to drive..

Katina D'Onise · Ronald L Somers

13 0

A case series of grevillea seed burns

To the Editor: Since the publication of Knight and colleagues’ case report on the topic, five more patients have presented with burns caused by Grevillea pyramidalis ssp. leucadendron, or maangga berry.1 Traditionally, these berries have been used by Aboriginal Australians for tattooing.1 As in the cases described by Knight and colleagues,1 these burns were sustained by Indigenous children aged 8–11 years in northern Western Australia and required specialist burn care. Two patients sustained 1.5% total body surface area, deep partial-thickness burns to their left forearms, which required surgical management. Three patients presented with superficial partial-thickness left forearm burns, which were managed non-operatively via telehealth. Four of the five patients were only referred to the state burns unit 7 days after the initial injury, and one patient was lost to follow-up. Management of these patients’ injuries was limited by compliance issues. Grevillea seeds can be responsible for deeper burns, which require surgical intervention, and superficial burns, which can be treated non-operatively. In this series, the burns occurred in Indigenous children with darker skin, which often has poorer scar outcomes. This demographic, coupled with compliance issues and late referral, make grevillea seed burns a difficult clinical entity to treat. Community education and health staff awareness is imperative in helping us provide optimal treatment in the future.

Joseph Luo · Tania McWilliams · Fiona Wood

Ethics Letters 5 March 2012 Free

Conflict of interest guidelines for clinical guidelines

To the Editor: We welcome the article by Williams and colleagues on conflicts of interest in clinical guidelines,1 and agree that such conflicts can undermine trust in guidelines, compromise patient care and skew health care spending. One challenge in managing conflicts is the lack of evidence that disclosure minimises their impact. For example, research at the United States Food and Drug Administration found that, despite disclosure, for every committee member with a conflict, there was a 10% greater likelihood of the meeting favouring the drug reviewed.2 Recusal (self-disqualification) is also problematic, especially in Australia where there may be a relatively small pool of experts available. Given these problems, we are concerned that some of the recommendations made by Williams and colleagues lack supporting evidence and fail to adequately address conflicts of interest. One of their recommendations, a tiered system within guideline panels limiting those with conflicts to contributions regarding the nature of the disease under discussion, for example, ignores what we know about the way that conflicts of interest operate. Research has shown that this apparently innocuous element of guideline development is not immune to influence, as conflicts of interest can influence how disease is defined, leading to broader disease definitions and lower treatment thresholds.3 A second recommendation was that guideline developers declare that “any benefits received have not influenced their professional opinion”. But surely this misses the real danger of such conflicts, which is not that of making deliberately biased decisions. Rather, the issue is that professional opinion may be unconsciously swayed by conflicts.4 Finally, they suggest an exclusion period of 3 years between receipt of industry support and involvement in guideline development. But no evidence is provided to ensure that this is “sufficient time for the conflict to have lost its potential for ‘undue influence’”. Without supporting evidence, the choice of 3 years, rather than 4 or 2 and a half, appears arbitrary. We need more research into the way conflicts of interest operate, and perhaps we need to seek a fresh pool of experts who, while less experienced, may be significantly less conflicted.

A Jane Johnson · Wendy A Rogers

Ethics Letters 5 March 2012 Free

Conflict of interest guidelines for clinical guidelines

In reply: We thank Johnson and Rogers for their letter. A tiered system has benefits but is not foolproof; vigilance by panels is needed to ensure disease definitions are appropriate. Delphi methodology, which can make participants anonymous via use of a facilitator, may prevent the influence of senior panel members over more junior ones in this and other regards. Although declarations would not affect conflicts operating at a subconscious level, turning one’s attention to conflicts at the time of recommendations may lead to greater awareness in some panelists. Declarations have almost no cost. We welcome more research into the length of time that “cures” conflicts. Including less experienced but less conflicted people on panels is a reasonable suggestion, though significant industry relations begin during trainee years, and expert input is likely to be beneficial for authority and take-up. Conflicts are a thorny issue, with undeniable tension between a purist approach and pragmatic considerations, particularly in a small pond. Given the present lack of transparency, we should urgently trial proposals supported by logic or evidence, and look forward to guidance from the National Health and Medical Research Council.

Michael J Williams · Dev A S Kevat · Bebe Loff

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