Article Types
Letters
Communication loads on clinical staff in the emergency department
To the Editor: I would like to compliment Coiera et al for their very interesting article about communication in an emergency department.1 Nearly a third of communication events were classified as interruptions, thus having an adverse effect on communication within the department. In trying to reduce this level of interruption, perhaps it is time to rethink the role of the on-call emergency physician in an emergency department. In most large Australian emergency departments, the emergency physician is also the admitting officer, who is responsible for coordinating the non-elective admissions of the day. This involves being readily available for external and internal phone calls, usually by mobile phone. Thus, as well as the normal clinical workload of an emergency physician, he or she needs to respond immediately to the summons of a mobile phone — a recipe for interruptions and less efficient communication. It is not optimal for the person who has clinical responsibility for the emergency department to also be the person through whom most of the communication is channelled. One possible solution is to channel calls about patients whom the referring doctor considers definitely need assessment in the emergency department to non-medical clerical staff. They could enter the details in a computerised "expected patients" database, which would be available for viewing by emergency department staff. Only calls about patients where there is some uncertainty, and advice calls, would be channelled to the emergency physician on call. This would facilitate both planning of the emergency department workload and also provide access to advice for the referring doctor. This change in process would reduce the number of phone calls received by the on-call emergency physician — and thus the number of interruptions — and improve overall communication within the emergency department.
Alan E O'Connor · Antony Nocera · Thomas Hamilton · Enrico W Coiera
Communication loads on clinical staff in the emergency department
To the Editor: Coiera et al1 should be congratulated for highlighting the excessive communication workloads of emergency department clinical staff, and the potential for these to be a source of errors and adverse events. However, their article fails to discuss the confounding variables, making it difficult to assess the validity of the communication strategies the authors propose to remedy the problem, or the applicability of their findings to other institutions. Emergency department overcrowding results from lack of access to hospital beds.2,3 Situations in which the number of patients exceeds the number of available beds (as depicted in the emergency department shown on the cover of the same issue of the Journal) are of particular concern, and would be expected to be a significant factor in the communication workload of clinical staff. Furthermore, many emergency departments do not have ward clerks, which means emergency department clinical staff perform the functions delegated to ward clerks in other hospital areas. The lack of direct telephone access to patients in the emergency department means that telephone calls from family members to a patient have to be directed through clinical staff. This increases the exchange of information between clinical staff, especially when the emergency department is overcrowded and patients are moved within the department to accommodate new patients. It is not clear, from the communication workload identified in Box 3,1 whether these factors were relevant in the institutions surveyed. In addition, Coiera et al do not indicate the seniority of the six doctors they studied. This is important given that the ratio of staff specialists to registrars or junior staff in emergency departments may be two to three times that of inpatient wards, increasing the number of times staff specialists communicate to junior medical staff in the emergency department. Finally, there is no mention of the adequacy of nursing staff numbers during the survey periods. If there were a lack of nurses, or if there were nurses on duty who normally do not work in the emergency department, one would expect an increase in communication between nurses. When emergency department infrastructure is so stressed, important studies, like that of Coiera et al, need to describe their findings in context, because of the likelihood of communication problems emerging as a result of health system failures.
Enrico W Coiera PhD, FACMI
Communication loads on clinical staff in the emergency department
To the Editor: I was interested in the report by Coiera et al1 about communication in the emergency department and the accompanying editorial by Vincent and Wears2 (from the United Kingdom and the United States, respectively, where, incidentally, the practice of emergency medicine differs significantly from that in Australia). In no other discipline is facility in communication between doctors, nurses, patients and relatives, as well as colleagues in other departments, of greater importance, given the paucity of information at presentation and the time constraints for assessment, management and appropriate referral — all within a time frame of a few minutes to several hours, depending on the severity of the presenting complaint. Vincent and Wears allude to the "fluidity and complexity of the clinical environment" and rightly suggest that studies need to be designed to embrace a "need to appreciate clinicians' decision making and cognitive load". It was therefore disappointing that, after so much effort, Coiera et al did not correlate their data with severity of clinical condition and/or outcome (eg, requiring resuscitation, assessment for possible admission, treatment solely in the emergency department, or discharge to outpatients clinic or home, to name but a few possible groupings). These may, of course, be intended for future publication. Regrettably, it is not stated how much input, if any, in the design and conduct of the study was obtained from staff in the unidentified emergency departments, and their contribution goes largely unacknowledged. As Richardson3 has pointed out, the active participation of at least one member of the emergency medicine staff (preferably senior and experienced) in such studies enhances motivation in staff busy with other priorities, and facilitates cooperation and collaboration (which can thereafter properly be recognised in co-authorship). There is also a danger that in the current litigious climate an inadvertent emphasis on "errors and poor outcomes" may prejudice the real benefits of the worthwhile objective of assessing the nature, relevance and value of improved communication between those engaged in clinical practice. Nonetheless, it is encouraging to deduce from this report that, in emergency departments, doctors and nurses regularly speak to each other, presumably with an optimal outcome for the patient in mind. For one who spent two decades as head of a busy, metropolitan emergency department, it is reassuring to find, in a discussion of informatics, advocacy2 for a return to the "white board", which, even today, remains the mainstay of patient information and tracking in many emergency departments.
Alan E O'Connor
Communication loads on clinical staff in the emergency department
In reply: We know little about communication systems in healthcare, and our study is still only one of a handful that quantify communication processes. Consequently, the aim of our pilot study, as well as reporting specific emergency department communication patterns, was to develop a robust general observational methodology, and measures of communication load.1 With the evidence that communication load is an issue, the next stage in the research would be to design studies to identify variables that could, in principle, affect communication load, as suggested by both Nocera and Hamilton. Indeed, there are many such variables — staff level and experience, organisational structure, clinical task, patient acuity, communication infrastructure, departmental policy, etc. The difficulty we will face is to control for many of these variables, and this will require longitudinal studies and samples from multiple sites. Hence, we are not yet able to make specific recommendations about interventions to "improve" communication in emergency departments. Indeed, there are no benchmarks against which to compare these data, so we cannot even say whether the data reflect good practice. Given these uncertainties, we agree with Nocera that it is too early to say which interventions would be appropriate to the specific circumstances of emergency departments, and we made no specific recommendations ourselves, but rather summarised commonly suggested interventions. Nocera and O'Connor also suggest other interventions which in their clinical experience may improve communication loads in emergency departments. It is likely that the variability of organisational settings will mean most such interventions will need to be customised to local conditions and needs. Hamilton is correct to highlight the tension in reporting data on organisational performance, and the risks of these data being misinterpreted or misused. Given these risks and the lack of comparative benchmarks, we explicitly chose not to comment on performance, nor to identify the organisations or participating clinicians. However, we would not have been able to carry out the study without the full cooperation of the staff at both hospitals, and, while they remain anonymous, we are deeply indebted to them for their willingness to welcome us into their workplace, volunteering to be subjects, and allowing us to observe them as they carried out their work.
Alan E O'Connor
Parasite elimination programs: home and away
To the Editor: The recent editorial by McCarthy and Garrow1 eloquently articulates a case for a coordinated national approach to controlling parasite infections in Aboriginal populations, based predominantly on the authors' experience with chemotherapeutic intervention in one remote community in Western Australia. While sympathetic to their motives, I am not so optimistic about the outcome of their proposal. For 20 years, Queensland maintained a centrally coordinated Aboriginal health program designed to monitor and eradicate parasitic infections. The program, which used targeted chemotherapy as its core strategy, was very successful with regard to intestinal worms, suppressing trichuriasis almost to extinction (unpublished observation) and virtually eradicating hookworm.2 However, the prevalence of gut protozoan infections (such as giardiasis and cryptosporidiosis) was hardly affected, for the obvious reason that these are relatively short-lived and spread directly person-to-person, which means that personal hygiene is much more crucial to their control. Systematic surveillance ceased after the program was dismantled (for political reasons) in 1990, and anecdotal reports since indicate that hookworm is now returning to Queensland. Again, this is not surprising given the mobility of Indigenous people, and the ability of infective larvae of Ancylostoma duodenale, the local hookworm species, to persist in a dormant state in host tissues, where they are refractory to currently available treatment.3 In support of their case, McCarthy and Garrow presented lymphatic filariasis in Australia as but one successful precedent, implying that it was eradicated "through sustained control programs conducted by dedicated public health agencies . . . using effective drugs".1 This is not supported by historical facts; the disease did disappear from endemic areas, but well before effective chemotherapy became available, and for reasons that are still debatable4 (although mosquito suppression, resulting more from general improvements in living conditions with rising community affluence than from any coordinated activity, is the most likely explanation). At the community level, parasitic infections of the gut represent not so much a primary problem as a symptom of a more fundamental societal malaise. They will disappear from Aboriginal communities only with a sustained improvement in living conditions (including nutrition, sanitation and personal hygiene), driven by the people themselves when armed with effective public health knowledge. This is a challenge that continues to dwarf the capabilities of all our governments and politicians, at all levels.
Paul Prociv · Stuart C Garrow · James S McCarthy
Parasite elimination programs: home and away
In reply: While specific details of control strategies for intestinal parasites vary according to parasite species, available anthelmintic agents and tools for environmental intervention, it is widely accepted that sustained, coordinated programs supported by government, community and health professionals with agreed methods and targets are the key to success.1 Prociv describes the outcome of just such a program for hookworm in Queensland, and the subsequent recrudescence of infection once the program was scrapped. The program in northern Western Australia succeeded because of commitment by government, community involvement entailing community debate and ownership of the program,2 education, and behavioural change, and improvement in public sanitation facilities as well as chemotherapy.3 We believe that a critical determinant of the outcome of our program was the inclusion of the community in designing the program. We agree with Prociv that control of filariasis and malaria was achieved in Australia by mosquito control; our statement about the role of sustained public health programs refers to the control of leprosy.4 With respect to the prospects for control of intestinal protozoa as well as helminths, a single-dose regimen with broad-spectrum activity would be ideal. While albendazole shows some useful clinical activity in giardiasis, single-dose regimens of this drug are insufficient to effect cure, as was observed in our study. While the social and environmental hurdles may appear to "dwarf the capabilities of government", we believe that there is a continuing need for Aboriginal health organisations, health professions and health departments at state and national levels to tackle parasitic infections. The logical approach is to model wider programs on successful local programs, and to avoid drifting into policy and program nihilism.
Stuart C Garrow · James S McCarthy
Use of the Internet by oncology patients: its effect on the doctor–patient relationship
To the Editor: The possible impact of the Internet revolution has been much discussed.1-3 In two surveys, conducted in 1999 and 2001, we surveyed oncology patients from two teaching hospitals in central Sydney to explore the experience and impact of Internet use among Australian oncology patients. In November 1999, a questionnaire was mailed to 240 eligible patients selected from 617 sequential registrations to the oncology units. Eligible patients were those who were alive, competent, had cancer, were of known address and whose attending medical officer was participating. In the second survey, to obtain a more representative sample, we invited all oncology patients visiting the outpatient clinics over a three-month period (September to December 2001) to participate. We received completed questionnaires from 142 patients (response rate, 59%) in 1999 and from 153 patients (number of refusals unknown) in 2001. Of these, 33% (47/142) in 1999 and 46% (70/153) in 2001 had accessed the Internet for information relating to their illness, either personally or through family and friends. In both surveys, most users accessed the Internet from home, the information sought was mainly in relation to treatment, and the most-visited Internet sites were those of cancer centres. Patient perceptions of the impact of Internet-acquired information on their experience of cancer are summarised in the Box. Most patients viewed its impact as positive. The advantages of using the Internet reported by patients included its speed, convenience, privacy, currency, diversity of viewpoints, and usefulness as a support tool. Many reported that they had sought corroboration of Internet information with information from other sources, especially their doctor. Problems identified with the Internet were its impersonal nature, time costs, overabundance of information, and concerns about the discovery of inappropriate, inaccurate or distressing information. Most respondents emphasised that they were able to recognise these limitations, but, notwithstanding, considered the Internet a valuable resource. For example, one respondent wrote: "I felt my capacity to cope with the illness and treatment greatly improved because I learned enough from the Internet to challenge my oncologist and thereby learn to trust him and his advice." Despite concerns expressed by many doctors, these oncology patients assessed impacts as either positive or neutral in overall influence. Increasing Internet use by patients and their families should not be viewed as a problem, but as an opportunity for patients and their treatment teams to work together, ensuring that patients have up-to-date information about their illness and its treatment and are aware that they are not alone in the fight against cancer. Perceived influence of Internet-acquired information among oncology patients in 1999 and 2001 Better No change Worse Question not answered 1999 survey (n = 47) Relationship with doctor 12 (26%) 30 (64%) 0 5 (11%) Discussions with doctor 20 (43%) 22 (47%) 0 5 (11%) Treatment decisions 22 (47%) 19 (40%) 1 (2%) 5 (11%) Coping with illness 26 (55%) 15 (32%) 1 (2%) 5 (11%) 2001 survey (n = 70) Relationship with doctor 24 (34%) 34 (49%) 2 (3%) 10 (14%) Discussions with doctor 42 (60%) 18 (26%) 1 (1%) 9 (13%) Treatment decisions 37 (53%) 25 (36%) 0 8 (11%) Coping with illness 32 (46%) 31 (44%) 1 (1%) 6 (9%)
Julia ML Brotherton · Stephen J Clarke · Susan Quine
Acute community-acquired meningitis and encephalitis
To the Editor: The article on acute community-acquired meningitis and encephalitis by Beaman and Wesselingh1 provides a comprehensive and up-to-date review of diagnostic and management issues relevant to general clinicians. However, the section on vaccines for preventing meningococcal C and pneumococcal diseases is not as contemporary. Contrary to the authors' statements that "a conjugate vaccine covering serogroup C [meningococcus] will be available in Australia shortly", and "a conjugate vaccine [for pneumococcus] is currently under trial in Australia", conjugate vaccines for both diseases are available and registered for use in Australia. Conjugate vaccines have the advantage that they can be used in children from six weeks of age and are expected to provide long-term protection. Meningitec is a meningococcal group C conjugate vaccine approved for use in children from six weeks of age, adolescents and adults. Meningitec has been available from Wyeth Australia since October 2001, but is not part of the National Childhood Immunisation Scheme and, as such, can only be obtained on private prescription at present. Prevenar (pneumococcal septavalent conjugate vaccine) is also approved for use and has been available from Wyeth Australia since January 2001. Prevenar is indicated for active immunisation of infants and children from six weeks to nine years of age against invasive disease, pneumonia and otitis media caused by Streptococcus pneumoniae.
Deborah C Saltman · Miles H Beaman · Steven L Wesselingh
Acute community-acquired meningitis and encephalitis
In reply: We thank Saltman for up-to-date information on Wyeth vaccines. Readers will appreciate that our article1 was commissioned in January 2001, and the manuscript delivered in August that year, before the licensing of Meningitec. As the article discussed, group C meningococcus is a minority strain in most regions of Australia. Hence, the vaccine will not prevent most cases of what is already an uncommon disease. Conjugate pneumococcal vaccines should have much wider application in the future, but currently are subsidised for use in only a minority of the at-risk population.
Deborah C Saltman MD, FRACGP, FAFPHM · Miles H Beaman FRACP, FRCPA · Steven L Wesselingh FRACP, PhD
Short-term effectiveness of bupropion for assisting smoking cessation in general practice
To the Editor: As noted in the letter by Chapman and Jamrozik,1 there was substantial prescribing of bupropion sustained release (Zyban SR; GlaxoSmithKline) following its Pharmaceutical Benefits Scheme (PBS) listing from 1 February 2001. The drug has been the subject of extensive publicity following reports of adverse drug reactions and deaths of patients while taking bupropion. Although bupropion has been shown to be effective in two key clinical trials,2,3 there are no studies of effectiveness when prescribed in the context of Australian general practice. We conducted a study of short-term effectiveness involving 11 general practice registrars working in eight practices in south-west and southern Sydney. Each registrar identified from practice prescribing records 10–15 patients prescribed bupropion after 1 February 2001. These patients were followed up via a telephone questionnaire 10 weeks after the date of prescription. The questionnaire elicited information on the use of bupropion, patient-reported abstinence rates, adverse effects and use of support services. Biochemical validation of smoking status was not conducted. Interviews with 151 patients were conducted between April and August 2001 (see Box). Patients completing seven weeks or more of therapy were significantly more likely to report both continuous abstinence (P = 0.01) and point-prevalence abstinence (P = 0.002). Eighty-three patients reported adverse effects, the five most common being insomnia (14%), headaches (11%), nausea (8%), dry mouth (5%) and irritability (4%). No convulsions were reported. Patients who made use of one or more support services for cessation counselling were no more likely to report point-prevalence abstinence at follow-up than those who did not (P = 0.8). Our study was not based on a random sample of GPs or patients, and we did not collect data on the total number of patients treated with bupropion in these practices over the study period. Bearing in mind these limitations, the study has a number of notable findings. Despite the wording of the PBS authority "for use within a comprehensive treatment program'', fewer than half the patients reported using any support service. There was also a low rate of completion of the recommended course of treatment (less than 20% of patients). While the short-term abstinence rates among the patients followed up were encouraging, and not dissimilar to rates found in clinical trials,2,3 there is clearly a need to look at strategies to encourage patients to adhere to the prescribed course of treatment and to make use of cessation support services. We suggest patients be invited back for at least two follow-up GP visits following prescribing of bupropion, as well as being made aware of other support services. Ten-week follow-up survey of patients prescribed bupropion sustained release (Zyban SR) for smoking cessation (n = 151) Patients taking all or part of course of drug therapy 124 (82%) Mean duration of therapy (weeks) 4.6 (range, 1–12) Patients completing at least seven weeks of therapy 24 (19% of those who took all or part of course) Patients reporting continuous abstinence at 10 weeks 47 (31%) Patients reporting point-prevalence abstinence at 10 weeks 57 (38%) Patients reporting adverse effects 83 (68% of those who took all or part of course) Patients accessing one or more support services (general practitioner, Quitline, ZAP*) 69 (46%) *ZAP = Zyban Action Plan (trademark of GlaxoSmithKline)
Nicholas A Zwar · Alia Nasser · Elizabeth J Comino · Robyn L Richmond
Surgeons' views about colorectal cancer screening before and after national guidelines
To the Editor: In November 1999, the National Health and Medical Research Council (NHMRC) released Guidelines for the prevention, early detection and management of colorectal cancer.1 One chapter addressed screening for colorectal cancer (CRC), citing Level 1 evidence in support of faecal occult blood testing (FOBT) as the preferred modality for population-based CRC screening. Colonoscopy and sigmoidoscopy were not recommended. In a postal survey conducted in 1998, before release of these guidelines, we found mixed views among Australian surgeons about CRC screening.2 In February 2001, we conducted a follow-up (post-guidelines) survey which included three questions about CRC screening that had been asked in the pre-guidelines survey. Using a pre–post design, we evaluated the impact of the NHMRC guidelines on surgeons' views. Of the 172 surgeons confirmed still to be in active practice at the time of follow-up, 114 (66%) returned questionnaires. One hundred and three (90%) agreed to matching of their baseline and follow-up responses. Of these, 101 (98%) provided valid responses to each of the three questions on both occasions. Surgeons' views about population-based CRC screening by FOBT changed significantly between the surveys (Box). At baseline, half "strongly agreed" or "agreed" that population-based FOBT should be introduced for all Australians over the age of 50 years. At follow-up, the proportion had increased significantly to more than two-thirds (McNemar's χ2 = 13.0; P < 0.001). There was no significant change in the percentage of surgeons who "strongly agreed" or "agreed" that colonoscopy is preferable to FOBT (McNemar's χ2 = 0.9; P = 0.3). In contrast, there was a significant decrease in the percentage who "strongly agreed" or "agreed" that sigmoidoscopy is preferable to FOBT (McNemar's χ2 = 4.4; P = 0.04). Although the influence of events unrelated to the NHMRC guidelines cannot be entirely excluded from uncontrolled evaluation designs such as this, our data provide some reassurance that the guidelines have had an impact. However, as argued elsewhere,3 substantially more effort is required to ensure that patients with CRC detected through screening receive evidence-based management. More rigorous study designs with control groups are recommended to identify strategies effective in changing surgical practice. Finally, surgeons' increased enthusiasm for CRC screening contrasts with public hesitancy.4 Surgeons' views about screening for colorectal cancer before and after publication of national guidelines1 (n = 101) Strongly agree Agree Neutral Disagree Strongly disagree Population-based screening by FOBT should be introduced for all Australians over 50 years of age Before After 17% 26% 34% 44% 28% 23% 18% 8% 4% 0 Colonoscopy is preferable to FOBT as a population-based screening method Before After 6% 7% 23% 28% 21% 22% 42% 37% 9% 7% Sigmoidoscopy is preferable to FOBT as a population-based screening method Before After 2% 1% 23% 13% 13% 23% 55% 55% 8% 9% FOBT = faecal occult blood testing. Due to rounding, row percentages do not necessarily sum to 100%.
Annie Cooney · Neil J Donnelly · Melina Gattellari · Jeanette E Ward
Low rate of compliance with ergocalciferol therapy in vitamin-D-deficient patients with hip fracture
To the editor: Large randomised trials have confirmed that treatment with cholecalciferol (vitamin D3) and calcium reduces hip and non-vertebral fractures.1,2 In public health terms, calciferol compounds are cost-effective,3 simple to monitor and generally free of side effects. Ergocalciferol (vitamin D2) is the only single prohormonal form of vitamin D available in Australia.4 As compliance rates for this medication have not, to our knowledge, been evaluated, we decided to conduct our own study of compliance. At the Royal Perth Hospital, between June and September 2001, we identified 106 people with hip fracture who were vitamin D insufficient (defined as a serum 25-hydroxyvitamin D level < 50 nmol/L) and began treatment with ergocalciferol. Three months after discharge, we interviewed patients to determine whether they were complying with treatment and, if not, the reasons for non-compliance. Of the 106 patients identified, 53 were interviewed (the remaining 53 patients were not contacted for various reasons: 38 did not live in the metropolitan region, eight had died, one refused interview and six were lost to follow-up). Of the patients interviewed, 33 (62%) had complied with therapy. Reasons for non-compliance among the remaining 20 (38%) are outlined in the Box. Reasons for non-compliance with vitamin D therapy Reason Number of patients Not on discharge script from orthopaedic ward/ Reason for taking medication unknown by patient and/or carer 9 Stopped by general practitioner or doctor from another hospital/ Not continued after hospital supply used up 6 Patient refusing all medication/ Patient moribund 4 Side effects/ Intolerance of medication 1 The most common reason for non-compliance was poor communication between the hospital and the general practitioner. The second most common cause of non-compliance — failure to continue treatment on discharge or active cessation by the attending physician following discharge — indicates either that medical practitioners are ambivalent about the treatment of vitamin D deficiency or that patient-specific factors are at work. Ergocalciferol is not listed under the Pharmaceutical Benefits Scheme. It is available directly from pharmacy outlets without a prescription and the cost of treatment (currently about $17.50/month for 60 × 1000 IU tablets) must be borne entirely by the patient. Thus, continuation of treatment is largely dependent on patient initiative, and, in our survey, cost may have been a disincentive to continue the medication once the hospital discharge supply was depleted. Side effects of the medication were a very minor reason for non-compliance — only one patient out of 20 stopped therapy because of ergocalciferol intolerance. Our audit had several limitations: the sample size was small, treatment was not blinded, and only patients living within the inner Perth metropolitan area were interviewed, which may have introduced bias. Vitamin D deficiency remains a common and undertreated cause of osteoporotic hip fracture in elderly people, both in Australia and elsewhere.5 Our study suggests that the rate of non-compliance with ergocalciferol therapy is unacceptably high.
Jane M Noble · Marjory McGuiness · Paul Glendenning
Should radiologists and pathologists talk to patients?
To the Editor: The practice of radiology and pathology has changed dramatically in the past two decades. Increased use of multidisciplinary assessments and interventional techniques has meant greater exposure of patients to radiologists and pathologists. When patients undergo investigations, they are invariably anxious, usually expect the worst, and want the result as soon as possible. Therefore, there is pressure to provide an immediate answer to the problem at hand. In most instances, it would be possible to offer a diagnosis. However, many radiologists and pathologists are reluctant to discuss investigations with patients in detail.1 During interventional procedures, radiologists and pathologists see patients only briefly; they often don't know all the facts about them, and are not ultimately responsible for their clinical management.1 As the patient is only temporarily in the care of the radiologist or the pathologist, it is not appropriate to discuss complex issues or offer opinions and advice. Such advice may put the patient's doctor in an awkward position, forcing the referring practitioner to follow a course of action which may not be in the best interests of the patient. At a patient's insistence, radiologists and pathologists can sometimes indicate to someone who has a clearly benign condition that the problem under investigation is unlikely to be serious.2-4 This may be the case with screening mammography, as, in most cases, the results are either normal or indicate a non-malignant condition. However, in diagnostic radiology and pathology, such an opinion is usually based on a preliminary impression, which may change when all the facts are considered. The cost of providing on-the-spot written reports to the patient has to be factored into the equation. It has been estimated that the additional cost of immediate reporting of results of screening mammography is about US$28.22. When additional equipment and space were not required, the cost would increase by US$4.38. Although most patients in the study preferred immediate reporting, they were unwilling to pay the additional fees.5 With respect to pathology, a formal fine-needle aspiration result can be delivered within an hour, but, for the reasons outlined above, this would not be advisable. Further, the pathologist's contract is with the referring doctor and the report is written in scientific language, which may not be easily understood by the patient, leading to unnecessary anxiety. Giving bad news to a patient is not an easy task even for trained professionals. It is even harder for radiologists and pathologists who are not generally equipped to provide counselling and support, and who may not be indemnified by their insurers to carry out such tasks. Further, neither radiology departments nor pathology laboratories are suitable settings for giving bad news,1 as very few support avenues are usually available to patients there. Predicting the impact that bad news will have on a patient is extremely difficult, and radiologists and pathologists should, for compassionate and for medicolegal reasons, refrain from providing immediate answers to patients.
Ibrahim M Zardawi
The demise of a planned randomised controlled trial in an urban Aboriginal medical service
To the Editor: Jamrozik's editorial1 about our report of a failed randomised controlled trial (RCT)2 in an Aboriginal medical service helps to explain why researchers might be reluctant to submit articles describing unsuccessful trials, thus limiting potential for the scientific community to learn from such experiences. The main point of our article was to describe the manifest difficulties of implementing an RCT — the evidence "gold standard" — in this type of setting. Interestingly, Jamrozik largely attributes these difficulties to incompetence or naivety (or both) on the part of the researchers and funders, rather than to complexities inherent in the study design, the setting and the intervention. A separately funded pilot study is, in principle, a good idea, but extremely difficult to get funding for in today's environment. Of course, we did conduct a pilot — that, in fact, was what we reported on — but it is unclear how this would have helped us better estimate absolute prevalences and effect sizes for intervention and control groups, as a substantial number of participants, followed up for six months, would have been needed to do this. Nor is it clear how taking a population approach and distributing guidelines to all drinkers rather than offering personalised advice to hazardous drinkers would have helped — firstly, because we were specifically trialling the internationally validated brief intervention, and secondly, because the effect size of the alternative approach would have been so small that we would have needed very much larger numbers to test its effectiveness. We had no intention of "stumbling down something like this path". Nor do we agree that the blood tests were "medicalising a social problem". They were intended not only to provide robust outcome measures (a mark of a good trial), but also tangible evidence to clients of the health effects of alcohol, shown from previous research to be well received by Aboriginal people.3,4 They were not a requirement for participation. Further, that we should have got around the potentially off-putting business of seeking informed consent by bypassing this step almost defies comment. While trials of some therapeutic interventions can be undertaken blind with patient consent by using placebos, this does not mean that where blinding is not possible patient consent should be done away with in order to avoid a Hawthorne effect! However, we do agree with Jamrozik on one point — nothing about this study or our report could reasonably "compound any negative perceptions about Aboriginal Medical Services and Aboriginal patients".1
Beverly M Sibthorpe · Ross S Bailie · Maggie A Brady · Sandra A Ball · Polly Sumner-Dodd · Wayne D Hall · Alan Pettigrew · Tom Gavranic
The demise of a planned randomised controlled trial in an urban Aboriginal medical service
To the Editor: I am responding to a recent editorial by Jamrozik1 commenting on a study proposed by Sibthorpe and colleagues to assess a brief intervention for hazardous use of alcohol by Indigenous people in an urban setting.2 After two unsuccessful attempts to recruit participants, the study was discontinued and funds returned to the National Health and Medical Research Council (NHMRC) in 1998. Sibthorpe et al identified their difficulties as primarily the result of having overestimated the number of suitable participants, for a number of complex reasons. Jamrozik's criticisms rest disproportionately with the NHMRC and are based on procedures and processes in effect in 1996 and 1997, yet they are informed by contemporary knowledge and wisdom. This seems somewhat anomalous. In 2000, the NHMRC revised its system for assessing research applications. This involved several developments which would have had a direct impact on the assessment of this application had they been instituted in 1996. Some of these include: the introduction of panels comprising 11 experts in the domain of the application; the introduction of the Indigenous Health Research Panel (IHRP), which provides advice on cultural appropriateness, community consultation and methods in applications with an Indigenous component (most members are Indigenous people); and the opportunity for IHRP to make stipulations upon which funding is contingent. Also of significance was the establishment of the Research Agenda Working Group (RAWG), which oversaw the formulation of intervention-based criteria. Colloquially known as the "Darwin criteria", these principles ensure that all Indigenous research design has: sufficient Indigenous community consultation and participation; transferability (of the methods to other settings); and sustainability (of resulting changes). The NHMRC was disappointed that the study by Sibthorpe et al did not proceed and did not result in usable data to inform a significant problem. However, it is also important to recognise that unanticipated outcomes, which can often lead to other, very positive results, are an integral part of the learning process. The NHMRC has supported Australian health and medical research since 1936. It has a strong commitment to ensuring the continuing evolution of its procedures and practices. The new systems implemented in 2000 were designed to ensure the continuing tradition of funding high quality, relevant and applicable research.
Beverly M Sibthorpe BA(Hons), PhD · Ross S Bailie MD, FAFPHM · Maggie A Brady MA, PhD · Sandra A Ball BCom, GradDip Public Administration · Polly Sumner-Dodd DipManagement · Wayne D Hall BSc, PhD · Alan Pettigrew BSc, PhD · Tom Gavranic MB BS, DPH, FRACGP
Postoperative serious adverse events in a teaching hospital
To the Editor: The article by Bellomo et al,1 with its alarmist conclusions, received a lot of media attention. However, the authors' methodology is flawed and their conclusions are unsupported by their data. They describe postoperative adverse events in a group of largely elderly patients (median age, 65.5 years) who stayed in hospital more than 48 hours after inpatient surgery. These selective criteria were used "to exclude patients having day surgery or minor procedures". Stratifying the severity of operations according to duration of stay is fundamentally flawed. This would have excluded many major, short-stay operations if the patient had had an uneventful postoperative course (eg, laparoscopic cholecystectomy and complex endoscopic procedures), and included others simply because a complication prolonged the patient's stay. The result is a selective bias towards a high complication rate. A more valid approach would have been to stratify all inpatient operations by severity and to include all major operations in the denominator for the study. This strategy would undoubtedly have shown significantly lower complication and mortality rates than those reported by Bellomo et al. The "silent epidemic" referred to in the study is neither silent nor an epidemic. An epidemic refers to a disease normally absent but liable to outbreaks. What the authors describe is an endemic situation (habitually present, of common occurrence); it is quite obvious and already extensively documented. Elderly patients undergoing major operations (especially in an emergency — "unscheduled surgery" in the authors' pejorative lexicon) are likely to have complications, and, when they do, need to stay in hospital longer. The authors did not analyse whether the adverse events were preventable, and therefore they cannot justify their conclusion that "there is much scope for improving postoperative care".
Thomas B Hugh · G Douglas Tracy · Rinaldo Bellomo · Donna Goldsmith · Sarah Russell · Shigehiko Uchino
The demise of a planned randomised controlled trial in an urban Aboriginal medical service
To the Editor: The recent article by Sibthorpe et al1 and the accompanying editorial2 on the issue of the failure of an alcohol intervention trial in an Aboriginal Health Service deal with problems facing all primary care practitioners in the field of "alcohol misuse" and should not be seen as a peculiarly Aboriginal problem. Firstly, despite what the academics may tell us, administering an Alcohol Use Disorders Identification Test (AUDIT) questionnaire in general practice as a screening measure meets with huge resistance, no matter where you practice. Denial of the disease-inducing potential of alcohol is certainly not peculiar to Aboriginal society. Secondly, I find that the bulk of the medical profession reinforces this community denial by diagnosing conditions such as diabetes, hypertension, obesity, anxiety, depression and schizophrenia instead of seeing these problems as being a manifestation of alcoholism or other "alcohol misuse" until proven otherwise. Indeed, the denial is so extreme that they tend to avoid the term "alcoholism" altogether. Specialists are in even greater denial and are more often a hindrance than a help to general practitioners in this regard. As a consequence, community leaders and affected families are unable to develop effective strategies for dealing with their problems. What they get instead is increasing healthcare costs, hospital bed shortages, increasing domestic violence, more "drug problems" and more prisons. So "GP reluctance or inability to follow through . . ."2 is not surprising. Indeed, denial of alcohol is so strong in the medical profession that it is harder, in my experience, to get doctors and even medical students (let alone healthcare workers) to attend open meetings of Alcholics Anonymous and Al-Anon than it is to persuade affected people to do so. Thirdly, general practice throughout Australia has been organised for episodic, fast-throughput care. People have become so accustomed to this that they see any attempt at a comprehensive preventive approach to illness as odd, out of place, time-consuming and even intrusive, especially so where alcohol and family histories are concerned. That Aboriginal people are no different from the rest of us in this regard should cause no surprise.
Beverly M Sibthorpe · Ross S Bailie · Maggie A Brady · Sandra A Ball · Polly Sumner-Dodd · Wayne D Hall
Postoperative serious adverse events in a teaching hospital
To the Editor: The information in the article by Bellomo et al,1 which documents postoperative serious adverse events in a teaching hospital, contains no surprises; nor does it support some of the authors' conclusions. In 1995, the findings of the Quality in Australian Health Care Study2 were immediately sensationalised by the press with the headline "Hospital errors kill 18 000 a year".3 The article by Bellomo and colleagues provoked similar predictable media sensation. As acknowledged by the authors, the study addressed neither the causes of the serious adverse events, nor whether they were "preventable". Furthermore, the authors fail to show how their findings "suggest that there is much scope for improving perioperative care in our tertiary hospitals", or why "this is a 'silent' epidemic which requires urgent and systematic attention". However, in televised interviews, they made no effort to reduce the alarm aexpressed at the prevalence of errors. They have invented a new designation of "unscheduled surgery" (which presumably refers to acute, urgent or emergency admissions), preferring a title that suggests an avoidable lack of scheduling. It is hardly surprising that this group of patients required most of the admissions to the intensive care unit for which no prior booking had been made. It is unclear why the authors mention that "six of nine patients over 92 years of age having hip surgery died". Again, one presumes that these operations were for hip fracture, a condition with 100% mortality if untreated. And why leave out patients aged between 90 and 92 years? No amount of statistical manipulation conceals the bias that is obvious in their article. It might provide a media story, but it has minimal value for the critical reader.
Thomas B Hugh FRCS, FRACS · G Douglas Tracy · Rinaldo Bellomo MD, FRACP · Donna Goldsmith RN · Sarah Russell RN, PhD · Shigehiko Uchino MD
EBM in action
To the Editor: I read with interest the recent correspondence in the Journal from Del Mar and Glasziou.1 Their appeal to one of their critics was to "abandon throwing bricks from the sidelines and join us in trying to help clinicians assess research evidence in [a] timely fashion". More recently, their defence in relying on generalists, rather than experts, to assess the evidence was, somewhat curiously, that "a cat may look at a king".2 In response to these comments, I believe that one of their recent presentations relating to natural remedies for osteoporosis in postmenopausal women3 falls short of current evidence-based medicine requirements. I suspect that this may be because they have no expert in the area they are reviewing to assist them in assessing the data. An expert would have been able to tell them that their statement "Although no trials specifically compared 'just walking' with 'exercise in the gym', there was reasonable evidence supporting the beneficial role of walking in this patient group"3 was incorrect.4 Furthermore, an expert would have known that the fundamental biological basis of the effect of exercise on the skeleton relates to the induction of significant strains within the skeleton.5 Because these effects are site-specific and load-dependent, the physiological mechanisms differ from those involved in cardiovascular health. Secondly, an expert in the area may have pointed out that the principal constituent of codliver oil that affects the skeleton is vitamin D. To claim that there were no benefits on bone mineral density or fracture from vitamin D would not be supported by current data.6 Keeping up-to-date in medical practice has become more difficult as the information base expands. Performing an Internet search may be adequate for answering some patient-based specific questions, but, in general, reading an up-to-date review is probably better. Presenting the results of a rapidly performed, deficient analysis in an internationally renowned journal is another thing entirely.
Richard L Prince · Christopher B Del Mar · Paul P Glasziou
Postoperative serious adverse events in a teaching hospital
In reply: We thank Tracy and Hugh for the issues they raise. The goal of our study was to establish baseline information on the incidence of serious adverse events (SAEs) for use in subsequent intervention studies.1 The data were needed for statistical power calculations. Our inclusion criteria were predefined, as is scientifically orthodox for any study. We chose to study a population of clinical relevance to inpatient medicine. Most simple procedures at our hospital require day admission with no overnight inpatient stay, so these were not relevant to our goals. Others may wish to study different patient populations and are free to do so. In our opinion, there was no particular bias in our study, just accurate, prospective documentation of events. We used the term "unscheduled surgery" because it is verifiable and objective. An operational definition is necessary; otherwise, judgements about what is a true emergency (like judgements about what is preventable) are very dependent on observer bias. Nonetheless, according to our judgement, only 48 of 426 "unscheduled" operations were true emergencies. We wanted to identify groups that were at particular risk of death, hence the mention of patients over 92 years of age who had had hip surgery. Up to what level of expected postoperative mortality does it remain acceptable to perform major surgery in very elderly patients? We stand by our opinion that we are dealing with a silent epidemic. It is silent because we could find no previous prospective studies of SAEs for all major operations published (in English) in the medical literature, and there was no systematic plan to tackle them. We use the term epidemic because (in the absence of objective documentation of rates of SAEs in the past) our impression is that this is a growing phenomenon, related to the increased use of major surgery in the elderly. We also consider that only the absence of SAEs would offer no scope for improvement. A rate of SAEs of 16.9% should, logically, offer much scope for improvement. Whether such improvement can be realised remains a matter for future interventional investigations.
Thomas B Hugh
EBM in action
In reply: We agree with Prince that expertise is needed. The only question is, expertise in what? If we rely on experts in the content area, we are subject to error from ignoring studies that do not fit the expert's view or from an overemphasis on studies familiar to the expert.1 On the other hand, if we rely on experts in systematic reviews, we are likely make other errors, especially errors of omission, because we do not know the content area so well. Perhaps what we need is a marrying of the two. First, experts should learn the business of evidence-based medicine (EBM). It should be part of the training of specialists and general practitioners, as well as medical students. In addition, the Australasian Cochrane Centre runs Australia-wide courses in preparing and interpreting systematic reviews.2 Second, we should find a content expert to assist any review being undertaken (and, indeed, we try to do this when writing systematic Cochrane reviews). But when we need to respond rapidly to clinicians' and our own questions, there is not time to consult experts for each one. (The doctor in question3 asked five rather separate questions, of which Prince addresses only two.) Instead, we try to do exactly what Prince has suggested: we first look for an up-to-date review (a systematic review, to avoid bias),1 and, in the absence of one of those, proceed with weaker levels of evidence progressively down a cascade. And that is exactly what we did in this case.3 The purpose of our rapid search service is to provide, as quickly as possible, the best available evidence to assist a doctor help a patient — "EBM in action". The five meta-analyses we identified3 did not include your references. We do not, and do not claim to, offer the last word in a very complicated area of clinical practice.
Richard L Prince MB BS FRACP MD · Christopher B Del Mar MD FRACGP FAFPHM · Paul P Glasziou MB BS PhD
eMJA: In other journals - 19 August 2002
Buzz off! With summer fast approaching and the spectre of evening barbecues dogged by mosquitoes, it is interesting to note that a recent US study confirms that personal repellents containing N,N-diethyl-3-methylbenzamide (DEET) are still the best available in that country. Fifteen volunteers tested 16 products three times each (a total of 720 tests) using the “arm-in-cage” technique. DEET-based products provided complete protection for 88.4 to 301.5 minutes, depending on their concentration. Citronella-based products protected for 2.8 minutes (0.5%) to 18.9 minutes (10%, combined with other botanical oils) and a 2% soybean oil product (marketed for children) protected for 94.6 minutes. Wrist bands impregnated with either DEET or citronella were completely ineffective. For those of you who swear by a popular bath oil, this failed the test after 9.6 minutes. Interestingly, a product containing eucalyptus oil came onto the US market just as the study finished. Testing on six subjects ended in a skin reaction in one and a mean complete protection time of 120 minutes in the other five. N Engl J Med 2002; 347: 13-18 ... A thousand words Recent articles in the MJA highlighting a lack of psychosocial outcome data for cosmetic surgery did not include children, but a report from a US plastic surgeon suggests that we can learn much about children’s response to such surgery from their art. The surgeon collected 200 drawings from children, before and after they underwent surgery for a variety of congenital, aesthetic and traumatic deformities. A child psychiatrist and an art therapist evaluated the drawings, finding recurring themes of low self-esteem, isolation, unhappiness and fear in the “before” drawings, with improvements in all these parameters in the “after” drawings. Twelve examples are reproduced in the printed article, which is well worth a look. Plast Reconstr Surg 2002; 109: 1777-1786 Making the news In Other Journals image At the MJA we often wonder why some of our articles capture the imagination of the popular press, while others are met with a deafening silence. A study of press releases by medical journals and medical reporting in two British newspapers suggests that bias operates at both levels. Of 1193 original research articles published in the Lancet and BMJ in 1999 and 2000, 517 received a press release and 81 were reported in either the Times or the Sun newspapers. No studies without press releases made it into the papers, but newspapers were more likely to follow-up press releases reporting “bad” than “good” news, and preferred observational studies to randomised controlled trials. The hot topics were women’s health, reproduction and cancer. BMJ 2002; 325: 81-84 Don’t worry, be happy! Expectant mothers have yet another thing to worry about, as new research reveals that anxiety in pregnancy is associated with behavioural and emotional problems in their offspring. The Avon Longitudinal Study of Parents and Children followed 7448 women in Avon, UK, from early pregnancy until their children were four years old. Maternal anxiety and depression were measured via validated self-report instruments at 18 and 32 weeks’ gestation, and four times in the three years following birth. The children’s behavioural adjustment at age four was estimated by a validated parental report measure. High antenatal maternal anxiety scores in late pregnancy were associated with behavioural and emotional problems in both boys and girls (ORs 1.56 and 1.51, respectively, after controlling for antenatal, obstetric and psychosocial factors, and postnatal depression and anxiety). Br J Psychiatry 2002; 180: 502-508 A burning issue With the annual incidence of melanoma currently in excess of 45/100 000 for men and 35/100 000 for women, Australia remains the melanoma mecca of the world. Public health messages about sun exposure are starting to show benefit, however, with a recent slight fall in incidence in younger women. The same is not true for Scotland, a country better known for its bleak weather than its opportunities for sunbathing. The Scottish Melanoma Group collated data on the 8830 patients diagnosed with invasive melanoma in Scotland between 1979 and 1998. The incidence increased steadily during the study period (from 3.5 to 10.6/100 000 in men, and 7.0 to 13.1/100 000 in women). Five-year survival rates improved, however, due to a higher proportion of thinner detected tumours in later years, suggesting that the Scots are at least responding to secondary prevention messages. Lancet Volume 360 Issue 9328 Page 23 Published online June 25 2002-07-19
Thalidomide and cancer
To the Editor: Thalidomide (N-α-phthalimidoglutarimide) was first marketed as a sedative-hypnotic in 1957. It was withdrawn from the market in 1961 as it was found to cause congenital malformations.1 Infant mortality statistics in Germany for the years 1959 to 1963 show that about 40% of thalidomide-affected babies died in the neonatal period.2 The main causes of death were atresia of the bowel, renal dysgenesis and heart malformations. As a result of extensive studies on the pathogenesis of the malformations, it was found that thalidomide is an immunosuppressant.3 The use of two different 14C-labelled thalidomide preparations showed that a portion or the whole of the glutarimide molecule binds to the DNA of rabbit embryos.4 In Britain and Ireland, 480 thalidomide-affected infants survived. Of these, 25 died before reaching the age of 40 years. The causes of death were cancer (4), heart disease (4), diabetes (3), hypertension and renal failure (3), motor accidents (3), and substance misuse or suicide (8) (M Johnson, Director, the Thalidomide Trust [United Kingdom], personal communication). Four deaths from cancer before the age of 40 years in a cohort of 480 is an incidence of 0.83%. The death rate from cancer in England and Wales before the age of 40 is 9.4 per 100 000 population, or 0.0084%.5 Thus, the thalidomide-affected individuals had a 99-fold increase in the age-related cancer death rate. Another of the cohort died aged 41 years of round-cell sarcoma. The high incidence of malignancy, together with the knowledge that a portion of the thalidomide molecule binds with the DNA of laboratory animals, suggest a possible mutational change in some of the cells of thalidomide-affected people. Thalidomide is currently being used to treat a variety of diseases, some because of its immunosuppressant properties. These diseases include graft-versus-host disease, leprosy, AIDS, Behçet's syndrome, tuberculosis, multiple myeloma and many dermatoses. It is also being used for treating some cancers. Its chemotherapeutic value probably results from the ability of the glutarimide component of the thalidomide molecule to bind with the DNA of rapidly dividing cells. However, if the genetic injury is not accurately repaired, it may result in mutations or even cell death. Although thalidomide is now proving to be a useful therapeutic agent, its ability to bind with DNA makes it dangerous, not only when taken by pregnant women, but also potentially when taken by men, whose sperm might be affected.6
William McBride
Current prescribing patterns of bupropion in Australia
To the Editor: Bupropion hydrochloride was listed on the Pharmaceutical Benefits Scheme (PBS) on 1 February 2001 for use as short-term adjunctive therapy for high nicotine dependence, with the goal of maintaining abstinence. Supply is limited to one application per year, with no repeats, and a maximum quantity of 120 tablets at a dispensed cost of $238.95. From the beginning of February to the end of December 2001, 351 772 bupropion prescriptions had been processed by the Health Insurance Commission (HIC) at a cost of $83.14 million.1 This is equivalent to about 2% of total PBS-related drug expenditure in Australia.2 Given this high cost, it is reasonable to consider the extent to which this investment represents value for money. An important first step is to assess the penetration of bupropion into the population of regular smokers in Australia. One indicator of this is the proportion of regular smokers who have filled a bupropion prescription (Box). Estimates suggest that 22.8% of the population aged 20 years and over (25.2% males and 22.8% females) are current regular smokers.3 Seventy-three per cent (14 099 273) of the Australian population were aged 20 years or over in June 2001.4 Combining population and age-specific smoking prevalence estimates results in an estimated 3 198 738 current regular smokers aged 20 years and over. Given that the PBS guidelines allow for only one prescription of bupropion per smoker per year, an estimated 11% (351 772 prescriptions divided by 3 198 738 smokers) of current regular smokers filled a prescription for bupropion in 2001. Excluding smokers aged less than 20 years will have minimal effect on this estimate, as the incidence of high nicotine dependence in this group is likely to be low. Applying this method to each State and Territory reveals marked variation between them in the apparent proportions of smokers filling a prescription for bupropion. For example, an estimated 16.5% of all smokers in Tasmania had such a prescription filled, compared with 8% in Victoria. Although data from the HIC may be incomplete,5 the same method is applied to each jurisdiction in compiling them. Key unanswered questions relate to the extent to which (i) smokers complete a full course of bupropion, (ii) the field effectiveness of bupropion in aiding smoking cessation is comparable with abstinence rates achieved in clinical trials, and (iii) bupropion is used in conjunction with a comprehensive treatment program. We are currently conducting research to examine such questions. Characteristics of bupropion use in Australian States and Territories, February to December 2001, inclusive ACT WA Vic Tas SA Qld NT NSW Total Population (≥ 20 years) 225 797 1 372 378 3 550 348 338 108 1 110 897 2 602 539 131 542 4 767 664 14 099 273 Current regular smokers (≥ 20 years) 53 448 316 608 804 455 74 507 245 553 593 268 33 254 1 077 132 3 198 225 Bupropion prescriptions processed 4 470 46 186 64 482 12 279 32 455 81 619 3 803 106 478 351 772 Total cost of prescriptions processed $1 043 863 $10 854 828 $15 253 431 $2 920 481 $7 713 913 $19 237 576 $881 709 $25 238 851 $83 144 652 Proportion of current regular smokers who used bupropion 8.4% 14.6% 8.0% 16.5% 13.2% 13.8% 11.4% 9.9% 11.0%
Christopher M Doran · Anthony P Shakeshaft · Jennifer A Gates · Julia E Fawcett · Richard P Mattick
Allergy to hydroxycobalamin, with tolerance of cyanocobalamin
To the Editor: Cyanocobalamin and hydroxycobalamin are synthetically derived preparations of vitamin B12. Allergy to vitamin B12 injection is infrequent, but may be serious. We describe a patient with allergy to hydroxycobalamin, without cross-reaction to cyanocobalamin. Our patient was a 45-year-old woman with vitamin B12 deficiency. She had positive antiparietal cell antibodies and normal results of Schilling's test after addition of intrinsic factor. Otherwise she was in good health, with no other evidence of autoimmune disease. Her allergy commenced after an intramuscular injection of hydroxycobalamin, with onset of mild generalised pruritus. Subsequent monthly 1 mg injections of hydroxycobalamin were followed by incrementally worsening pruritus, and then frank urticaria. The last of nine injections was followed by urticaria, bronchospasm and oropharyngeal angioedema, which responded to administration of adrenalin. The patient underwent skinprick and intradermal testing with hydroxycobalamin and cyanocobalamin. Wheal-and-flare reactions occurred with injection of dilutions of hydroxycobalamin, suggesting an IgE-mediated response. No reactions were evident with dilutions of cyanocobalamin (Box). Subsequently, the patient had no reaction to a challenge of subcutaneously administered cyanocobalamin 0.1 mL (100 μg), and then intramuscularly administered cyanocobalamin 0.5 mL (500 μg). Her macrocytic anaemia resolved with ongoing monthly injections. After one year of treatment, the patient described an episode of delayed urticaria after a routine cyanocobalamin injection. The skinprick and intradermal tests were repeated, with negative reactions to cyanocobalamin, and wheal-and-flare reactions to hydroxycobalamin. She has since tolerated monthly intramuscular cyanocobalamin for over 12 months. Vitamin B12 allergy is rare, but has been reported.1-3 Positive results of basophil histamine release assay and skin testing suggest an IgE-mediated mechanism.2 Desensitisation is therefore theoretically possible; however, anaphylaxis during desensitisation has occurred.3 In Australia, both hydroxycobalamin (Neo-cytamen, David Bull) and cyanocobalamin (Cytamen, David Bull) are available. The excipients of each preparation are identical — sodium chloride, glacial acetic acid, and sterile water. Although the risk of severe allergy is low, adequate facilities for resuscitation should be available when parenteral vitamin B12 is administered. One approach to dealing with vitamin B12 allergy is to use the alternative compound after skin testing to exclude cross-reactivity. If cross-reactivity occurs, then desensitisation may be considered. Alternatively, oral administration of vitamin B12 may also be used.4 Results of skinprick and intradermal testing with hydroxycobalamin and cyanocobalamin* Dilution Saline (negative control) Morphine (positive control) Hydroxycobalamin Cyano-cobalamin Skinprick 1 : 1000 Negative Positive Positive Negative Intradermal 1 : 100 Negative Positive Positive Negative Intradermal 1 : 10 Negative Positive Positive Negative * A positive reaction was a wheal greater than that of the positive control.
David Heyworth-Smith · Patrick G Hogan