Volume 168 Issue 10

Abstract Objective: To determine the health-related quality of life (HRQOL) of Australian men after radical prostatectomy. Design: Cross-sectional study. Setting: Private and public practices of three urologists in south-east Queensland, July 1989 to June 1995. Participants: 140 men with no evidence of disease recurrence 1 to 6 years after radical prostatectomy. Main outcome measures: Voiding and erectile potency and HRQOL. Recall of preoperative status and status at survey were established by an independently administered multi-item questionnaire. Results: 112 men (80%) completed the study questionnaire. Difficulty with bladder control before the operation was reported by 25 (22%; 95% confidence interval [CI], 15%-31.2%), and the incontinence rate after treatment was 22/112 (20%; 95% CI, 12.7%-28.2%). Men with incontinence after operation were more likely to recall preoperative urinary symptoms. Eighty-four (75%) men were happy or coping with their sexual function after radical prostatectomy despite an erectile potency rate of only 12% (95% CI, 7%-20%). Twenty-eight (25%) had tried penile injections and three have had penile prostheses since their operation. Impotence was reported more frequently (40%) as the treatment-related problem most affecting life, followed by "concern about cancer" (12%) and incontinence (8%). Impotence was also the most common cause given for diminished HRQOL. Conclusions: Loss of sexual function after radical prostatectomy is more commonly perceived as a major problem and is more likely than urinary incontinence to adversely affect HRQOL. Loss of sexual function and its effect on HRQOL needs to be given greater emphasis in counselling before radical prostatectomy. MJA 1998; 168: 483-486 Introduction Prostate cancer is the second most common cause of cancer-related death in Australian men, and in 1989 became the most common cancer in men in New South Wales.1 This increase may be partly attributed to a more health-conscious, ageing population, as well as greater use of "routine" digital rectal examination (DRE) and prostate-specific antigen (PSA) tests.2 PSA tests, together with DRE and transrectal ultrasound-guided prostatic biopsies, have enabled the diagnosis of potentially curable early-stage prostate cancer.3 In particular, increased efforts have been made to identify early-stage prostate cancer in men under 70 years of age, even though a significant survival advantage has yet to be demonstrated. Screening and case detection remain controversial. There is argument about whether the tests are sufficiently sensitive and specific for effective screening, and whether screening affects outcomes enough to be cost effective.4,5Opinions also differ regarding the optimal management of localised prostate cancer.6 In men over 70 years of age, or in those with appreciable co-morbidity, a conservative approach is generally accepted. Healthy younger men are more likely to live long enough to experience progression of their disease, so radical prostatectomy and radiotherapy, as well as "watchful waiting", are options in this group. Judging by current published studies, these options may provide similar outcomes in selected patients: up to 10 years after diagnosis, similar survival rates are seen in patients treated immediately with surgery or radiotherapy, and in patients initially watched and then treated with androgen ablation, transurethral resection or radiotherapy if the disease progresses.7 This has created a significant dilemma for both doctor and patient when selecting appropriate treatment.6 The lack of a clearly superior treatment option makes the impact of treatment on health-related quality of life (HRQOL) of greater importance. The difficulty in selecting appropriate treatment is compounded by a lack of Australasian data on the effect of treatment on HRQOL. Radical prostatectomy has been increasingly used in treating patients with localised prostate cancer and is considered an appropriate option for men who have a life expectancy in excess of 15 years.8 Despite improved surgical technique, postoperative impotence and incontinence may still occur, although the reported incidence varies considerably.9 Our study was undertaken to record patients' perception of HRQOL after radical prostatectomy, to assist patients, families and doctors in their discussions about treatment expectations and outcomes. Methods Sample Surgical audit data were collected prospectively on all patients having radical prostatectomy between July 1989 and June 1995. Three of us (P S H, A N J and L C T) performed the operations. We all receive referrals from other specialist urologists, and perform most of the radical prostatectomies in Queensland. We believe that the patients studied are likely to be representative of the Australian population, although there are no data currently available from other States or Territories. We selected for review patients who had no evidence of recurrent or residual disease to avoid any effect treatment failure may have had on HRQOL. No evidence of disease was defined as a PSA level less than 0.1 µg/L and no abnormal signs and symptoms at the last clinic visit. Men operated on less than a year before the survey were excluded as complications may still resolve during this period.9 As complications are likely to remain stable after one year, we believe the cohort to be homogeneous for the purposes of studying the effects of radical prostatectomy on HRQOL. To minimise recall bias, we included only patients operated on less than six years earlier. Non-surgical factors, such as co-morbidity and ageing, were thought to be unlikely modifiers of HRQOL during this period, so that most of the changes seen could be attributed to the prostatectomy. We decided that post-hoc subgroup analysis of a cross-sectional study with small numbers was of limited value so we included patients in the survey regardless of whether nerve sparing (which may affect postoperative potency) was contemplated or performed. Comparisons with non-surgical therapies may be facilitated by this approach. Definitions We defined urinary incontinence as the need to wear incontinence pads regularly, and defined erectile potency as the ability to achieve an erection firm enough for sex more than once a month. Questionnaire As higher complication rates are usually reported in studies in which patients are reviewed independently of their treating physician,10 our questionnaire was administered independently (by R J B). Each patient was telephoned before the questionnaire and a letter of explanation was mailed. They were assured of confidentiality, that the questionnaire was being administered independently of their treating doctor and that their answers would have no impact on management of their condition. Patients who had not replied within one month were sent one reminder. As there is no current internationally validated HRQOL questionnaire for patients with prostate cancer,11 two of us (D L N and R J B) developed the questionnaire. The initial questions collected demographic data; there were 16 items about bladder and sexual function, with similar questions to check for internal consistency; and another five items assessed postoperative therapies (such as penile injections and prostheses) and satisfaction with treatment. As our questionnaire is a new tool, only some sections have been validated.10,12-14 The questionnaire assessed men's perceptions of their urinary, sexual and overall function during the month before receipt of the questionnaire. (This is a recognised method used in other validated scoring systems.15,16) Urinary symptoms and erectile function, at the time of the survey and before surgery, were assessed on a five-point scale and included severity, effect and bothersomeness of symptoms. Satisfaction with treatment and willingness to have the same treatment again were also assessed on a five-point scale. An edited version of the Functional Assessment of Cancer Therapy Scale was used to assess health, social life and satisfaction with life.14 Statistical analysis We calculated exact confidence intervals (CI) and Fisher's exact tests using the STATA statistics package.17 Results Respondents Of 185 men having radical prostatectomy, 140 had no evidence of disease at last review. One of these 140 died in a motor vehicle accident and three more were lost to follow-up. Completed questionnaires were received from 112 (80%) men whose ages at the time of survey were normally distributed around the mean of 64 years (range, 54-73). Urinary incontinence There were 22 (20%; 95% CI, 12.7%-28.2%) respondents with postoperative urinary incontinence (Box). Those with more severe incontinence were more likely to report urge incontinence or mixed stress and urge incontinence. Twenty-five respondents (22%; 95% CI, 15%-31.2%) recalled "trouble with bladder control" before surgery, although none required pads. Seventeen of the 25 (68%; 95% CI, 46.5%-85%) were incontinent after the operation, compared with only 5 of the 87 (6%; 95% CI, 2%-13%) who did not recall having problems before surgery. That is, men with urinary incontinence after radical prostatectomy were much more likely to recall preoperative urinary symptoms. There was no statistically significant association between age and postoperative continence, nor was there any association with level of education or area of residence (Fisher's exact test). Urinary symptoms did not interfere with daily activities in 93 (83%; 95% CI, 75%-85%) respondents, and 89 (79%; 95% CI, 71%-86%) were either very happy or happy with their present bladder function. Erectile potency Of the 112 respondents, 99 (88%; 95% CI, 81%-94%) recalled preoperative erectile potency, but only 14 (12%; 95% CI, 7%-20%) described erectile potency at survey. Although only 14 were potent, 23 (20.5%; 95% CI, 13.5%-29%) were happy and 61 (54.5%; 95% CI, 45%-64%) were coping with their level of sexual function. Since surgery, 28 of the respondents (25%) have tried penile injections and three (2.7%) now have a penile prosthesis. Of the 13 men who were impotent before surgery, two have tried penile injections and one has had a penile prosthesis. There was no statistically significant association between postoperative impotence and age, level of education or place of residence (Fisher's exact test). Health-related quality of life Most respondents enjoyed a high HRQOL -- 104 (93%) were satisfied with their life and with their social life. Nearly all respondents reported good general health. The most common problem affecting their lives was impotence (44 men; 40%), followed by "concern about cancer" (13 men; 12%) and "bladder problems" (9 men; 8%). Despite the high prevalence of impotence, 104 (93%; 95% CI, 80.5%-97%) respondents were satisfied with their treatment and 98 (88%; 95% CI, 80%-93%) would opt for the same treatment again. Impotence was the most common reason given for treatment dissatisfaction (7/8) and reluctance to have the same treatment again (8/14). A final section asked about "any other problems related to your surgery which affects your quality of life". One man had a problem with a lack of pad-disposal facilities in golf club toilets, and one, although potent, said that loss of ejaculation left him unsatisfied. Discussion Our questionnaire was designed to examine specific problems of incontinence, impotence and patients' perception and satisfaction with treatment and feeling of well-being after radical prostatectomy. We found impotence to be the most common cause of diminished HRQOL, followed by "concern about cancer" and then incontinence. The preoperative urinary difficulty and impotence rates in our study are similar to those in other published prospective series,18,19 and our postoperative results lie within the range of the results of other published studies,10 suggesting that our questionnaire and study design are valid. Differences between our results and those of others may be explained by our case selection and independent data collection. In Australia, initial presentation of men with prostate problems during the study period was usually prompted by lower urinary tract symptoms. Men with troublesome urinary symptoms are more likely to have detrusor instability, a factor that commonly predisposes them to incontinence after radical prostatectomy.20 Our respondents reported a 20% incontinence rate and 22% recalled preoperative urinary difficulties. In contrast, Steiner et al reported an 8% incontinence rate after radical prostatectomy,21 but the more widespread screening for prostate cancer in the United States2-5 makes it likely that their patients were referred after screening and may not have had incontinence problems. The methods by which data are collected may also affect reporting of incontinence. Other studies that also used independent data collection15,22 have reported higher rates of incontinence (31% and 47%, respectively). We found that men with postoperative incontinence were much more likely to recall preoperative symptoms. However, we advise caution in interpreting this apparent strong association because of the limitations of cross-sectional studies (such as only measuring subjects' status once and not taking account of variation in patients' condition, including only those with successful treatments, and not yielding true relative risks) and the potential effects of recall bias. Patients with incontinence after surgery may have thought more about their predicament and been more likely to recall preoperative urinary symptoms; and, conversely, those continent after the operation may have had urinary symptoms before the operation but did not recall being troubled by them. Nevertheless, specific enquiry regarding urinary symptoms is advised when discussing treatment options with patients with localised prostate cancer, and those with urinary symptoms need to be informed of the association with urinary incontinence after radical prostatectomy. Lack of preoperative symptoms, however, does not guarantee postoperative continence as 6% of this group were incontinent after the operation. The preoperative impotence rate in our patient group is similar to that reported by Jonler et al. Men in their study were of similar age, and data were collected prospectively in a community setting.19 After the operation 12% of our respondents were potent, which is similar to the rates Jonler et al22 and Fowler et al10 reported (16% and 11%, respectively), but lower than the 70% found by Quinlan et al.23 Recall bias, case selection and independent data collection, as discussed for incontinence, are also plausible explanations for these differences. Impotence was much more likely to be reported as a major quality-of-life problem than incontinence, which is consistent with other series.12,24 Loss of potency as a cause of diminished HRQOL is not specific to radical prostatectomy, as Jonler et al concluded in their study of 1680 men attending a cancer screening program "impotent men have a lower QOL than potent men".19 Many men are prepared to trade off survival for sexual potency,25 so some men may choose a treatment with possibly lower long-term survival to increase their chance of remaining potent. The impact of radical prostatectomy and other treatments on potency should be discussed in detail when counselling patients with localised prostate cancer before therapy. However, erectile potency and a happy sex life do not go hand-in-hand, as 75% of respondents were happy or coping with their sexual function but only 12% claimed postoperative potency. This may be because people who have made a treatment decision are likely to believe, and want others to believe, that they have made the right choice,24 especially if they are disease free, as this group were. References Coates M, McCredie M, Armstrong BK. Cancer in New South Wales. Incidence and mortality, 1993. Sydney: NSW Cancer Council; 1996. McCredie M, Coates M, Churches T, Rogers J. The rising incidence of prostate cancer in Australia -- a result of "screening"? J Epidemiol Biostat 1996; 1: 99-105. McCaul KA, Luke CG, Roger DM. Trends in prostate cancer incidence and mortality rates in South Australia, 1977-1993. Med J Aust 1995; 162: 520-522. Hirst GHL, Ward JE, Del Mar CB. Screening for prostate cancer: the case against. Med J Aust 1996; 164: 285-288. Kaye KW. Prostate cancer: enthusiasm for screening. Med J Aust 1995; 162: 540-541. Whitmore WF Jr. Management of clinically localized prostatic cancer -- an unresolved problem [editorial]. JAMA 1993; 269: 2676-2677. Chodak GW, Thisted RA, Gerber GS, et al. Results of conservative management of clinically localized prostate cancer. N Engl J Med 1994; 330: 242-248. Freedman G, Hanlon M, Lee W, Hanks G. Young patients with prostate cancer have an outcome justifying their treatment with external beam radiation. Int J Radiat Oncol Biol Phys 1996; 35: 243-250. Madsen F, Bruskewitz R. Functional results of radical prostatectomy. Curr Opin Urol 1995; 5: 246-248. Fowler JF Jr, Barry MJ, Lu-Yao G, et al. Patient-reported complications and follow-up treatment after radical prostatectomy. The National Medicare Experience: 1988-1990 (updated June 1993). Urology 1993; 42: 622-629. Borghede G, Karlsson J, Sullivan M. Quality of life in patients with prostate cancer: results from a Swedish population study. J Urol 1997; 158: 1477-1486. Brickman AL, Soloway MS. Quality of life 12 months after radical prostatectomy. Br J Urol 1995; 75: 48-53. Herr HW. Quality of life of incontinent men after radical prostatectomy. J Urol 1994; 151: 652-654. Cella DF, Tulsky DS, Gray G, et al. The Functional Assessment of Cancer Therapy Scale: development and validation of the general measure. J Clin Oncol 1993; 11: 570-589. O'Leary MP, Barry MJ, Fowler FJ Jr. Hard measures of subjective outcomes: validating symptom indexes in urology. J Urol 1992; 148: 1546-1548. Barry MJ, Fowler FJ Jr, O'Leary MP, et al. Correlation of the American Urological Association symptom index with self-administered versions of the Madsen-Iversen, Boyarsky and Maine medical assessment program symptom indexes. J Urol 1992; 148: 1558-1563. STATA statistics package [computer program]. Version 5.0. Texas: Stata Corp; 1996. Diokno A, Brock BM, Brown M, Herzog A. Prevalence of urinary incontinence and other urological symptoms in the non-institutionalised elderly. J Urol 1986; 136: 1022-1025. Jonler M, Moon T, Brannan W, et al. The effect of age, ethnicity and geographical location on impotence and quality of life. Br J Urol 1995; 75: 651-655. Goluboff E, Chang D, Olsson C, Kaplan S. Urodynamics and the etiology of post prostatectomy urinary incontinence: the initial Colombia experience. J Urol 1995; 153: 1034-1037. Steiner MS, Morton RA, Walsh PC. Impact of radical prostatectomy on urinary continence. J Urol 1991; 145; 512-515. Jonler M, Messing EM, Rhodes RR, Bruskewitz RC. Sequelae of radical prostatectomy. Br J Urol 1994; 74: 352-358. Quinlan DM, Epstein JI, Carter BS, Walsh PC. Sexual function following radical prostatectomy: influence of preservation of neurovascular bundles. J Urol 1991; 145: 998-1002. Litwin MS, Hays RD, Fink A, et al. Quality of life outcomes in men treated for localized prostate cancer. JAMA 1995; 273: 129-135. Singer PA, Tasch E, Stocking C, et al. Sex or survival: trade-offs between quality and quantity of life. J Clin Oncol 1991; 9: 328-334. (Received 7 Apr 1997, accepted 24 Feb 1998) Authors' details Princess Alexandra Hospital, Brisbane, QLD. Peter S Heathcote, FRACS, Urologist; Peter N Mactaggart, FRACS, Urologist; Robyn J Boston, MB BS, Urology Registrar; Leslie C Thompson, FRACS, Urologist; David L Nicol, FRACS, Urologist. Royal Brisbane Hospital, Brisbane, QLD. Anthony N James, FRACS, Urologist. Reprints will not be available from the authors. Correspondence: Dr D L Nicol, Department of Urology, Princess Alexandra Hospital, Ipswich Road, Brisbane, QLD 4102. E-mail: D. NicolATmailbox.uq.edu.au Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia ".

Peter S Heathcote · Peter N Mactaggart · Robyn J Boston · Anthony N James · Leslie C Thompson · David L Nicol

Abstract Objective: To ascertain the effectiveness of a home vaccination service for children behind in their vaccination schedule. Design: Randomised controlled trial of nurse-administered vaccination at home. Children were allocated at random to the intervention or the control group before any contact with the parents was made. Setting: 10 council areas in north-west metropolitan Melbourne defined by 56 postcode zones. Six-week intervention period from November 1996. Participants: 405 children -- all those in the study area (n = 2610) 90 days late (age 9 months) for their third diphtheria-tetanus-pertussis/poliomyelitis/Haemophilus influenzae type B (DTP/OPV/Hib) vaccination, or 120 days late (age 16 months) for their measles-mumps-rubella (MMR) vaccination, according to the Australian Childhood Immunisation Register. Main outcome measures: Number of children completing DTP/OPV/Hib or MMR during the intervention period, and number up to date before intervention. Results: Verification of vaccination status with the parents revealed that 123 (60%) of the children in the intervention group and 113 (56%) of those in the control group were up to date with their vaccinations, leaving a study population of 81 (intervention group) and 88 (control group). Vaccination was achieved in 46 (57%) intervention children and 24 (27%) control children (risk ratio [RR], 2.08; 95% CI, 1.4-3.1; P < 0.001). For DTP/OPV/Hib, 18/32 (56%) intervention children and 12/36 (33%) control children were vaccinated (P = 0.06). For MMR, 28/49 (57%) and 12/52 (23%) children were vaccinated, respectively (P < 0.001). Home vaccinations were completed with 26 families (including five siblings). The average cost per child vaccinated as a result of the home program was $92.52. Conclusion: Home vaccination for children behind in their immunisation schedule is an effective, acceptable and relatively cheap method of completing recommended vaccinations. We recommend that a home vaccination program be widely implemented and made available, particularly for disadvantaged families. Introduction In Australia, incomplete immunisation of children under 2 years of age remains an important public health problem. Many children never complete their immunisation schedule or are many months overdue.1 Uptake rates are lowest for measles-mumps-rubella vaccination at age 12 months and the diphtheria-tetanus-pertussis booster at 18 months.1-3 Being late for a primary course is predictive of being late for or missing subsequent vaccinations.3,4Parents' beliefs about the seriousness of the vaccine-preventable illnesses and the safety and efficacy of vaccines are important predictors of vaccination uptake.5 However, there are other barriers to children being vaccinated -- frequent minor childhood illnesses, parental forgetfulness, and advice from health providers to delay vaccinations.6-10 A current strategy to overcome barriers to vaccination is to make vaccination more accessible, but parents are still required to bring their children to be vaccinated. For some families, however, it may be more effective to take the vaccination service to the child. We have explored (i) the effectiveness of offering a home vaccination service to children at greatest risk of not completing their immunisation schedule by age 2 years; and (ii) the usefulness of the Australian Childhood Immunisation Register (ACIR) for identifying these at-risk children. Method Participants The Australian Childhood Immunisation Register provided identifying information for children living in 10 local council areas in north-west metropolitan Melbourne (defined by 56 postcode zones) who were either born January 1996 and 90 days late for their third diphtheria-tetanus-pertussis/poliomyelitis/Haemophilus influenzae type B vaccination (DTP/OPV/Hib; 1st milestone), or born June 1995 and 120 days late for their measles-mumps-rubella vaccination (MMR; 2nd milestone). The intervention period comprised six weeks from November 1996. Making contact to verify vaccination status before randomisation would have in itself constituted an intervention. Therefore, before any contact was made with the parents, the children were allocated at random (by computer) to the intervention or the control group. Contact We made initial contact with the intervention group by letter, then by telephone one to three weeks later to verify vaccination status, to organise an appointment, and to administer a pre-vaccination health check as recommended by the National Health and Medical Research Council's Australian immunisation handbook.11 This health check was to ensure that the child did not require special medical attention and could be vaccinated at home. If no telephone contact could be made, two follow-up letters were sent. As local councils and maternal and child health nurses provide a substantial number of childhood vaccinations in Victoria and maintain vaccination records, we checked these (possible) providers for vaccination details if parents could not be contacted. Children were confirmed as either overdue for vaccination or up to date with vaccination if parents, the local council or the maternal and child health nurse provided a record of the vaccination. Intervention The study was approved by the Royal Children's Hospital Ethics in Human Research Committee. Parents signed a consent form to participate in the study and a standard State Government vaccination consent form. A nurse administered vaccination in the child's home at a time convenient to the parents. Siblings were also vaccinated if they were due for vaccination. The nurse providing the vaccination had completed a standard Victorian Government Department of Human Services immunisation course. A resuscitation kit (including adrenalin) was taken on each home visit, and the cold chain was maintained by transporting vaccines in a temperature-monitored car refrigerator. Before vaccination, the nurse administered a pre-vaccination health checklist11 to confirm the child's medical history, as obtained during the initial telephone contact, and to assess the child's health on the day of vaccination. Vaccines that were due were verified from the parent-held Child Health Record. The child's temperature was taken if he or she was hot or appeared unwell (a temperature > 38.58c precludes vaccination11). Paracetamol was offered to all children before vaccination. The nurse remained with the family for more than 20 minutes after vaccination. The visits included time for parents to complete questionnaires about immunisation service use, reasons for the delay in vaccination, education level, family size and whether the family had a Health Care Card. (A Health Care Card is a Federal Government card available to low income families, including those receiving government pensions, to obtain concessions for health and medical expenses; ie, it is an indicator of disadvantage or poverty.) Neither written consent nor sociodemographic information was obtained from parents who chose to have their child vaccinated by another provider, or whose child was up to date with immunisation, or who refused to take advantage of the home service. Follow-up of control children Two months after the intervention period, and based on updated information from the Australian Childhood Immunisation Register, we sent letters to parents of control children for whom neither the Register nor local councils had recorded a third DTP/OPV/Hib or an MMR vaccination. We followed the letters with a telephone call to verify vaccination status and to offer, in this case, vaccination at the Royal Children's Hospital. Parents of control children were also informed of local vaccination services offered by the maternal and child health nurse or of the schedules of mobile vaccination vans provided by local councils. No sociodemographic information was collected from the parents of control children. Cost analysis Costs included travel, estimated at $0.50 per kilometre, nursing time at $25 per hour, consumables (excluding vaccines) as charged by the Royal Children's Hospital and clerical work at $17 per hour for 18 days. Statistical analysis Sample size was estimated assuming that 35% of intervention children would accept vaccination and 6% of control children would be immunised. This would require 30 in each group, with a set at 0.05 and statistical power 80%. Statistical associations were assessed with chi-squared tests. Confidence intervals and risk ratios were calculated with the STATA program.12 Results Subjects There were 2610 children born in June 1995 or January 1996 in the study area and registered with the Australian Childhood Immunisation Register. Of these, 416 children (16%) were identified by the Register as overdue for their third DTP/OPV/Hib or MMR. The Figure shows the number of children on the Register meeting the study criteria, the number excluded and the vaccination status of the children in the intervention and control groups at the time of contact. On verification of vaccination status with parents, 123 (60%) of the intervention children and 113 (56%) of the control children were confirmed as being up to date with their immunisation schedule, and therefore were ineligible for the intervention, leaving 81 children in the intervention group and 88 control children. Those whose status could not be verified were assumed for analysis to be unvaccinated. In total, 2430 (93%) children were up to date with their vaccinations at the beginning of the study period: 1219 (95%; 95% confidence interval [CI], 93.6%-96.0%) 9-month-old children and 1211 (92%; 95% CI; 90.8%- 93.8%) 16-month-old children. Intervention Table 1 shows the number of children vaccinated during the intervention period. To estimate the effect of the intervention on uptake for the full cohort, the cohort was divided into two equal groups (n = 1305 each). The number of children immunised in the group with the intervention children increased from 1220 (93.5%) before intervention to 1266 (97%) after intervention. The group with the control children increased from 1210 (93%) to 1234 (95%). Using similar logic, but dividing for type of vaccine, in the group with intervention children the rate for 1st milestone vaccination increased to 98% and for 2nd milestone to 97%, whereas the rates for the group with control children increased to 96% and 94%, respectively. The mean (SD) age for DTP/ OPV/Hib vaccination for intervention and control children was 10 (0.2) months and 11.5 (0.3) months, respectively (which was significantly different; P < 0.001), compared with 7 (1.3) months for children having DTP vaccination before study commencement. The mean (SD) age for MMR vaccination for intervention and control children was 17.2 (0.1) months and 19 (0.3) months (P < 0.001), compared with 14 (1.7) months for those having MMR vaccination before study commencement. In the intervention group 26 children were immunised by the study nurse and 19 by their doctor or local council service. One child who had a severe egg allergy was vaccinated at the Royal Children's Hospital Immunisation Adverse Events Clinic. Ten children due for MMR were also given their 18-month DTP/Hib boosters and five siblings were brought up to date with their vaccination schedule. In all, 82 vaccines were administered to study children and siblings. On the day of vaccination 13 children had colds or were taking antibiotics; none had a fever. All were vaccinated as arranged. Two families refused the service because they were against immunisation and 22 families preferred to use their own doctor. As mentioned, 19 did so within the study period. One mother changed her mind about home vaccination because of concern about her child's egg intolerance. The child was vaccinated a month after the intervention by her doctor. Table 2 summarises the demographic information of those immunised at home and major reasons given by parents for delayed vaccinations. Costs The mean cost per child vaccinated in the intervention group was $92.52, and the mean cost per visit per vaccine was $52. These costs excluded cost of visits to the general practitioner by those being vaccinated by their own doctor. Fifty-one per cent of the cost was attributable to clerical time needed to verify vaccination status. Travel costs were 12% of total costs and 33% of nurses' costs. Discussion We have shown that offering home vaccination is an effective method of bringing children (and their siblings) up to date with their immunisation schedule. Importantly, we used information from a population-based register, and thus provided vaccinations for children in socially disadvantaged families. Such families have been identified previously by the Australian Bureau of Statistics13 and others14 as being most at risk of not completing the scheduled childhood immunisations. A major finding of this study was the unexpectedly high proportion of children already vaccinated at the commencement of the study. This proportion was substantially higher than expected from previous statewide estimates -- 95% v. 84% for 1st milestone vaccination and 92% v. 78% for 2nd milestone vaccination2 -- and exceptionally high given that our study was conducted in a socially disadvantaged area. Data for our study on children's vaccination status were from Australian Childhood Immunisation Register enrolments, which are derived from Medicare data and miss about 2% of children; however, this would have had a minimal impact on these vaccination estimates. It is also unlikely that substantial misclassification of vaccination status occurred. While we did not formally cross-check vaccination dates, when dates were obtained from two sources 85% matched. When dates differed it cannot be assumed that Register dates were correct. In some cases vaccinations reported to the Register by us were incorrectly recorded or missing. Thus, we found the usefulness of the Australian Childhood Immunisation Register as a source of accurate information to be limited. However, our study was undertaken in the first year of the Register's existence and it is expected that accuracy of the Register will improve. Limitations of this study arise from the need to randomise the population sample before verification of immunisation status. This has the potential to introduce bias because of the possibility of differences in response between the intervention and control groups. Another limitation was the number of children in each group with whom no contact was made. However, these limitations are unlikely to have caused substantial bias. In both groups a similar number of control (56%) and intervention children (60%) were excluded because they were up to date with vaccinations, and likewise the proportion of control (15%) and intervention children (14%) who could not be contacted to determine immunisation status was similar. There is also no reason to suppose that any differences in vaccination rates between these two uncontacted groups would be sufficient to bias the estimate of the intervention effect. Assuming that 50% of the children in each group who could not be contacted were vaccinated, the risk ratio for vaccination would be 1.67 (95% CI, 1.3-2.2; P < 0.001). Itinerancy is a risk factor for incomplete and late vaccination,3,15 making it not surprising that a considerable number considered overdue for vaccination could not be contacted. We have shown that those who can be contacted can be vaccinated. A similar program that accesses vaccination information at a local level may be more efficient at targeting families who move frequently. It is obvious that a home service will cost more than mass vaccination programs. The cost per vaccine, taking into account only nurses' time and travel costs, was about $23, which compares favourably with the £8 reported by an outreach program in the United Kingdom.16 The costs of the service would be reduced with improved accuracy of Australian Childhood Immunisation Register information (clerical costs would be reduced by 50%), by offering a local rather than a centralised service (travelling costs would be reduced by 30%), and by incorporating the vaccination service into a broader home visiting program to promote child health and support disadvantaged families in this endeavour. As indicated by many studies,17-22 a barrier to age-appropriate immunisation is often not parental unwillingness to have their child vaccinated, but immunisation providers failing to provide a service. About a third of the parents of children behind in their vaccinations reported having recently consulted a doctor. In almost all these cases the child could have been vaccinated at that time. To prevent diseases such as measles, immunisation rates need to exceed 95%.23 Even the high uptake rates found at the commencement of our study are below this level. Innovative and proactive methods are necessary to attain these high levels and have been found to be effective.15,24 Acknowledgements This study was funded by National Health and Medical Research Council (NHMRC) project grant number HS371. Lyndal Bond was funded by an NHMRC Scholarship. We would like to thank the research nurse (Michelle Wills), the Royal Children's Hospital Immunisation Adverse Events Clinic for providing a service for children in the intervention and control groups, and local council health departments for their cooperation. References Australian Bureau of Statistics. Children's immunisation Australia. Canberra: ABS, April 1995, 1996. (Catalogue No. 4352.0.) Lester R, Norris P. 1994/5 Pre-school immunisation coverage. Notifications for Victoria, July-September 1995. Health Protection Update (Public Health Division, Department of Human Services, VIC) 1995; 3: 10-13. Hanna CJ, Wakefield JE, Doolan CJ, Messner JL. Childhood immunisation factors associated with failure to complete the recommended schedule by two years of age. Aust J Public Health 1994; 18: 15-24. Li J, Taylor B. Factors affecting uptake of measles, mumps, and rubella immunisation. BMJ 1993; 307: 168-171. Peckham C, Bedford H, Senturia J, Ades A. The Peckham Report National Immunisation Study: factors influencing immunisation uptake in childhood. Horsham: Action Research For The Crippled Children, 1989. Jones K, Fasher B, Hanson R, et al. Immunisation status of casualty attenders: risk factors for non- compliance and attitudes to "on the spot" immunisation. J Paediatr Child Health 1992; 28: 451-454. Miles TA, Merrell WH. An outbreak of measles in the Hunter area of New South Wales. Aust J Public Health 1992; 16: 302-304. New SJ, Senior ML. "I don't believe in needles": qualitative aspects of a study into the uptake of infant immunisations in two English health authorities. Soc Sci Med 1991; 33: 509-518. Harding GC. How can the uptake of vaccines be increased? J Inst Health Educ 1984; 22: 5-11. Adjaye N. Measles immunisation: some factors affecting non-acceptance of vaccine. Public Health 1981; 95: 185-188. National Health and Medical Research Council. The Australian immunisation handbook. 6th ed. Canberra: AGPS, 1997. Stata Statistical Software [computer program], Release 5.0. College Station, Tex: Stata Corporation, 1997. Australian Bureau of Statistics. 1989-90 National Health Survey children's immunisation, Australia. Canberra: AGPS, 1992. Bazeley P, Kemp L. Childhood immunisation: the role of parents and service providers. A review of the literature. Canberra: National Immunisation Programme, Commonwealth Department of Human Services and Health, AGPS, 1994. Pearson M, Makowiecka K, Gregg J, et al. Primary immunisations in Liverpool II: is there a gap between consent and completion? Arch Dis Child 1993; 69: 115-119. Jefferson N, Sleight G, MacFarlane A. Immunisation of children by a nurse without a doctor present. BMJ 1987; 294: 423-424. MacIntyre R, Nolan T. Attitudes of Victorian vaccine providers to pertussis vaccine. Med J Aust 1994; 161: 295-299. Burgess MA. Pertussis vaccine -- time to stop the confusion. Med J Aust 1994; 161: 293-294. Begg NT, Nicholl A. Immunisation. BMJ 1994; 309: 1073-1075. Stevens D, Baker R, Hands S. Failure to immunise against whooping cough. Arch Dis Child 1986; 61: 382-387. Kinder J, Teare L, Rao M, et al. False contraindications to childhood immunisation. Br J Gen Pract 1992; 42: 160-161. Askew GL, Finelli L, DeGraaf J, et al. Beliefs and practices regarding childhood vaccination among urban pediatric providers in New Jersey. Pediatrics 1995; 96: 889-892. Nolan T. Measles -- eradication or procrastination? Med J Aust 1990; 152: 449-450. Birkhead GS, LeBaron CW, Parsons P, et al. The immunisation of children enrolled in the special supplemental food program for women, infants and children (WIC). JAMA 1995; 274: 312-316. (Received 29 Sep 1997, accepted 6 Apr 1998) Authors' details Clinical Epidemiology and Biostatistics Unit, Department of Paediatrics, University of Melbourne, Royal Children's Hospital, Melbourne, VIC. Lyndal M Bond, MA(ApplPsych), NHMRC Scholar. Terry M Nolan, PhD, FRACP, FAFPHM, Head, Clinical Epidemiology and Biostatistics Unit. Department of Human Services, Melbourne, VIC. Rosemary A Lester, MB BS, MPH, FAFPHM, Head, Infectious Diseases Unit. Reprints: Ms Lyndal Bond, Clinical Epidemiology and Biostatistics Unit, Department of Paediatrics, University of Melbourne, Royal Children's Hospital, Parkville, VIC 3052. E-mail: bondATcryptic.rch.unimelb.edu.au Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia ".

Lyndal M Bond · Terry M Nolan · Rosemary A Lester

Abstract Objective: To describe the results of vaccinating children with a history of serious adverse reactions after vaccination or of egg allergy at a special clinic established for that purpose. Design: Retrospective case series. Patients: Children who attended the clinic between 1 August 1994 and 31 July 1996 after being referred by vaccine providers. Setting: A clinic conducted in the Emergency Department of The Canberra Hospital, Australian Capital Territory. Main outcome measures: Reasons for referral; vaccinations given; and subsequent adverse vaccination events. Results: 91 children received 155 vaccinations at the clinic, and only one serious event -- a hypotonic/hyporesponsive episode (HHE) after diphtheria-tetanus-whole-cell pertussis (DTPw), oral polio and Haemophilus influenzae type b vaccination -- was subsequently reported; this child recovered spontaneously. Fifty-three children referred because of a previous serious adverse vaccination event were revaccinated at the clinic with whole-cell pertussis vaccine (47), combined diphtheria and tetanus vaccine (4), tetanus toxoid (1), and typhoid vaccine (1). Three children (referred because of previous meningitis, subdural haemorrhage or parental suspicion of allergy to DTPw) received their first dose of pertussis vaccine at the clinic. The remaining 35 children had a history of egg allergy and were given measles-mumps-rubella vaccine. Conclusions: We successfully vaccinated children with histories of serious reactions to vaccination, including HHEs, convulsions, apnoea, high temperatures and persistent screaming, as well as those with egg allergy. We believe special clinics can improve vaccination coverage. Introduction In 1995, there were almost 10 000 reported cases of vaccine-preventable disease in Australia.1 In that same year, an Australian Bureau of Statistics survey found only 52% of children were fully vaccinated, and that advice against vaccination or concern about the side effects were among the main reasons for missing vaccination.2 Reactions do occur after vaccination, but these are usually mild. They are often caused by the whole-cell pertussis component.3 While it is rarely necessary to delay or avoid subsequent vaccinations in children who have had reactions4 if the reaction was serious, continuing vaccination can be a very difficult decision for both parents and vaccination providers. The Canberra Hospital (formerly Woden Valley Hospital) in the Australian Capital Territory services a population which includes approximately 22 000 children aged less than five years. In August 1994, a special clinic was established to provide vaccination under close medical supervision for children who had had a serious adverse event after a previous vaccination or who had a history of egg allergy (at one time considered a contraindication to measles-mumps-rubella vaccination). We report the results of vaccinations provided to children in the first two years of the clinic. Similar clinics have been established in the United Kingdom,5,6 but data from an Australian setting have not previously been published. Methods The clinic was conducted fortnightly (occasionally more frequently) in The Canberra Hospital's Emergency Department. We accepted children who met the national surveillance definition of a serious adverse event after vaccination (Box 1, below),7 except those who had had encephalopathy within seven days of vaccination or an immediate severe allergic or anaphylactic reaction, both of which contraindicate further vaccination.8 We also accepted children with egg allergy who required measles- mumps-rubella (MMR) vaccine. Local vaccination providers, including medical practitioners and community nurses, received a written protocol for referral of children and were asked to direct referrals through the Immunisation Coordinator at ACT Health & Community Services. Medical practitioners were also advised about the clinic through a seminar series and in bulletins from ACT Health & Community Services. We asked providers to establish the nature and severity of the reaction and not to refer children whose parents were merely anxious about vaccination. On referral, parents were provided with written information about the risks and benefits of vaccination and, if appropriate, an appointment was made with the clinic. Parents were advised to give children paracetamol (15 mg/kg) at 8:00 am on the day of the clinic and to attend at 8:50 am. A paediatrician examined each child before vaccination and discussed the relevant history with the parent; we did not confirm egg allergy by means of skin tests. For each child, the injection site, vaccine, batch number and any adverse event after vaccination at the clinic was recorded. Electronic images of these records were stored in the hospital database. Parents were advised that children should remain under observation at the clinic for two hours after vaccination, and were provided with an information sheet on paracetamol use after vaccination. They were urged to contact the clinic if any adverse event occurred after leaving the hospital, but were not otherwise routinely followed up. We used the national surveillance criteria (Box 1)7 to define serious events after vaccination at the clinic. The reason for each referral and, where applicable, vaccines associated with the previous adverse event were retrospectively recorded in a database. Data on vaccines given at the clinic, length of stay and subsequent adverse events were obtained retrospectively from hospital records. Any record of subsequent attendance at the hospital was also checked to identify adverse events after vaccination at the clinic (The Canberra Hospital is the only public hospital with paediatric services in the ACT). The two-year study period was from 1 August 1994 to 31 July 1996. Epi Info version 6.04 was used to analyse the data.9 Results Fifty-two clinics were conducted over the two years. No more than five children attended on any one day. Overall, 91 children received 155 vaccinations during 110 visits (eight children attended twice, three attended three times, and one attended six times). Reasons for attendance were a serious adverse vaccination event (53), egg allergy (35), seizure associated with meningitis (1), subdural haemorrhage in infancy (1), and possible allergy to diphtheria-tetanus-whole-cell pertussis (DTPw) vaccine on the basis of family history (1). The median age of all children attending the clinic at the first visit was 14 months (range, 2 months to 15 years). Of the 53 children attending because of a previous vaccination event, 21 (40%) were aged 3 to 8 months; those attending because of egg allergy were aged 10 months to 15 years, while the three remaining children were aged 2 to 5 months. The male:female ratio was 1.2:1. Five children were referred to the clinic but did not attend; three were subsequently vaccinated by their general practitioners and two -- one referred because of a previous adverse vaccination event and one because of egg allergy -- were lost to follow-up. Box 2 shows that, of the previous serious adverse vaccination events for which 53 children were referred, all but one occurred after DTPw vaccination, and persistent screaming (> 3 hours) was the most frequent reaction. For 29 of these children (55%) the adverse event occurred after the first dose of vaccine, for 15 (28%) after the second, for six (11%) after the third, and for three (6%) after the fourth. At the clinic, 47 of these children were revaccinated with one dose of whole-cell pertussis vaccine in the form of DTPw or monovalent pertussis, four received combined diphtheria and tetanus vaccine (CDT), one received tetanus toxoid, and one received typhoid vaccine. Haemophilus influenzae type b vaccine (Hib), oral polio vaccine (OPV), and MMR vaccines were also provided where appropriate. Three other children (referred because of previous meningitis, subdural haemorrhage or parental suspicion of allergy to DTPw) received their first dose of pertussis vaccine at the clinic. None of the 35 children referred because of egg allergy had experienced anaphylaxis after egg or were considered severely allergic; all were vaccinated at the clinic with MMR vaccine. During 110 visits, 88 children were observed for two hours, 16 for three hours, two for four hours and one for six hours (19 children were observed for longer than the stipulated period because of parental concern only). The three remaining children were observed for one hour (leaving at the request of their parents) and included two who received MMR and one (referred because of suspected allergy to DTPw) who received DTPw, OPV and Hib. No adverse events were recorded during the clinic observation period. No child vaccinated with MMR had any adverse event reported after discharge from the clinic. Similarly, no adverse events were reported after discharge for any of the 20 children referred because of persistent screaming; of these, 19 received one dose of a whole-cell pertussis vaccine at the clinic. The remaining child received CDT. One child aged six months had a serious adverse event (hypotonic-hyporesponsive episode [HHE]) eight hours after vaccination with DTPw, OPV and Hib at the clinic. This child had been referred because of similar episodes, once three hours after receiving the first course of DTPw, OPV and Hib, and then again six hours after receiving the second course. The episode, which occurred at home, lasted only a few minutes and the child recovered spontaneously; a doctor was not consulted. This child was subsequently vaccinated with MMR at 12 months and revaccinated with DTPw and Hib (fourth dose) at 18 months by the child's usual vaccine provider. The parent reported that the child had suffered no further episodes. Four other children who had previously had an HHE after DTPw vaccination were revaccinated with DTPw at the clinic and no further episodes were reported. The absence of further episodes was confirmed for three of these children when they made subsequent visits to the clinic; the parent of the fourth child was contacted and confirmed that no further episodes had occurred (vaccination was completed through the child's usual vaccine provider). Mild reactions were reported for two children vaccinated at the clinic. The first, aged two months, screamed persistently for an unspecified duration after receiving DTPw, OPV and Hib. The child had not been previously vaccinated and was attending because of a suspected allergy to DTPw. After assessment, the paediatrician did not consider the child's reaction severe enough to warrant supervision of subsequent vaccinations at the clinic and recommended routine vaccination by the child's usual vaccine provider. The second child, aged 16 months, had a high temperature (level unspecified) and local reaction after receiving DTPw (third dose) and Hib. Although this is considered a mild reaction, the parent did not consent to a further dose of DTPw. CDT was provided at a subsequent visit, without any reported reaction. Discussion We successfully vaccinated children with a history of serious reactions to vaccination, including HHEs, convulsions, apnoea, high temperatures and persistent screaming, as well as children with a history of egg allergy. HHEs are rare, but are known to occur after receipt of pertussis vaccines.3 They have previously been shown to have no neurological or long term sequelae on follow-up.10 One child vaccinated at the clinic with DTPw (third dose), OPV and Hib reportedly had an HHE (which we were not able to validate as it occurred after discharge from the clinic). As recovery from these episodes can be quick,10 it is often necessary to rely on a parent's description. This child, who had also had an HHE after each of the two previous DTPw vaccinations, received a fourth dose of DTPw from the child's usual vaccine provider, and the parent confirmed that no further HHE had occurred. We successfully revaccinated four other children who had had an HHE. We believe the results from our clinic support the National Health and Medical Research Council (NHMRC) recommendation that an HHE does not usually contraindicate further doses of pertussis vaccine.3We cannot discount the possibility that serious reactions occurred after vaccination at the clinic, but were not reported. However, as serious reactions had been reported previously for these children, and as they had attended the clinic and their parents had been encouraged to report any adverse event after discharge, we consider this unlikely. Only two children vaccinated with DTPw at the clinic experienced mild reactions (these would not contraindicate further doses of pertussis-containing vaccines).3,4 However, we had expected that more mild to moderate reactions would be reported. Deloria et al found that children who had had common reactions to pertussis vaccination (including a temperature of over 38¡C and swelling and redness at the injection site) were approximately 1.5 to 8 times more likely to experience the same reaction at a subsequent vaccination.11 After DTPw vaccination, about 50% of children will have swelling or redness at the injection site, 30% will have a high temperature and approximately 30% will be inconsolable or cry persistently.3 The small number of minor reactions detected in our study may reflect under-reporting after discharge, but may also be the result of prophylactic paracetamol use.3 We do not know the total number of ACT children who experienced a serious adverse vaccination event making them suitable for referral to the clinic. However, we do know that 36 618 doses of DTPw vaccine were given in the ACT during the period of our study (Julie Donda, ACT Health & Community Services, personal communication). The Australian immunisation handbook estimates that the rate for persistent screaming (> 3 hours) after DTPw vaccination is about 1/100 doses, while for HHEs and convulsions the rates are 1/300 to 1/30 000 doses, and about 1/1750 doses, respectively.3 In comparison, the referral rates for children attending our clinic were persistent screaming, 1/1800 doses; HHEs, about 1/7000 doses; and convulsions, about 1/12 000 doses. This suggests that referral rates were low, except, possibly, for HHE. Perhaps there is a need to raise awareness among vaccine providers and parents of both the existence of the clinic and of the importance of reporting serious adverse events. Hospital-based clinics such as ours provide an important service in addressing the immediate concerns of both parents and providers. We used whole-cell pertussis vaccine, but the recent introduction of acellular pertussis vaccine may further improve acceptability, particularly for parents who are not prepared to continue with DTPw vaccine. The use of acellular pertussis vaccines should reduce the incidence of mild to moderate reactions, but its impact on the incidence of serious reactions is not yet clear.12 Active follow-up after vaccination at the clinic is now being undertaken and we believe this should improve identification of delayed reactions and encourage completion of outstanding vaccinations. It is possible that detection of serious adverse events after vaccination at the clinic would be further improved by increasing the observation time if this is indicated by previous history. Over time, the clinic should provide reassurance to both parents and vaccine providers by practically demonstrating the safety of vaccines, but the service should be reserved for those most at need. Children with egg allergy and those with persistent screaming after vaccination made up over half of the patients attending the clinic, and all were successfully vaccinated. The NHMRC currently recommends that a paediatrician be consulted if there is genuine concern over possible egg allergy, with a view to vaccination under controlled conditions such as those in our clinic.3 What constitutes genuine concern is unclear, but we believe that only those with severe reactions considered appropriate by an experienced paediatrician, such as anaphylaxis to egg, should be referred to the clinic. Both parents and vaccine providers need to be reassured that most children with egg allergy, those who have screamed persistently after vaccination, and perhaps some others, can and should be vaccinated through their usual vaccine providers.3,13 We believe the clinic is an essential component of the ACT's immunisation program, improving vaccination coverage by vaccinating children who may otherwise remain unvaccinated or incompletely vaccinated, and by encouraging reporting of adverse vaccination events. Similar clinics for children with serious adverse reactions to vaccination and severe allergies, such as anaphylaxis to egg, should be encouraged in all States and Territories. We believe children with mild to moderate reactions (including persistent screaming) should be revaccinated through their usual vaccine provider. It is essential that all vaccine providers are well informed of the recommendations for vaccination, particularly with respect to contraindications.3 We should all endeavour to ensure that children are vaccinated in accordance with the recommended schedule. Acknowledgements We thank Yvonne Epping for her support and assistance as Immunisation Coordinator at ACT Health & Community Services; the staff of the Emergency Department at The Canberra Hospital who conducted the clinics; the vaccination providers for their cooperation in referring patients; and Dr Christine Roberts of the National Centre for Epidemiology and Population Health for her comments on the manuscript. The Master of Applied Epidemiology Program is funded by the Commonwealth Department of Health and Family Services. References Herceg A, Oliver G, Myint H, et al. Annual report of the National Notifiable Diseases Surveillance System, 1995. Commun Dis Intell 1996; 20: 440-464. Australian Bureau of Statistics. Children's immunisation. Australia April 1995. Canberra: ABS, 1996. (Catalogue No. 4352.0.) National Health and Medical Research Council. The Australian immunisation handbook. 6th ed. Canberra: AGPS, 1997. The Australian College of Paediatrics policy statement. Contraindications to immunization against pertussis. J Paediatr Child Health 1994; 30: 310-311. Ko MLB, Rao M, Teare L, et al. Outcome of referrals to a district immunisation advisory clinic. Commun Dis Rep 1995; 5: R146-R149. Newport MJ, Conway SP. Experience of a specialist service for advice on childhood immunisation. J Infect 1993; 26: 295-300. Curran M, Herceg A. Surveillance data in CDI. Commun Dis Intell 1997; 21: 8. National Health and Medical Research Council. The Australian immunisation procedures handbook. 5th ed. Canberra: AGPS, 1994. Dean AG, Dean JA, Coulombier D, et al. Epi Info [computer program]. Version 6. A word processing, database, and statistics program for epidemiology on microcomputers. Atlanta, Ga: Centers for Disease Control and Prevention, 1994. Barraff LJ, Shields WD, Beckwith L, et al. Infants and children with convulsions and hypotonic-hyporesponsive episodes following diphtheria-tetanus-pertussis immunization: follow-up evaluation. Pediatrics 1988; 81: 789-794. Deloria MA, Blackwelder WC, Decker MD, et al. Association of reactions after consecutive acellular or whole-cell pertussis vaccine immunizations. Pediatrics 1995; 96 (3 Suppl): 592-594. Decker MD, Edwards KM, Steinhoff MC, et al. Comparison of 13 acellular pertussis vaccines: adverse reactions. Pediatrics 1995; 96 (3 Suppl): 557-566. Aickin R, Hill D, Kemp A. Measles immunisation in children with allergy to egg. BMJ 1994; 309: 223-225. (Received 30 Oct 1997, accepted 21 Jan 1998) Authors' details National Centre for Disease Control, Commonwealth Department of Health and Family Services, and National Centre for Epidemiology and Population Health, Canberra, ACT. Ross M Andrews, MPH, DipAppSci(Env Health), Master of Applied Epidemiology Student; Ana Herceg, MB BS, MPH, Medical Epidemiologist. South Australian Health Commission, Adelaide, SA. Ann E Kempe, MSc(Hons), RN, Manager, South Australian Immunisation Unit. Emergency Department, The Canberra Hospital, ACT. Kam K Sinn, MB BS, FRACP, Paediatrician. Reprints will not be available from the authors. Correspondence: Mr R M Andrews, Department of Human Services, Level 17, 120 Spencer Street, Melbourne, VIC 3000. E-mail: ross.andrewsATdhs.vic.gov.au Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia ".

Ross M Andrews · Ann E Kempe · Kam K Sinn · Ana Herceg

Public health and politics: the demise of the ACT heroin trial To the Editor: Wodak cites the support of the Australian Medical Association for the proposed ACT heroin trial in his editorial.1 The Federal Executive of the AMA supported the trial but the Queensland Branch (AMAQ) opposed it. The basic premise of Wodak's editorial is that stopping the trial showed lack of support for evidence-based medicine. AMAQ opposed the trial on the grounds that there was little scientific evidence, and what evidence there was came only from Switzerland and much of it was dubious at best. A view was expressed at AMAQ Council that the proposed stages of the trial were an unpleasant experiment on Australian society. The reason for Wodak's response lies in the second paragraph of his editorial, where he refers to the lucrative profits from trafficking of illicit drugs. Wodak and the trial's supporters appear to believe that liberal use of free heroin would threaten the profits of drug traffickers, but for that to be so heroin would have to be widely available in the community. Thus, the purpose of the trial was not to determine efficacy, as the authors of the trial, like Wodak, knew the outcome -- the introduction of free heroin throughout Australia. Christopher J Alroe Member, Australian Medical Association Queensland Branch Council; and Senior Consultant, Rockhampton District Mental Health Service, PO Box 4055, Rockhampton, QLD 4700 Wodak AD. Public health and politics: the demise of the ACT heroin trial [editorial]. Med J Aust 1997; 167: 348-349. Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company. Journalists are welcome to write news stories based on what they read here, but should acknowledge their source as "an article published on the Internet by The Medical Journal of Australia ".

Christopher J Alroe