Letters Website: bmj.com Email:
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GMC’s proposals for revalidation Purpose of revalidation process must be agreed on Editor—Southgate and Pringle outlined the General Medical Council’s proposals for revalidation, the reasoning behind them, and how they might be implemented in general practice and, by implication, other specialties.1 The proposals adhere to international guidelines,2 but Wakeford has challenged them as being potentially unfair, unacceptable, and expensive.3 The portfolio based assessment described by Southgate and Pringle and advocated by the government and royal colleges has face validity. If blueprinted to provide evidence about all aspects of good medical practice, it should also be valid in content. However, Wakeford questions the fairness and reliability of the judgments to be made by the team of assessors. This is a credible objection because, while portfolio based assessment is a valuable technique for formative assessment, evidence of its reliability as a summative assessment tool is not yet convincing. Advocating this approach when the stakes are potentially so high seems to create a problem with the advent of evidence based medicine and best evidence medical education. Wakeford’s solution also has flaws. Although an exercise administered on paper or computer as the basis for revalidation might answer some concerns about reliability, it would raise serious questions about validity. Such testing could not provide a measure of performance in practice and at best could only provide evidence about some aspects of competence. It would not provide information on many parts of clinical practice that worry the public and discredit the profession. The method for revalidation should be both practical and technically defensible. To achieve this, the purpose of the revalidation process must therefore be agreed on. Currently, the two purposes are being confused. The first is to identify seriously underperforming doctors. The second is to support all doctors in striving constantly to improve their performance. The methods of achieving these purposes need to be different. The prevalence of seriously underperforming doctors is believed to be low ( < 5%), so identifying them requires an inexpensive screening procedure with high sensitivity but low specificity. Doctors so identified would undergo a second stage set 358
of procedures with high specificity. An option for this screening might be the use of peer and patient ratings as developed by the American Board of Internal Medicine.4 The second stage could be the current performance procedures already used by the GMC, which include an assessment of performance in practice and the combination of a written and practical test of clinical competence.5 The second purpose needs more discussion to establish the most fitting combination of methods, taking into account the best evidence available. There also needs to be a response to the concerns expressed by Wakeford about the feasibility and cost of planned approaches. David Newble professor Department of Medical Education, University of Sheffield Medical School, Sheffield S5 7AU
[email protected] 1 Southgate L, Pringle M. Revalidation in the United Kingdom: general principles based on experience in general practice. BMJ 1999;319:1180-3. 2 Newble D, ed. Guidelines for the development of effective and efficient procedures for the assessment of clinical competence. In: Newble DI, Jolly BC, Wakeford RE. The certification and recertification of doctors: issues in the assessment of clinical competence. Cambridge: Cambridge University Press, 1994. 3 Wakeford R. GMC’s proposals for revalidation would not be accurate, economical, or fair. BMJ 2000;321:1220. (11 November.) 4 Ramsey PG, Weinrich MD, Carline JD, Inui TS, Larson EB, LoGerfo JP. Use of peer ratings to evaluate physician performance. JAMA 1993;269:1655-60. 5 General Medical Council. Performance procedures—a guide to the arrangements. London: GMC, 1999.
Appraisal is helpful only if done well Editor—I am writing in response to Wakeford’s letter criticising the General Medical Council’s proposals for revalidation.1 Annual appraisal can be helpful, but GMC and NHS proposals are seen as controversial by many general practitioners. Doctors have been told we will be appraised, but there are too many unanswered questions—for example, who will appraise? Although it has been widely assumed that general practice tutors will appraise general practitioners, no official statement has been made to this effect. Tutors with whom I have spoken are willing to consider appraising colleagues in a supportive, non-threatening, formative context, given acceptable training, resources, and ground rules, but they do not wish to be inquisitors for Department of Health searching for “bad” doctors. Many general practitioners fear that appraisal could be used as a managerial rather than an educational and supportive tool. Educationalists hope to see appraisal
develop as something that will produce happier, better trained general practitioners and identify those doctors who are in difficulty at a remedial stage. This process will occasionally identify a doctor whose practice is unacceptable and who may need to be guided towards another career, but to design the whole process around this tiny minority would have a destructive effect outweighing any benefits. There are many good general practitioners in their 50s whose mortgage is paid off, whose spouse has agreeable and well paid employment, and whose children are through university. If appraisal and revalidation are introduced in the wrong way and without adequate resources, some of these doctors will retire earlier than they would have done. If this happens on any scale, it would undo all the good that might be done by identifying a couple of hundred underperforming doctors. Annual appraisal can be used as a tool to promote quality of care for patients and also to support doctors, but at present many general practitioners see it as more of a threat than an opportunity. Questions about the selection, training, remit, and funding of appraisers must be answered satisfactorily and quickly if general practitioners are to have faith in the process. Stephen Hayes general practice tutor White House Surgery, Southampton SO19 9HJ
[email protected] The Wessex General Practice Tutor Group, including SH, has indicated a willingness to take on an appraisal role if satisfactorily funded. 1 Wakeford R. GMC’s proposals for revalidation would not be accurate, economical, or fair. BMJ 2000;321:1220. (11 November.)
Effective revalidation system looks at how doctors practise and quality of patients’ experience Editor—Wakeford made several interesting points about the development of revalidation.1 To start we must recall the objective of revalidation, which is to detect poor performance and encourage doctors to improve their practice. The General Medical Council’s proposals recognise that revalidation is more than a sieve. The GMC must be sure that the same outcome would occur were a folder to be considered by any revalidation group. Hence it emphasises the need for training. The GMC has much experience in training assessors for its performance procedures. (We are also aware of the work done by the Royal College of General Practitioners’ examination board both on training assessors and through its calibration exercises.) Hence the GMC is developing robust exterBMJ VOLUME 322
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Letters nal quality assurance mechanisms and working with the royal colleges and others to develop explicit standards. The GMC is also concerned with reliability. Guidance and training are important. The GMC will test its assumptions, as shown by the piloting programme led by one of us (PM). Piloting will also help estimate the costs and benefits of revalidation. There are problems in asking doctors to sit tests to demonstrate their fitness to practise. Firstly, the blueprint used must be good medical practice. This is the basis for registration and for the GMC’s regulatory work including the performance procedures. The importance of working to a blueprint is accepted.2 A test based system could only partly cover the blueprint. Tests are not good ways to capture information about communication skills and team working. Secondly, such tests would not reflect what doctors do. Van der Vleuten, for example, says that there is overwhelming evidence that the reliability of measurements of clinical competence is hampered by the fact that competence is content specific and that achieving competence in one area (as in one clinical case) is not a good predictor of competence in another, even if the areas are closely connected.3 What is true of undergraduate examinations must be true for postgraduate ones. Thirdly, an examination based approach would send wrong messages to the profession. “Consequential validity” (the problems of assessment driven learning) is important. It would be better for doctors to prepare for revalidation by addressing their actual practice than by spending time in libraries. The GMC is ahead of much of the rest of the world in developing an effective revalidation system—one that looks at how doctors practise and at the quality of patients’ experience, not at whether doctors can jump through hoops. Brian Jolly professor of medical education Department of Medical Education, University of Sheffield, Coleridge House, Northern General Hospital, Sheffield S5 7AU Pauline McAvoy chief executive Gateshead and South Tyneside Health Authority, Ingham House, Horsley, South Shields NE33 3BN Lesley Southgate professor of primary care and medical education Centre for Health Informatics and Multiprofessional Education, London N19 3UA 1 Wakeford R. GMC’s proposals for revalidation would not be accurate, economical, or fair. BMJ 2000;321:1220. (11 November.) 2 Newble DI, Jolly BC, Wakeford RE. The certification and recertification of doctors: issues in the assessment of clinical competence. Cambridge: Cambridge University Press, 1994. 3 Van der Vleuten, C. Validity of final examinations in undergraduate medical training. BMJ 2000;321:1217-9.
Author’s reply Editor—Annual appraisal is an excellent idea—talking confidentially with colleagues about your successes and failures, and translating the outcome into an action plan for your professional development over the next year cannot but improve the medical profession’s competence overall. But if these BMJ VOLUME 322
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annual appraisals were to be included in a five year portfolio of evidence to determine whether you can continue in practice, would you be so candid about your problems, mistakes, and needs? It seems unlikely. Formative and summative assessment do not mix. The method of assessment every five years proposed by the General Medical Council—“portfolio based assessment”—is a comparatively new approach with a slender research base. Individual assessors differed substantially in how they judged the adequacy of portfolios.1 Many assessors will be needed to assess around 20 000 a year, and assessors will set different standards—as the GMC’s planned piloting will doubtless confirm.2 Each candidate for revalidation will also seemingly have his or her unique set of assessors, compounding the likely inaccuracies. The assessors could of course be trained, but for the numbers concerned—three per doctor—substantial training seems improbable, and its impact is impossible to estimate. Its costs would add greatly to those already suggested: training a professional person costs at least £500 a day. For a fraction of the expense of the proposed quinquennial review two better options are open to the GMC: x The first, though probably the less acceptable,2 is formal written and computer based testing by a professional testing body (such as the National Board of Medical Examiners in the United States). Accurately estimating a doctor’s likely competence in practice would take no more than a day using modern testing procedures x The second is a system of confidential peer review in which colleagues who know a doctor’s practice are asked to rate her or him on a standardised form. These ratings reflect true levels of performance well, are quick and cheap to collect,3 and can be complemented by similarly straightforward patient inputs. Although the GMC may be developing some interesting new procedures,2 its record on quality assurance in assessing the competence of doctors is unimpressive. For example, it was not easily persuaded to close the back door of entry to the profession via the Society of Apothecaries.4 The large differences in the apparent quality of output of British medical schools5 seems not to have attracted its attention or led to the establishment of a national medical qualifying examination—or even research into differences between medical schools. Credible revalidation is essential, professionally and politically. But now that the medical workforce is becoming increasingly pressed the GMC must not be allowed to introduce revalidation procedures that are flawed in concept, hideously expensive in time and money, and potentially inaccurate and unfair. Richard Wakeford convenor, Cambridge Conferences on Medical Education Hughes Hall, Cambridge CB1 2EW www.cambridgeconferences.org
1 Pitts J, Coles C, Thomas P. Educational portfolios in the assessment of general practice trainers reliability of assessors. Med Educ 1999;33:515-20. 2 Jolly B, McAvoy P, Southgate L. Revalidation. bmj.com 2000;321 (www.bmj.com/cgi/eletters/321/7270/1220# EL7; accessed 1 Feb 2001). 3 Ramsey PG, Weinrich MD, Carline JD, Inui TS, Larson EB, LoGerfo JP. Use of peer ratings to evaluate physician performance. JAMA 1993;269:1655-60. 4 Wakeford RE. LMSSA: a back door entry into medicine? BMJ 1987;294:890-1. 5 Wakeford R, Foulkes J, McManus C, Southgate L. MRCGP pass rate by medical school and region of postgraduate training. BMJ 1993;307:542-3.
GMC assessment of Fergusson case was not at fault Editor—As an elected member of the General Medical Council who has just become a screener but who had no involvement with the Fergusson case, I disagree with the criticism by Jarvis of those who instigated the GMC conduct procedures.1 The screener must decide whether a complaint raises a question of serious professional misconduct. If so, he or she must then refer the case to the preliminary proceedings committee, which will decide whether it should be referred to the professional conduct committee. If not, the screener’s judgment must be endorsed by a lay screener. If the lay screener disagrees, the case will go to the preliminary proceedings committee. There is no requirement for cases to be dealt with by a doctor from the same specialty as the doctor complained against before or at the professional conduct committee. Expert opinions can, however, be sought at any stage. No gynaecologist may thus have seen this case before it reached the professional conduct committee, and there was no gynaecologist on the panel that heard it. Rather than criticising those who considered that Fergusson’s conduct raised a question of serious professional misconduct, I would question the decision of the panel that he was not guilty of serious professional misconduct. Although I accept from reading the transcripts that Fergusson may have thought he was acting in the patient’s best interests, this needs to be set against the patient’s reaction. By 1990, when the Department of Health had changed the standard NHS consent form, unanticipated surgery other than that needed to save a patient’s life could clearly not be carried out. The events had a devastating effect on the patient, who had consented to hysterectomy only in what she was told was the rare event that the uterus might be perforated. She never consented to oophorectomy. The mitigating factors were that the doctor had had an otherwise blameless career and acted in good faith but the underfunding of the NHS system left insufficient time for him to spend with the patient. He had to rely on doctors in training to obtain consent and did not know the patient’s views accurately, although a medical student tried to raise her objections when major surgery was contemplated. The most appropriate GMC response in such cases is probably to admonish the doctor (as in the case of John Studd) or to 359
Letters take no action, accepting that the process of appearing in front of the professional conduct committee is sufficient to protect patients in the future and to reinforce the need for doctors to obtain informed consent. Some women, however, may not agree. Many still see our branch of the profession as paternalistic and dismissive of women’s views. Wendy Savage honorary professor, Middlesex University London N1 8HN 1 Jarvis GJ. Expert witnesses who are out of step should be named and shamed. BMJ 2000;321:111. (8 July.)
Routine vaccination and child survival in Guinea-Bissau Authors’ reply to commentary Editor—In his commentary on our paper Fine claims that our observations lack the classic attributes of causality: gradient, strength, and coherence.1 Firstly, the estimates only just reach conventional significance. However, the important finding was not the significance of the estimates for the individual vaccines but the fact that BCG and diphtheria, pertussis, and tetanus vaccines had opposite effects on mortality—the difference being strongly significant (P = 0.005). Secondly, the association of diphtheria, pertussis, and tetanus vaccine with increased mortality could be due to higher vaccination coverage and higher mortality among children of young mothers. However, as we stated in our paper, adjustment for background factors had minimal effect on mortality estimates. Given the low prevalence of young mothers and their slightly higher vaccine coverage (table 2), adjustment for maternal age had little effect. Mortality ratios changed from 1.84 (1.10 to 3.10) to 1.82 (1.08 to 3.07) with one dose of diphtheria, pertussis, and tetanus vaccine and from 1.38 (0.73 to 2.61) to 1.37 (0.72 to 2.59) with 2-3 doses. Thirdly, our results may be anomalous because mortality declines with age for children who had not been vaccinated with BCG but increases with age among those who were (table 3). These findings are to be expected if diphtheria, pertussis, and tetanus vaccine increases mortality. Exposure to diphtheria, pertussis, and tetanus vaccine increased with age for children vaccinated with BCG (table below), whereas there was
little change for those who were not so vaccinated. Presumably children who are not vaccinated with BCG have less contact with immunisation services and are therefore less likely to receive additional doses of diphtheria, pertussis, and tetanus vaccine during follow up. Fourthly, the mortality ratio of 1.84 (1.10 to 3.10) for one dose of diphtheria, pertussis, and tetanus vaccine declined to 1.38 (0.73 to 2.61) for 2-3 doses. This difference is not significant (P = 0.250) and we did not discuss it, but we mentioned in the discussion that the estimates were conservative because they were based on initial vaccination status and had to ignore subsequent vaccinations during follow up. Children who had received 2-3 doses of diphtheria, pertussis, and tetanus vaccine were more likely to receive measles vaccine during follow up (51%) than children who initially had received only one (28%) or no dose (13%). When the analysis was censored at 9 months of age to minimise interference from measles vaccinations, the mortality ratios for one dose (1.81 (1.00 to 3.26)) and 2-3 doses (1.75 (0.86 to 3.59)) were similar. We concluded that the vaccines had important non-specific effects on mortality, but we did not claim that the individual vaccines altered mortality. Moreover, the non-specific effects of diphtheria, pertussis, and tetanus vaccine may well have had gradient, strength, and coherence in our study. A more detailed version of our response to Fine’s commentary is available on bmj.com.2 Peter Aaby anthropologist Bandim Health Project, Danish Epidemiology Science Centre, Apartado 861, Bissau, Guinea-Bissau
[email protected] Henrik Jensen statistician Danish Epidemiology Science Centre, Statens Serum Institut, Copenhagen, Denmark 1 Kristensen I, Aaby P, Jensen H. Routine vaccination and child survival: follow up study in Guinea-Bissau, West Africa [with commentary by P Fine]. BMJ 2000;321: 1435-9. (9 December.) 2 Aaby P, Jensen H. Non-specific effects of vaccinations: lacking gradient, strength, and coherence? bmj.com 2000;321 (www.bmj.com/cgi/eletters/321/7274/1435#EL19; accessed 31 Jan 2001).
Lessons can be learnt from this study Editor—The paper by Kristensen et al describes improved survival in infants in Guinea-Bissau who received measles or BCG vaccines but increased mortality in those who received diphtheria, tetanus, and pertussis vaccine.1 At the request of the World Health Organization we visited
Exposure to diphtheria, tetanus, and pertussis (DTP) vaccine by age and vaccination with BCG Not vaccinated with BCG at first visit
Vaccinated with BCG at first visit
Average No of DTP doses (total No of doses/ No of children)
Percentage time with exposure to DTP* (time with DTP exposure/person years)
Average No of DTP doses (total No of doses/ No of children)
Percentage time with exposure to DTP* (time with DTP exposure/person years)
0-1
1.14 (726/635)
56 (166.3/299.1)
2.02 (872/432)
119 (244.0/204.5)
2-3
1.01 (323/321)
60 (90.4/151.0)
2.26 (1614/714)
166 (563.6/339.4)
4-6
1.07 (235/219)
70 (71.4/101.6)
2.37 (1975/832)
202 (785.3/389.0)
Age at first visit (months)
*Sum of time exposed per dose during first follow up period.
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Guinea-Bissau durng 8-15 October 2000 to review this study. We found the methods to be as described in the paper. As data collection is continuing, we were able to accompany the field staff on several visits. We reviewed the data management procedures and found them to be in order. While several potential sources of bias could be hypothesised we were not able to identify any that could invalidate the study. This is a single study, which was not originally designed to address this issue, and the methodological weaknesses have been highlighted in the accompanying editorial and commentary.1 2 By its characteristics and its surprising findings this study should provoke substantial further investigation of the subject. Although these results should not be used as a basis for changing national or global vaccination policy, they demand an immediate response. The first response from the WHO was to seek out data from other developing countries that may be used to address this question, and this is happening. Other studies may not show the same findings in relation to diphtheria, tetanus, and pertussis vaccine, in which case the particular circumstances in Guinea-Bissau should be considered. At the time of the study 25-30% of all children died before their 5th birthday, most from malaria or pneumonia, although this has not been well studied. Data from other places with high mortality and intense malaria transmission will therefore be particularly interesting. Regardless of the outcome of the ongoing investigations, the work in GuineaBissau highlights the importance of considering the overall impact of vaccines on children’s health. Thus the finding that measles and BCG vaccines seem to improve survival beyond what can be attributed to the prevention of the specific diseases is particularly good news that should stimulate similar studies in other areas. Broader lessons can be learnt from this study. Public health research to support public health interventions is not a luxury but a necessity. Up till now, the overall impact of routine childhood vaccines on survival in places with high mortality has not yet been evaluated systematically. We should learn from this omission and ensure that all public health interventions are underpinned by the appropriate public health research, both experimental and observational, to ensure that they are both safe and efficacious. Kim Mulholland professor Department of Paediatrics, Royal Children’s Hospital, Parkville, Victoria 3051, Australia
[email protected] Mauricio L Barreto professor Instituto de Saude Coletiva, Federal University of Bahia, Salvador-Bahia, Brazil
[email protected] 1 Kristensen I, Aaby P, Jensen H. Routine vaccination and child survival: follow up study in Guinea-Bissau, West Africa [with commentary by P Fine]. BMJ 2000;321: 1435-9. (9 December.) 2 Shann F. Non-specific effects of vaccines in developing countries. BMJ 2000;3231:1423-4. (9 December.)
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Letters WHO responds to Guinea-Bissau report Editor—The paper by Kristensen et al challenges the safety of diphtheria, tetanus, and pertussis vaccine, one of the principal vaccines used by national immunisation programmes.1 The authors shared their results with the World Health Organization before publication, and they cooperated in allowing the organisation to review the field sites in Guinea-Bissau and the data bank in Copenhagen. The Global Advisory Committee on Vaccine Safety of the WHO, an independent group of experts in drug safety, vaccine science, and epidemiology that advises the Department of Vaccines and Biologicals of the organisation, has closely considered the reported findings and conclusions of the paper. It has found that numerous and serious deficiencies in the paper did not allow it to reach the same definitive conclusions reached by the authors. In particular, it found that the reported observations are incomplete and do not tally, no systematic effort has been made to address the likelihood of bias introduced by the method of data collection, and categorical inferences have been drawn from data that are either not significant or critically dependent on a very small number of results that might equally be explained by chance. In addition, the probability of the results being distorted by confounding factors has not been adequately addressed. The analysis was data driven and not based on a priori generation of a hypothesis, which makes interpretation of significance values and confidence limits problematic. The conclusions of this paper need to be scrutinised to the same extent as adverse events previously mistakenly attributed to diphtheria, tetanus, and pertussis vaccine. It is important that the safety and impact of current immunisation schedules should be studied, particularly in high risk situations. WHO is committed to giving support to investigators, including Kristensen et al, to conduct such work in a robust manner. We emphasise that no change is warranted in current policy with regard to immunisation practices, including BCG, diphtheria, tetanus, and pertussis, oral polio, and measles vaccines in national immunisation schedules. Peter I Folb professor Department of Pharmacology, University of Cape Town Health Sciences Faculty, Observatory 7925, South Africa
[email protected] On behalf of the WHO Global Advisory Committee on Vaccine Safety. 1 Kristensen I, Aaby P, Jensen H. Routine vaccination and child survival: follow up study in Guinea-Bissau, West Africa [with commentary by P Fine]. BMJ 2000;321: 1435-9. (9 December.)
Authors’ reply Editor—Our observations on the nonspecific effects of vaccinations may have major implications for immunisation policies, so we invited the World Health Organization to collaborate in examining these effects. A WHO epidemiologist reviewed analyses in Copenhagen and three experts BMJ VOLUME 322
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visited Guinea-Bissau. As reported above, they did not identify problems with the data or potential bias that could invalidate our study. Folb’s letter for the Global Advisory Committee on Vaccine Safety and the WHO’s website make several unsubstantiated criticisms.1 Firstly, the criticism that our observations are incomplete and do not tally is undocumented. Secondly, that we have not systematically addressed the likelihood of bias is not true as the results and discussion sections deal extensively with potential sources of bias. Thirdly, we are said to have made categorical inferences and definitive conclusions; however, we suggest only that non-specific effects could be important as different routine vaccinations are associated with opposite trends in the survival analyses. Fourthly, the committee claims that we have not adequately addressed the probability that our results are distorted by confounding factors without even suggesting which confounding factors could produce opposite trends for different vaccines. Finally, the suggestion that our study is produced by data driven analysis is contradicted by the results of our previous vaccine studies.2–4 The importance of non-specific effects of vaccines has been evident since the early 1990s, when girls given high doses of measles vaccine were found to have a higher mortality than girls given the standard dose.2 3 Further evidence that standard measles vaccine reduces mortality from diseases other than measles was published in 1995.4 The observations of non-specific effects of routine vaccinations were unexpected in spite of previous work on high titre vaccines.2 3 When an unexpected observation cannot be tested in a randomised trial, there are two important considerations: Is the observation consistent with existing data? Can it be replicated? For high titre measles vaccines, the results from three studies from Guinea-Bissau2 and Senegal3 were consistent when we reported our studies, and the finding was later replicated in Haiti. Our current observations are consistent with previous studies of the non-specific effects of vaccines, and Folb provides no information that contradicts them.2–4 We welcome Folb’s assurance that the WHO will support further studies of immunisation in high risk populations as this will help clarify the extent to which the observations on non-specific effects are replicable. There is an urgent need for such research on vaccinations and child survival. Peter Aaby anthropologist Bandim Health Project, Danish Epidemiology Science Centre, Apartado 861, Bissau, Guinea-Bissau
[email protected] Henrik Jensen statistician Danish Epidemiology Science Centre, Statens Serum Institut, Copenhagen, Denmark 1 WHO. Routine vaccination and child survival: questions and answers. Available at: www.who.int/vaccines-diseases/ safety/hottop/routvaccine.htm; accessed 31 Jan 2001.
2 Aaby P, Knudsen K, Whittle H, Tharup J, Poulsen A, Sodemann M. Long-term survival after Edmonston-Zagreb measles vaccination: increased female mortality. J Pediatr 1993;122:904-8 3 Aaby P, Samb B, Simondon F, Knudsen K, Coll Seck AM, Bennett J. Sex specific mortality after high titre measles vaccines in rural Senegal. Bull WHO 1994;72:761-70 4 Aaby P, Samb B, Simondon F, Coll Seck AM, Knudsen K, Whittle H. Non-specific beneficial effects of measles immunization: analysis of mortality studies from developing countries. BMJ 1995;311:481-5
Vaccinations as risk factors for ill health in veterans of the Gulf war Conclusion may be flawed by inadequate data Editor—Hotopf et al’s conclusion that there is an association between ill health in veterans of the Gulf war and immunisations given during the deployment may be flawed by inadequate data.1 2 Before deployment, routine vaccinations are brought up to date and vaccinations specific to deployment are given. For the Gulf conflict a vaccination programme against biological warfare agents had to be implemented—hence the differences between immunisations given before and during deployment. The authors state that personnel received vaccines both before and during deployment, but the results indicate that only 38% of their sample did. We find this proportion to be surprisingly low. The implication that around a third of the force received no vaccinations during the deployment or that a similar proportion had none before deployment is at odds with our review of the immunisation programme.3 The finding that only some 30% of personnel received cholera vaccine before deployment is unexpected. The policy was for all to receive the vaccine before deployment, and we would expect records to reflect this. Indeed, records for 205 general hospitals show an uptake of 93% for cholera vaccine. Other apparent anomalies in the presented results suggest problems with data quality. We know that over 60% of the total force had deployed before the biological warfare immunisation programme began. We also know that there was “a high uptake—over 75% generally and closer to 100% in some units—across all three services of the first doses of anthrax and pertussis, but thereafter the uptake is reduced and the overall pattern changes.”3 We also know that codewords, such as “Cutter,” “Victor 1,” and “Biological,” were used for vaccines and appear on records that we have seen, but these are not mentioned in the paper. How were these anomalies dealt with? The Ministry of Defence has acknowledged that there were deficiencies in record keeping.4 The field medical records system was not designed for recording immunisations given during deployment, and there were deficiencies in recording immunisations before deployment. The authors do not adequately discuss this aspect of the data quality. Readers may well assume that the 361
Letters vaccination records used accurately reflect immunisations given in association with the deployment. They do not. We wonder if the only conclusion that can be drawn is that in the team’s first paper on Gulf veterans’ illnesses: that there is a weak association between multiple immunisations and illness in Gulf veterans.5 J P G Bolton medical adviser H A Lee professor, Gulf veterans’ medical assessment programme Roger Gabriel consultant physician, Gulf veterans’ medical assessment programme Ministry of Defence, Gulf Veterans Illnesses Unit, London SW1A 2HB 1 Hotopf M, David A, Hull L, Ismail K, Unwin C, Wessely S. Role of vaccinations as risk factors for ill health in veterans of the Gulf war: cross sectional study. BMJ 2000;320:1363-7. (20 May.) 2 Hotopf M. Reanalysis of Gulf war vaccination data does not contradict findings. BMJ 2000;321:761-2. (23 September.) 3 Ministry of Defence. Implementation of the immunisation programme against biological warfare agents for UK forces during the Gulf conflict 1990/91. 20 Jan 2000. At www.gulfwar.mod.uk (accessed 25 Jan 2001). 4 Ministry of Defence. Medical records in the Gulf. April 1999. At www.gulfwar.mod.uk (accessed 25 Jan 2001). 5 Unwin C, Blatchley N, Coker W, Ferry S, Hotopf M, Hull L, et al. Health of UK servicemen who served in Persian Gulf war. Lancet 1999;353:169-78.
Authors’ reply Editor—Many of Bolton et al’s points were addressed in our paper, in which we acknowledged the potential problems in ascertaining the vaccination status of participants. We limited our analysis to personnel who had kept their vaccine records. Of these, 31% gave very specific information, including batch numbers and dates of vaccination. We did a small (n = 20) telephone survey among those who did not give such specific information and found that 80% reported using their vaccine records when completing our questionnaire.1 We were aware of the code names for vaccines, but these were rarely reported by the veterans. The vaccine records were completed by Ministry of Defence medical personnel at the time when the vaccines were given. Hence we believe that over 80% of the participants in our study were using contemporaneous records to report how many, and which, vaccines they received. We believe that our records are more reliable than the data that the Ministry of Defence collected for the report that Bolton et al cite.2 This report gathered evidence by interviewing 250 unit commanders and doctors roughly eight years after the conflict. These personnel were asked to give their estimates of vaccine uptake for the men and women in their units. From this the report estimated uptake rates of various vaccinations by unit. Such data are intrinsically unreliable—they use key informants recalling events many years before, where they estimated the uptake of a multitude of vaccines, which were often given in the highly pressed atmosphere of deployment. Our work continues with a nested case-control study comparing healthy and ill veterans. In this study we are relying on Ministry of Defence medical records to ascertain vaccine exposure. The information we have so far, on 66 veterans, indicates that the 362
uptake of cholera vaccines was about 70%, which is between our original figure and that given by Bolton et al. The estimate of 30% reported in our paper is based on individuals reporting cholera vaccination in the two months before deployment. Some of the shortfall might be accounted for by individuals being prepared further in advance of deployment. Everyone, not least the Ministry of Defence, acknowledges that one of the lessons to be learnt from the Gulf war is the danger of failing to keep proper records of exposures, including those–such as vaccines– given to protect military personnel. The ministry’s efforts to remedy the inevitable “deficiencies in recording” of health interventions before deployment will certainly be to the benefit of the health of servicemen and women as well as future research. Matthew Hotopf senior lecturer
[email protected] Tony David codirector Lisa Hull research worker Khalida Ismail lecturer Catherine Unwin study coordinator Simon Wessely codirector Gulf War Research Unit, Guy’s, King’s, and St Thomas’s School of Medicine, King’s College London, London SE5 8AZ 1 Unwin C, Blatchley N, Coker W, Ferry S, Hotopf M, Hull L, et al. Health of UK servicemen who served in Persian Gulf war. Lancet 1999;353:169-78. 2 Ministry of Defence. Implementation of the immunisation programme against biological warfare agents for UK forces during the Gulf conflict 1990/91. 20 Jan 2000. At www.gulfwar.mod.uk (accessed 25 Jan 2001).
Tracheal stenosis can occur 20 years after intubation Editor—Tracheal stenosis after intubation is less rare than suggested by Spittle and McCluskey’s Lesson of the Week.1 In our tertiary referral centre we see several cases each year of patients with sequelae occurring after intubation. Complications may even occur a long time after minor events as the following case shows. A 39 year old woman was sent to our department by a pulmonologist who had
examined her because she had wheezing and dyspnoea during exercise. Her medical history was unremarkable except for an intubation that occurred during a nasal septal correction when she was 17. This intervention took 45-60 minutes. On examination in the clinic we saw a severe subglottic stenosis (figure, top). The patient was taken to the operating room where a laryngotracheoscopy was done (figure, bottom). The stenosis was dilated using a cone shaped bronchoscope. The patient’s peak flow increased from 200 l/min preoperatively to 430 l/min postoperatively. Since then, the intervention has been repeated twice, when she was 41 and 43. As these cases show, the long term sequelae of intubation can be serious. F G Dikkers otorhinolaryngologist Department of Otorhinolaryngology, University Hospital Groningen, P O Box 30001, 9700 RB Groningen, Netherlands
[email protected] 1 Spittle N, McCluskey A. Tracheal stenosis after intubation. BMJ 2000;321:1000-2. (21 October.)
Contraception in general practice before teenage pregnancy Inappropriate selection of cases and controls biased study Editor—In their case-control study, Churchill et al found that teenagers who become pregnant have higher consultation rates at general practices than their age matched peers.1 However, their conclusions may be biased by inappropriate selection of cases and controls. Churchill et al defined cases as all registered patients in the practices who had a recorded termination, delivery, or miscarriage resulting from conception. Since they ascertained cases from practice computer records, maternity books, and knowledge of practice staff, the cases included only patients who received such services locally and not from other districts. Controls were, however, selected from the ordered list for the practice closest in chronological age as the cases. Hence the control group included registered patients who were actually resident in other districts. The inclusion of such patients would seriously underestimate the consultation rates in the control group. The median age of the subjects was 17 years. A significant proportion of the control subjects were in further education and well over a third of the over 18s were in higher education.2 Hence the selection bias is likely to be considerable and could account for the findings in the study. Wai-Ching Leung senior registrar in public health medicine, epidemiology and public health Newcastle General Hospital, Newcastle upon Tyne NE4 6BE
[email protected] Competing interests: None declared.
Severe subglottic stenosis as seen in outpatient clinic (top) and with laryngotracheoscopy (bottom)
1 Churchill D, Allen J, Pringle M, Hippisley-Cox J, Ebdon D, Macpherson M, et al. Consultation patterns and provision
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Letters of contraception in general practice before teenage pregnancy: case-control study. BMJ 2000;321:486-9. (19-26 August.) 2 National Committee of Inquiry into Higher Education. Report. Higher education in the learning society. London: Stationery Office, 1997.
Not all teenagers are sexually active Editor—Churchill et al in their study dispel the myth that teenagers do not consult their general practitioners about contraception.1 They also conclude, however, that teenagers who become pregnant have higher consultation rates than their age matched peers, most of the difference owing to consultation for contraception. We do not believe that this claim is justified, as the potential confounder of sexual activity was not controlled for. While the case group (pregnant teenagers) must be sexually active, the same cannot be said of the age matched controls. It is probable that rates of sexual activity were lower among controls, especially at the lower end of the age range used (13-19 years). In a recent survey only 20% of 13 year olds reported having had full or oral sexual intercourse.2 Abstinent controls would not be expected to consult about contraception. This would lower the average contraceptive consultation rate per individual within the control group, potentially masking higher consultation rates for sexually active controls. Therefore teenagers who become pregnant could be underconsulting for contraception compared with their sexually active peers. On the basis of this paper it cannot be assumed that teenagers who become pregnant make greater use of general practitioners’ contraceptive services. Churchill et al acknowledge in discussion that sexual activity is a confounding variable, but proceed to draw an unjustified conclusion because of their use of inappropriate controls.
P K Josen stage 3 medical student E Low stage 3 medical student K Teare stage 3 medical student E Wray stage 3 medical student Department of Epidemiology and Public Health, Newcastle Medical School, Newcastle upon Tyne NE2 4HH Competing interests: None declared. 1 Churchill D, Allen J, Pringle M, Hippisley-Cox J, Ebdon D, Macpherson M, Bradley S. Consultation patterns and provision of contraception in general practice before teenage pregnancy: case-control study. BMJ 2000;321:486-9. (19-26 August.) 2 Burack R. Teenage sexual behaviour: attitudes towards and declared sexual activity. Br J Fam Plann 1999;24:145-8.
Authors’ reply Editor—Leung seems to have misunderstood our recruitment methods. As we stated in our paper both cases and controls were identified from currently registered patients in the same general practice. Thus they were matched, not only for age, but also for location. Practice computer records, maternity records, and knowledge of practice staff were used solely to identify pregnancy, and not to define prior use of contraceptive or other services. Only general practice based consultations were examined because these could 10 FEBRUARY 2001
Dick Churchill clinical lecturer Jane Allen researcher Mike Pringle professor Julia Hippisley-Cox senior lecturer Division of General Practice, University of Nottingham Medical School, Queen’s Medical Centre, Nottingham NG7 2UH Dave Ebdon lecturer Department of Geography, University of Nottingham, Nottingham NG7 2RD Marion Macpherson consultant Department of Obstetrics and Gynaecology Sue Bradley lecturer School of Nursing
K Duffield stage 3 medical student
[email protected]
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be determined with similar validity among cases and controls. Consultation rates in the control group were therefore not likely to have been underestimated. Leung also raises a concern about the proportion of subjects who might be in higher education. Since, however, most students who were in higher education away from home would be required to register with a general practice near their place of study they would no longer be registered with the study practices and therefore not have been included in the study. We disagree with Duffield et al that we used inappropriate controls, since in a casecontrol design the cases have the outcome (in this case, pregnancy) and the controls do not. We agree that sexual activity is a possible confounder for which it was impossible fully to adjust. This affects the interpretation of our findings but not the findings themselves. Our purpose was, however, to describe use of service and not to determine the appropriateness of such use. We did not conclude that teenagers who become pregnant make greater use of general practice consultations than their sexually active peers. Further research is needed to explore the relation between consultation for contraception and risk of pregnancy in those teenagers who are sexually active.
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Queen’s Medical Centre, Nottingham, NG7 2UH Competing interests: None declared.
Ambition may be best contraception Editor—The paper by Churchill et al on consultation patterns and provisions of contraceptives in general practice before teenage pregnancy and Donovan’s editorial have produced both media and professional debate about teenage pregnancy, sexual activity, and contraception.1 2 This debate has, however, tended to focus on the types of contraception most suitable for use by teenagers and on how information about contraception is given. Although we agree that the consultation process, including issues of confidentiality, is important, contraception itself has never been more easily available, nor in a wider range of options. If young people wish to use proper contraception, it is available. If most young people can have access to illegal drugs, then they are unlikely to have much difficulty with legal ones. Given the emphasis that our society puts on sex, and the force of reproductive biology, the most important issue at present
is what motivates young people not to become pregnant. Because of the “force of reproduction,” girls, and young men who lack ambition in other fields see babies as an option. Blum, at this year’s White House conference on youth in the United States, where teenage pregnancies are also high, reported that those young people who see pregnancy as having a high personal cost for their reputation or their future are much more likely to delay intercourse.3 General practitioners need to make sure they are delivering a good and effective service to young people, teachers need to ensure that health education is properly taught, and parents need to do their bit (with United States research showing that adolescent perceptions of maternal disapproval of sex are associated with delay in first intercourse). Most important, however, is how government and society can make all young people feel that there other worthwhile alternatives to teenage pregnancy. Ambition for young people may well be the best contraceptive. Ann McPherson general practitioner Oxford OX1 2NA Aidan Macfarlane retired consultant in public health medicine Oxford OX1 4LJ Competing interests: None declared. 1 Churchill D, Allen J, Pringle N, Hippisley-Cox J, Ebdon D, McPherson M, et al. Consultation patterns and provision of contraception in general practice before teenage pregnancy: case-control study. BMJ 2000;321:486-9. (19-26 August). 2 Donovan B. Never underestimate the force of reproduction. BMJ 2000;321:461-2. (19-26 August). 3 Blum RW. The White House conference on youth. Society for Adolescent Medicine Newsletter 2000;11:3.
Intrauterine device may not be most suitable method of contraception for teenagers Editor—I agree with Donovan’s editorial regarding effective contraception advice for teenagers requiring a change of medical culture.1 We as medical practitioners must constantly re-examine our own biases and prejudices in order to provide the best possible medical care to all our patients. I disagree, however, with Donovan’s suggestion that the intrauterine device may well be the ideal method of contraception for teenagers at risk of pregnancy because of their difficulty in using the combined pill consistently. The greatest risk of pelvic infection is in the first 20 days after the insertion of the intrauterine device, and is caused by pre-existing carriage of sexually transmitted infections. In most cases adequate preinsertion screening and treatment can ameliorate this risk. The risk thereafter, however, relates to the patient’s background risk of sexually transmitted infections, and teenagers engaging in sporadic, unexpected, or coerced intercourse could hardly be considered to be in a low risk category. Some studies in the United States have found a carriage rate for chlamydia in asymptomatic female teenagers in Seattle of 8.6%.2 Although the progestogen bearing intrauterine device has a theoretical benefit in increasing the viscosity of cervical mucus and thereby possibly 363
Letters preventing ascending pelvic infection, this is as yet not proved. We in the medical profession perhaps need to look “outside the square” when discussing contraception with young people, and that recommending the pill as 99.9% effective is a serious overstatement in teenagers where non-compliance is a real issue. In many countries long acting hormonal contraception is now available, which may provide a possible solution to the compliance issue for many young people using contraception since it does not have to be taken daily. One such option is injectable contraception, either progestogen only or combined. Subdermal progestogen implants also allow for long term and convenient contraception for adolescents without the risks associated with intrauterine devices. Unwanted, unplanned adolescent pregnancy has important social, psychological, and economic effects for a young woman, and for the family, community, and society in which she lives. It would be a pity, however, if in a zealous attempt to prevent such pregnancies we were to recommend contraceptive methods such as the intrauterine device, which might well compromise her ability to achieve a desired pregnancy later in life and increase the ever growing demand for assisted conception services. Terri Foran medical director FPA Health, Sydney, NSW 2131, Australia
[email protected] Competing interests: None declared. 1 Donovan B. Never underestimate the force of reproduction. BMJ 2000;321:461-2. (19-26 August). 2 Marrazzo JM, White CL, Krekeler B, Celum CL, Lafferty WE, Stamm WE, et al. Community- based urine screening for Chlamydia trachomatis with a ligase chain reaction assay. Ann Intern Med 1997;127(9):796-803.
Importance of injecting vaccines into muscle Parenteral vaccines must be given subcutaneously in patients with congenital bleeding disorders Editor—I am surprised that in her editorial on the importance of injecting vaccines into muscle Zuckerman omitted to mention that intramuscular injection is absolutely contraindicated in patients with congenital bleeding disorders.1 Her own institution contains one of the largest haemophilia centres in the United Kingdom, and its advice—as well as that of all other haemophilia centres as far as I am aware—is that in these patients all parenteral vaccines should be given subcutaneously. If this results in a lower rate of successful immunisation then it must be more than offset by the avoidance of the well documented risk of muscle haematoma. J R C Seale haemophilia centre director North West Wales NHS Trust, Ysbyty Gwynedd, Bangor LL57 2PW
[email protected] 1 Zuckerman JN. The importance of injecting vaccines into muscle. BMJ 2000;321:1237-8. (18 November.)
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Author’s reply Editor—My editorial considered the site and administration of vaccines in terms of the general healthy population and not of special high risk groups. It is widely known that patients with coagulation disorders should be given parenteral vaccines by the deep subcutaneous route and not intramuscularly because of the risk of bleeding.1 The immunogenicity and safety of such vaccines given subcutaneously to those with congenital bleeding disorders as well as to other high risk groups are always assessed rigorously so as to ensure that the benefits of immunisation do clearly outweigh any known adverse events.2 Jane N Zuckerman senior lecturer Academic Centre for Travel Medicine and Vaccines, Royal Free and University College Medical School, London NW3 2PF
[email protected] 1 Salisbury DM, Begg NT, eds. Immunisation against infectious disease. London: HMSO, 1996. 2 Zuckerman JN, Moore S, Smith J, Tyrrell H, Baxter A, Lee C. A study to assess the immunogenicity, reactogenicity and safety of hepatitis A vaccine administered subcutaneously to patients with congenital coagulation disorders. Haemophilia 1996;2:235-9.
Evidence is not (yet) enough for evidence based policy for chlamydia screening Editor—Pimenta et al, in their evidence based health policy report, argue that opportunistic screening for Chlamydia trachomatis, targeting young women in primary care, “heralds the approach that is required to manage the wide variety of sexual health issues that confront us today.”1 This conclusion is premature when the pilot studies described are not completed and unanswered questions remain. It is uncertain whether opportunistic screening of young women can control the chlamydia epidemic. The only randomised trial of screening did not evaluate an opportunistic approach and included in the analysis only a small proportion of the women randomised.2 Opportunistic screening in Sweden did reduce rates of infections and complications,3 but recent figures indicate a resurgence among young people. 4 Notification of partners, essential to chlamydia control, is compulsory for general practitioners in Sweden but not in Britain. The pilot studies have yet to report how many eligible women attended clinics and practices during the study period, how many were offered screening, how many were screened, and how many contacts per index case were identified and treated. The ClaSS project (further details at www.chlamydia.ac.uk), funded by the NHS Health Technology Assessment Programme, will make an important contribution to identifying the best approach to screening (figure). For the first time estimates of chlamydial prevalence in both men and women in the general population of Britain, as well as risk factors associated with infection, will be available from a large scale
General population (random sample)
Study of prevalence of chlamydia (18 000 women and men)
Negative
Clinical specimens used to evaluate test
Positive
Case-control study to investigate risk factors (2 controls per case)
Randomised trial comparing notification of partners in general practice with referral to genitourinary clinic
Structure of the chlamydia screening study (ClaSS) in Avon and the West Midlands
study using postal specimens. This will inform the debate about whether men should be screened, an issue not dealt with in the pilot studies. A randomised trial comparing partner notification in general practice with referral to genitourinary clinics will evaluate the most effective way of managing sexual partners. Qualitative research will examine experiences and preferences among people involved in screening and partner notification procedures. Results from these studies and a large linkage study in Sweden will permit cost effectiveness analyses of different screening strategies. In the ClaSS pilot study a response rate of 82% to a request for a urine sample was achieved by using recorded delivery and telephone reminders.5 Targeted postal screening with follow up in general practice or genitourinary clinics may thus be more efficient and cost effective than opportunistic screening; high coverage may be difficult to sustain in the latter once initial enthusiasm has waned and special remuneration has ceased. We hope that decision makers will use a cautious and critical approach that is truly evidence based. Both the pilot studies and the ClaSS project must be carefully evaluated before a decision is taken on whether to implement an opportunistic or a population based screening programme. ClaSS Study Group ClaSS Co-ordinating Centre, Department of Social Medicine, University of Bristol, Bristol BS8 2PR The writing committee members are: Anne McCarthy, CLaSS project manager, Bristol (to whom correspondence should be addressed as above (
[email protected])); Nicola Low, lecturer in epidemiology and public health medicine, Bristol; John Macleod, clinical research fellow, Bristol; Rita Patel, research assistant, Bristol; Anna Graham, clinical research fellow, Bristol; Björn Herrmann, consultant microbiologist, Uppsala, Sweden; Matthias Egger, reader in social medicine and epidemiology, Bristol. The ClaSS collaboration includes the following institutions: Department of Social Medicine, University of Bristol; Division of Primary Care, Department of Medicine, University of Bristol; Department of Primary Care and General Practice, University of Birmingham; Genitourinary Infections Reference Laboratory, PHLS Bristol; PHLS Birmingham; Milne Clinic, United Bristol Healthcare Trust; Whittall Street Clinic, Birmingham Specialist Commu-
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Letters nity Health Trust; Health Services Management Centre, University of Birmingham; Department of Infectious Diseases and Clinical Microbiology University of Uppsala, Sweden. 1 Pimenta J, Catchpole M, Gray M, Hopwood J, Randall S. Screening for genital chlamydial infection. BMJ 2000;321:629-31. (9 September.) 2 Scholes D, Stergachis A, Heidrich F, Andrilla H, Holmes KK, Stamm W. Prevention of pelvic inflammatory disease by screening for cervical chlamydial infection. N Engl J Med 1996;334:1362-6. 3 Egger M, Low N, Smith GD, Lindblom B, Herrmann B. Control of chlamydial infections and the risk of ectopic pregnancy: ecological study. BMJ 1998;316:1776-80. 4 Herrmann B, Egger M. Genital Chlamydia trachomatis infections in Uppsala county, Sweden 1985-1993: declining rates for how much longer? Sex Trans Dis 1995;22:25360. 5 Macleod J, Rowsell R, Horner P, Crowley T, Caul EO, Low N, et al. Postal urine specimens: are they a feasible method for genital chlamydial infection screening? Br J Gen Pract 1999;49:455-58.
Risk factors for breast cancer Smoking may be important Editor—The review by McPherson et al on the epidemiology of and risk factors for breast cancer states that: “Smoking is of no importance in the aetiology of breast cancer.”1 The authors seem to be unaware of the mounting evidence that supports the relation between tobacco smoke and breast cancer. Seven of the eight studies that examined the relation between passive smoking and breast cancer suggest that there is an association between an increased risk of breast cancer and passive long term exposure to smoke among women who have never smoked; this is particularly true in cases of breast cancer occurring before menopause.2–4 Furthermore, when passive smoking was controlled for in these studies, active smoking also seemed to be a risk factor for breast cancer.2 3 Both long term passive smoking among women who have never smoked and active smoking almost double the risk of breast cancer.2 3 Polycyclic aromatic hydrocarbons are found in tobacco smoke, cause mammary cancer in experimental models, and may contribute to the development of breast cancer in humans.5 Given the high prevalence of regular passive smoking and of active smoking among women in most industrialised nations, smoking may turn out to be of considerable importance in the aetiology of breast cancer. Kenneth C Johnson senior epidemiologist Cancer Bureau, Centre for Chronic Disease Prevention and Control, Health Canada, LCDC Building, PL 0601C1, Tunney’s Pasture, Ottawa, ON, Canada K1A 0L2 1 McPherson K, Steel CM, Dixon JM. Breast cancer— epidemiology, risk factors, and genetics. BMJ 2000;321:624-8. (9 September.) 2 Wells AJ. Re: “Breast cancer, cigarette smoking, and passive smoking.” Am J Epidemiol 1998;147:991-2. 3 Johnson KC, Hu J, Mao Y, the Canadian Cancer Registries Epidemiology Research Group. Passive and active smoking and breast cancer risk in Canada 1994-97. Cancer Causes Control 2000;11:211-21. 4 Jee SH, Ohrr H, Kim IS. Effects of husbands’ smoking on the incidence of lung cancer in Korean women. Int J Epidemiol 1999;28:824-8. 5 Rundle A, Tang D, Hibshoosh H, Estabrook A, Schnabel F, Cao W, et al. The relationship between genetic damage from polycyclic aromatic hydrocarbons in breast tissue and breast cancer. Carcinogenesis 2000;21:1281-9.
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Authors’ reply Editor—Recent studies have shown that there is an association between smoking and breast cancer, as Johnson points out, but the association seems to be complex. Certain studies have found an association between smoking and breast cancer, but others have not. For instance, one study suggested that the risk of breast cancer in women younger than 45 is reduced among those who currently smoke and who began smoking at an early age or who have been long term smokers. This contrasts with the findings of other studies that have shown that it is exposure to cigarette smoke when young that is associated with the greatest odds of developing breast cancer.1 2 Earlier studies found that smokers had a lower risk of breast cancer. This finding was confirmed by a recent study from Quebec which reported that smokers had a significantly lower risk of breast cancer, particularly those who smoked cigarettes without filters.3 Other studies have found no significant relation between smoking and breast cancer. The effect of smoking on breast cancer in carriers of the BRCA1 and BRCA2 genes is also interesting: a recent report found that participants with BRCA1 or BRCA2 mutations who had breast cancer were significantly more likely to be non-smokers than participants with the mutations who did not have breast cancer.4 In a multivariate analysis, participants with BRCA1 or BRCA2 mutations who smoked for more than four pack-years (number of packs per day multiplied by the number of years smoked) had a much lower risk of breast cancer (odds ratio 0.46, 95% confidence interval 0.27 to 0.80, P = 0.006). We have also investigated the effects of smoking on breast cancer. In a study of 415 symptomatic women there was a significantly higher rate of lymphatic or vascular invasion in patients who smoked. This is consistent with a recent report that found that patients who had a history of smoking had a lower rate of survival than nonsmokers.5 We accept that there is mounting evidence to support the idea of a relation between tobacco smoke and breast cancer. It has been known for some time that smoking causes damage to the ducts underneath the nipple resulting in periductal mastitis, but the exact relation between smoking and breast cancer seems complex. J M Dixon senior lecturer, surgery Edinburgh Breast Unit, Western General Hospital, Edinburgh EH4 2XU C M Steel professor of medical and biological sciences School of Biological and Medical Sciences, But Medical Building, University of St Andrews, St Andrews, Fife KY16 9TS
[email protected] 1 Lash TL, Aschengrau A. Active and passive cigarette smoking and the occurrence of breast cancer. Am J Epidemiol 1999;149:5-12. 2 Marcus PM, Newman B, Millikan RC, Moorman PG, Baird DD, Qaqish B. The association of adolescent cigarette smoking, alcoholic beverage consumption, environmental tobacco smoke, and ionizing radiation with subsequent breast cancer risk (United States). Cancer Causes Control 2000;11:271-8.
3 Ghadirian P, Lacroix A, Perret C, Maisonneuve P, Boyle P. Sociodemographic characteristics, smoking, medical and family history and breast cancer. Cancer Detect Prev 1998;22:485-94. 4 Brunet JS, Ghadirian P, Rebbeck TR, Lerman C, Garber JE, Tonin PN, et al. Effect of smoking on breast cancer in carriers of mutant BRCA1 or BRCA2 genes. J Natl Cancer Inst 1998;90:761-6. 5 Yu GP, Ostroff JS, Zhang ZF, Tang J, Schantz SP. Smoking history and cancer patient survival: a hospital cancer registry study. Cancer Detect Prev 1997;21:497-509.
Treating bipolar affective disorder ECT is effective Editor—The editorial by Young et al on the treatment of bipolar affective disorder makes no reference to the benefits of electroconvulsive therapy (ECT).1 The authors do a disservice to their patients and to the BMJ’s readers by neglecting to mention ECT and by overstating the benefits of new treatments that have not been tested sufficiently. The merits of ECT in resolving both mania and depression were so well documented by 1940 that they justified its widespread, worldwide acceptance.2 3 A review of literature published over five decades found that 66% of patients went into remission or showed marked clinical improvement of bipolar affective disorders when treated with ECT.4 A retrospective review of patients who had been matched for age, sex, and severity of illness contrasted the efficacy of the therapy in patients with mania with those later treated with chlorpromazine. All of the 28 patients treated with ECT responded to treatment but only 18 of 28 treated with chlorpromazine responded. All 10 patients who had not responded to chlorpromazine were later treated with ECT and all responded, suggesting that ECT is superior. Another study comparing ECT, lithium, and chlorpromazine for treatment of chronic mania found that outcomes were equivalent. A comparison of the efficacy of ECT and lithium over eight weeks in patients with a suboptimal response to lithium alone found that ECT was superior. Patients with mania whose treatment with lithium or neuroleptics was unsuccessful were treated either with ECT or a combination of lithium and haloperidol: 59% had a complete remission with ECT but none who received the combined medication went into remission. The efficacy of ECT in patients with delirious mania is well documented in case reports, and it is often a life saving option. Anticonvulsant agents were introduced into the treatment of mania partly because of their ability to raise seizure thresholds. The efficacy of ECT in raising seizure thresholds is well established. There are no studies comparing ECT with any of the treatments for bipolar disorder recommended in the editorial (anticonvulsant drugs or anticonvulsants with antipsychotic drugs or lithium, or both). Ignoring the benefits of ECT while asserting that other unproved nonpharmacological treatments “are emerging” 365
Letters relies more on hope than on evidence. The efficacy of ECT in relieving bipolar affective disorders has been shown, and its use should be considered in patients with the severe forms of the illness, and those with rapid cycling, delirious mania, and mania that has been resistant to treatment (that is, two adequate trials of medication of no longer than six weeks each have failed). The authors’ call for additional evidence should include studies of ECT. Max Fink emeritus professor of psychiatry and neurology State University of New York at Stony Brook, PO Box 457, St James, NY 11780, USA
[email protected] 1 Young AH, Macritchie KAN, Calabrese JR. Treatment of bipolar affective disorder. BMJ 2000;321:1302-3. (25 November.) 2 Fink M. Electroshock: restoring the mind. New York: Oxford University Press, 1999. 3 Abrams R. Electroconvulsive therapy. 3rd ed. New York: Oxford University Press, 1997. 4 Mukherjee S, Sackeim HA, Schnur DB. Electroconvulsive therapy of acute manic episodes: a review of 50 years’ experience. Am J Psychiatry 1994;151:169-76.
Author’s reply Editor—The points raised by Fink about the effectiveness of electroconvulsive therapy in bipolar disorder are well taken and his letter is a helpful adjunct to our article. Editorials by their nature are brief, and we were asked to focus particularly on pharmacological treatments. New drug treatments are currently creating great interest, but, as Fink reminds us, more research is required on electroconvulsive therapy too. Such research is under way and we would hope to see it reported on the pages of the BMJ at some point. Allan Young professor of psychiatry Department of Psychiatry, Royal Victoria Infirmary, Newcastle upon Tyne NE1 4LP
Advice to authors We prefer to receive all responses electronically, sent either directly to our website or to the editorial office as email or on a disk. Processing your letter will be delayed unless it arrives in an electronic form. We are now posting all direct submissions to our website within 24 hours of receipt and our intention is to post all other electronic submissions there as well. All responses will be eligible for publication in the paper journal. Responses should be under 400 words and relate to articles published in the preceding month. They should include
