Informed consent in medical research. Failure to publish completed randomised controlled trials is...

Informed consent in medical research

Doctors are arrogant to think they needto debate issue of patient consent

Editor—The editorial by Richard Smithraised the issue of publishing studies inwhich the researchers did not seek patients’consent.1 Firstly, I would think that of all theprofessions, only in medicine would there beany sort of debate about whether peopleneed to be told that they, their bodies, theirbody fluids, their emotions, or whatever wereto be subjects of research. This is arroganceon the part of doctors. Has anyone thoughtof asking these “patients” what theiropinions are?

Secondly, I also think that doctors indeveloping countries need to be especiallycareful about obtaining consent frompatients for anything, not only research.I would like to know that when I read apaper from a developing country in theBMJ, I can be sure that the individuals onwhom the research was done had giveninformed consent.David E Bratt Paediatrician5 La Croix Avenue, Diego Martin, Trinidad andTobago, West Indies

1 Smith R. Informed consent: the intricacies. BMJ1997;314:1059-60. (12 April.)

No one has a monopoly on deciding whatis ethical

Editor—Having just come to the end of myterm as chairman of our local research eth-ics committee, I would like to contribute tothe debate on informed consent.

I have no doubt that informed consentshould be obtained in virtually all researchstudies. The difficulty comes in those rareinstances when the need to obtain informedconsent may be waived. Len Doyal has madea thoughtful and useful contribution to thedebate,1 but it is interesting that, whereas Iwould have said that the study by SatishBhagwanjee and colleagues qualified underhis suggestions,2 he seems to imply that itwould not.

The commentaries of Rajendra Kaleand Sheila McLean were critical of the twostudies published in the BMJ, 2 3 but theyfailed to address the specific issues raised bythe trials and resorted instead to vague gen-eralisations. Neither was prepared to con-sider seriously the harm that can be done bynot performing trials from which bias hasbeen excluded as far as possible.4 In contrast,Martin Dennis and Bhagwanjee and col-leagues, who defended their decision not to

obtain informed consent, wrote clearlyabout the different issues entailed and hadobviously agonised about the problem.2 3 Ibelieve that it was perfectly reasonable inboth studies not to obtain informed consent.In neither case was there any possibility ofharming the participants and importantinformation for the care of future patientswas obtained. I do not subscribe to the viewthat not seeking informed consent indicatesa failure to respect the subjects in thesestudies. Indeed, the care with which theissues were considered before starting thestudies and the safeguards that were put inplace indicate that the reverse was true.

Richard Smith asked whether the BMJshould publish papers describing studies inwhich informed consent was not obtained.4

There is clearly so much disagreementabout the situations in which such trialsmight be conducted that it would be wrongfor the BMJ to decline to publish the resultsof these studies if they have been given theapproval of properly constituted researchethics committees. No one can claim to havea monopoly on deciding what is ethical. Bypublishing such trials the BMJ will provideimportant material showing what differentresearch ethics committees think. These datamay then inform the continuing debate withthe decisions taken by a wide range ofconcerned individuals, dealing with real lifeissues.Pat Soutter Past chairman, research ethics committeeHammersmith Hospitals NHS Trust, LondonW12 0NW

1 Doyal L. Journals should not publish research to whichpatients have not given fully informed consent—with threeexceptions. BMJ 1997;314:1107-11. (12 April.)

2 Bhagwanjee S, Muckart DJJ, Jeena PM, Moodley P. DoesHIV status influence the outcome of patients admitted to asurgical intensive care unit? A prospective double blindstudy (with commentaries by R Kale, S Bhagwanjee et al,and YK Seedat). BMJ 1997;314:1077-84. (12 April.)

3 Dennis M, O’Rourke S, Slattery J, Staniforth T, Warlow C.Evaluation of a stroke family care worker: results of a ran-domised controlled trial. BMJ 1997;314:1071-7. (12 April.)

4 Tobias JS. BMJ’s present policy (sometimes approvingresearch in which patients have not given fully informedconsent) is wholly correct. BMJ 1997;314:1111-4.(12 April.)


Let readers judge for themselves

Editor—I am a medical statistician, not adoctor, so my experience is rather remotefrom the patient. I think there are two issueshere: Is it ever right to randomise peoplewithout their consent? Is it ever right to treator measure people without their consent? Ithink it can be right to randomise people

without their consent when randomisationis to what the person would have received inthe absence of the trial. Thus the strokeworker study seems defensible.1 I did such astudy—the “Know your midwife” study—inwhich the lead researcher, very committedto the scheme, thought that no woman whoknew of the scheme would accept anythingelse.2 Women were randomised to be offeredthe continuity of a midwifery care regimenand then offered a choice of that regimen orstandard care. Others were offered standardcare only. All were asked to consent to astudy of events around birth and inter-viewed. I thought this was all right and stilldo. Sometimes we randomise people bygeneral practice. I don’t think we could getconsent to randomisation. However, we canstill obtain consent to treatment.

I think it is rarely acceptable to treat aperson without consent. But consider apatient who is unconscious after an over-dose. Should we revive the patient? Thepatient’s action suggests that consent is notgiven, but I think we might do it anyway. Ihave recently discussed a trial of differentmethods of treatment for these cases. I thinkmy conclusion would have to be that if it isethical outside a trial it would be ethicalinside a trial, too. However, the Durban

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1477BMJ VOLUME 314 17 MAY 1997

patients were mostly able to consent, as theHIV test could presumably have been doneafterwards with stored blood.3 I think thatstudy was unethical.

I think it is dangerous to let one moralprinciple—informed consent—become abso-lute. Hence I would not banish all suchresearch from the BMJ and only if the editorthought the work indefensible would I keepit out. If the issue was debatable I think Iwould publish the paper, though I wouldexpect authors to justify their actions.Readers could then judge for themselves.

Thanks for a stimulating issue.Martin Bland Professor of medical statisticsSt George’s Hospital Medical School, LondonSW17 0RE

1 Dennis M, O’Rourke S, Slattery J, Staniforth T, Warlow C.Evaluation of a stroke family care worker: results of a ran-domised controlled trial (with commentaries by S McLean,M Dennis). BMJ 1997;314:1071-6. (12 April.)

2 Flint C, Poulengeris P, Grant A. The “Know your midwife”scheme—a randomised trial of continuity of care by a teamof midwives. Midwifery 1989;5:11-6.

3 Bhagwanjee S, Muckart DJJ, Jeena PM, Moodley P. DoesHIV status influence the outcome of patients admitted to asurgical intensive care unit? A prospective double blindstudy (with commentaries by R Kale, S Bhagwanjee et al,and Y K Seedat). BMJ 1997;314:1077-81. (12 April.)

Ethics committees and the BMJ shouldcontinue to consider the overall benefit topatients

Editor—We support Martin Dennis in hiscommentary to his and his colleagues’ paperthat the decision to fully or partially informconsent should take into account the likelyeffect on important outcome measures, aswell as the benefit of good research for allpatients.1

We made the difficult decision—inconsultation with local ethics committees—that patients attending their generalpractitioner with sore throat should beasked to consent to the procedures and tothe aim of assessing the natural history, butin trying to “mimic” normal practice, doctorswere encouraged not to discuss the ran-domisation to one of three approaches incommon clinical use: antibiotics, no anti-biotics, or the offer of delayed antibiotics.2

Randomisation to the three approachesreplaced the normal bias or preference ofthe general practitioner, which the patient isalso uninformed about.

We showed that prescribing antibioticsmedicalises sore throat and increases inten-tion to consult. We believe that a full discus-sion of the educational purpose of theresearch, and of the different managementgroups—which must be rare in normalpractice—would have significantly biased theresults so that groups would have beenmuch more similar. High prescribers wouldthen see no benefit from changing their pre-scribing, with encouragement to waste the£60m-120m of NHS money spent annuallyon sore throat, with disbenefit to all futurepatients. Similar arguments apply to fullyinforming the control group of many otherimportant open studies—for example, effectof leaflets on stopping smoking and theOxcheck study. The technical breach ofautonomy—to give complete informationfor some patients on one occasion—has to

be seen in the context of deviancy from rou-tine practice and judged against breachingthe same principle the next time the samepatient sees their doctor—that is, not beingable to inform the patient fully of correctmanagement, as well as the beneficence tomany more patients. This utilitarian argu-ment was made by Len Doyal in condoningthe use of medical records,3 and there is noclear justification of why the ethical issuesfor randomised trials should be different.

Adopting an absolute ethical view inopen trials ignores the realities of—andwould undermine the ability of research toinform—normal practice and thus couldultimately harm patients, including thosewho agree to take part in trials. The BMJ andethics committees should continue to judgethe overall benefit for patients.Paul Little Wellcome training fellowIan Williamson Senior lecturerUniversity of Southampton, Primary Medical Care,Aldermoor Health Centre, Southampton SO16 5ST

1 Dennis M, O’Rourke S, Slattery J, Staniford T, Warlow C.Evaluation of a stroke family care worker: results of a ran-domised controlled trial (with commentaries by S McLean,M Dennis). BMJ 1997;314:1071-7. (12 April.)

2 Little P, Williamson I, Warner G, Gould C, Gantley M,Kinmonth AL. Open randomised trial of prescribingstrategies for sore throat. BMJ 1997;314:722-27. (8 March.)


Risk of bias may be another reason not toseek consent

Editor—Reading through the various arti-cles in the 12 April issue has confirmed theview I already held that there are situations inwhich informed consent is more trouble thanit is worth. Consequently, I am of the view thatthe BMJ was right to publish the papers inquestion and would be wrong to impose aban on publishing such papers in future.

The rights of individual patients must, ofcourse, be protected, but not to theexclusion of all other considerations; peoplehave obligations as well as rights. I considerit sufficient that a study is approved by anethics committee. If the members can beconvinced that the study remains ethicalwithout informed consent, then the papershould be considered for publication. Itwould be unethical not to publish a soundand valuable piece of work, thus denyinguseful knowledge to the medical communitysimply because informed consent was notsought. Presumably the lobby in favour ofthe ban hopes that such studies would notthen be done. This I doubt.

I think any policy adopted by the BMJon this issue should be framed in terms ofethics committee approval. If the BMJdecides to follow a policy along the linesproposed by Doyal1 I would like to see atleast one other category of exception—thatis, where there is a perceived risk thatseeking informed consent might bias theconclusions of the study (as in the strokefamily care worker study2 and the breastcancer study of McArdle et al 3).

As another example, suppose onewished to set up a study comparing methodsof persuading pregnant women to stop

smoking during pregnancy. If you tell thepatient that you are going to try to stop herfrom smoking either by not haranguing heror by haranguing her frequently herultimate behaviour might be influenced bythis knowledge. This is a testable hypothesis.It would be possible to set up such a study asa two by two factorial in which one of thetreatment factors was informed consent andthe other was whatever intervention treat-ment was of interest. The presence of aninteraction between the two factors wouldsupport the hypothesis. I am not aware thatsuch a study has ever been done, but it wouldhelp to settle the question of whetherseeking informed consent can bias theresults of a study. If the BMJ had alreadyimplemented a ban on publishing paperswithout informed consent how would theresults of such a study see the light of day?

Finally, I applaud the BMJ’s decision toopen this issue to wider debate and seek thereadership’s views. I hope it generates alively response.Dennis O Chanter Principal consultant statisticianBRI International, Battle, East Sussex TN33 0TX

1 Doyal L. Journals should not publish research to whichpatients have not given fully informed consent—with threeexceptions. BMJ 1997:314:1107-11. (12 April.)

2 Dennis M, O’Rourke S, Slattery J, Staniforth T, Warlow C.Evaluation of a stroke family care worker: results of a ran-domised controlled trial (with commentaries by S McLean,M Dennis). BMJ 1997;314:1071-6. (12 April.)

3 McArdle JMC, George WD, McArdle CS, Smith DC,Moodie AR, Mark AV, et al. Psychological support forpatients undergoing breast cancer surgery: a randomisedstudy. BMJ 1996;312:813-7.

Clinicians are being disingenuous withthemselves

Editor—I would like to raise a concernabout the relation between the ethics ofmedical research and the ethics of clinicalmedicine. Clinicians play a lead role in thegreat majority of medical research projectsand the framework within which theypractice medicine plays a part in their judg-ment of the ethics of their research.Although the principle of informed consentis widely accepted, the actuality may bedifferent, as illustrated by Ganapati Mudur’sreport of the condemnation by ethicists of astudy in India of the clinical course of cervi-cal dysplasia.1 The study is necessarybecause the available evidence is insufficientto quantify the risks of dysplasia, and showsthat cervical dysplasia normally resolvesspontaneously rather than progressing tocancer. A gynaecologist objecting to thestudy argued that it was unethical because“the investigators had not informed thestudy participants that their lesions wereknown to progress to cancer.”1 Whileclinicians are being disingenuous withthemselves it is hard to see how they can betruly honest with their patients.

In Britain, thousands of women receivetreatment for cervical dysplasia each year,believing that it is saving them from cancer,when the chances are that they have beensubjected to an unnecessary intervention.This suggests that they are being treated onfalse pretenses rather than on the basis ofinformed consent.

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If, as proposed, the BMJ and other jour-nals refused to publish the results of studiesin which informed consent had beenobtained,2 the problem of not obtaininginformed consent in research would eventu-ally be solved—but though researcherswould be learning the lesson the hard way,this would abuse the time, energy, and good-will of patients who had volunteered to par-ticipate in studies without informed consent,on the grounds that their participationwould benefit humankind. If the realproblem is informed consent in clinicalpractice, making researchers do things theright way won’t solve it.

It is excellent that the editorial board ofthe BMJ is concerned to tackle this problemand is opening the debate on the way toproceed. Ensuring that those who have beenabused by the present system are given apublic voice, as in the anonymous personalview,3 might be a more ethical way toproceed than a blanket ban on publicationof the results of some studies.Sarah Stewart-Brown DirectorHealth Services Research Unit, Department ofPublic Health, University of Oxford, OxfordOX3 7LF

1 Mudur G. Indian study of women with cervical lesionscalled unethical. BMJ 1997;314:1065. (12 April.)

2 Smith R. Informed consent: the intricacies. BMJ 1997;314:1059. (12 April.)

3 Anonymous. All treatment and trials must have informedconsent. BMJ 1997;314:1134-5. (12 April.)

We all have a responsibility to contributeto research

Editor—Jeffrey S Tobias identified anatmosphere of mistrust by patients towardsclinical trials.1 Perhaps we can begin toreverse this atmosphere by involving thosegroups of thoughtful bystanders who wereround the outside of the arena2 but havenow been encouraged to clamber in to jointhe combat.3 Collaboration is the name ofthe game. Research is for the benefit of usall: all should be involved in debates aboutits improvement and promotion.

The Consumers’ Advisory Group forClinical Trials, a distinctive working group ofprofessionals and patients, sees the need topromote a new image of research as anongoing process of extreme importance. Itworks directly with the professions, helpingto develop their protocols and to preparetheir information leaflets for patients. Thegroup identifies an urgent need to advancepublic education about clinical trials. Con-cepts such as randomisation, risk percep-tion, and probability are poorly understood.Educating members of the public when theyare well,4 identifying the importance oflanguage, and educating children and medi-cal students about research concepts are allstrategies that would widen appreciation ofthe need for research while balancing theseresponsibilities with the right to informedconsent, as and when it is appropriate to theparticular study.5

Such cooperation, shared responsibility,and greater understanding of research con-cepts will create a different attitude toresearch, which will be seen not as an

imposition but as an activity to which we allhave a responsibility to contribute.Hazel Thornton Chairwoman, Consumers’ AdvisoryGroup for Clinical Trials31 Regent Street, Rowhedge, Colchester CO5 7EA


2 Thornton HM. Breast cancer trials: a patient’s viewpoint.Lancet. 1992;339;44-5.

3 Baum M. The ethics of randomised controlled trials. Eur JSurg Oncol 1995;21:136-9.

4 Thornton H. A “ladyplan” for trial recruitment? Everyone’sbusiness! Lancet 1993;341:796.

5 Thornton H. What can patients contribute to the design ofclinical trials? In: Tobias J, Houghton J, eds. New horizons inbreast cancer: current controversies, future directions. London:Chapman and Hall (in press).

Minimum ethical standards should notvary among countries

Editor—I am glad that you have openeddiscussion on the important issue ofinformed consent in medical research, andin such a comprehensive way.1 I haverecently been teaching research methods indifferent countries. The courses alwaysinclude a session on ethics in research(including qualitative research—sometimesthought not to need informed consent).Many developing countries, including someAsian countries, have not yet establishedresearch ethics committees, although thereare individuals keen for this to happen.However, in one country, where members ofthe medical profession tend to be part of asmall elite, some course participants said ina discussion on informed consent: “But if weask the subjects they might say no.”

I agree that there is a danger thatresearchers from developed countries mayundertake certain studies in developingcountries where they may believe, or argue,that ethical issues are different. I have heardthe argument that informed consent byindividuals is not required or appropriatewhere people tend to have a “group” ratherthan an “individual” identity, that it issufficient to obtain consent from, forexample, a village chief. I am wary of sucharguments. By all means get consent fromthe chief, but also from every individualconcerned. Although cultural differencesneed to be taken into account in ensuringthat a study is carried out in a sensitive andethical way, minimum ethical standardsshould not vary among countries.

Although Satish Bhagwanjee and col-leagues clearly considered the ethical issueswith great care in their study on HIV status,2

I think that you should not publish suchstudies. But editorials that remind readers ofthis policy from time to time, and the reasonfor it, would be very helpful. A series of arti-cles in simple language on different ethicalissues, such as informed consent, privacy,ownership of data, community involvement,dissemination of data, responsibility forpublicity, etc (including how to establish aninstitutional ethics committee) would beinteresting and valuable.Wendy Holmes LecturerInternational Health Programs, Key Centre forWomen’s Health, University of Melbourne, 211Grattan Street, Carlton, Victoria 3053, Australia

1 Informed consent: the intricacies. BMJ 1997;314:1059-60.(12 April.)


South African study raises the ghosts ofNuremberg and apartheid

Editor—I am astonished that the BMJshould publish the findings of a researchstudy that failed to seek the consent of thepatients.1 In particular by tacitly condoningthis most unethical practice from a group ofresearchers from South Africa, the BMJ hasmissed an opportunity to teach them howthe civilised world outside the confines ofapartheid treats its patients. The BMJ alsolost the opportunity to show its local editionpartners all over the democratic and emerg-ing democratic world how to stand up forethics and human rights even in the face ofextreme pressure from prospective authors(big and influential) who fail to observeaccepted ethical practice.

Even before the Nuremberg code wasdesigned in 19472 and then reasserted by theHelsinki declaration of 19643, the inviolabil-ity of the right of patients to an unambiguousand informed consent in all forms of experi-mentation was already standard practice. In1898 Albert Neisser, the discoverer of thegonococcus and a pre-eminent professor ofhis generation, was prosecuted and fined forconducting experiments with prostituteswithout their consent. The disciplinary courtbased its judgment not on questionablescience but on the lack of patients’ consent. Italso concluded that intervention withoutconsent fulfilled the criteria for causingphysical injury in criminal law.4

Bhagwanjee and colleagues state thattheir study was deemed to be of sufficientimportance to waive patients’ right toinformed consent. The Helsinki declarationprohibits absolutely any human experimen-tation in dying patients because it recognisesthat respect for the rights of patients has thesame importance for the good of mankindas medical and scientific progress. Wouldany ethics committee in the United King-dom, the home of the BMJ, approve a studywithout patients’ consent? How many of theSouth African study victims were black menand women? And considering the recentexperience of that country during the apart-heid years, how many of such unethicalpractices were condoned? Who compen-sates for the injury that these human guineapigs suffer? This study raises the ghosts ofNuremberg and apartheid, and it is a bigshame that the BMJ should indirectlyencourage it. There is no point in closing thestable door after the horse has escaped.5 Inthis case why publish the paper beforeasking readers for their views on the issue ofinformed consent in research? I fail to seewhat new ground this study was going tobreak for mankind and even then thepatient’s right to give or withhold consentmust not be violated.Joseph N E Ana Private practitionerLuton LU3 1PB

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2 The Nuremberg code (1947). BMJ 1996;313:1448.(7 December.)

3 Declaration of Helsinki. BMJ 1996;313:1448. (7 December.)4 Vollmann J, Winau R. Informed consent in human experi-

mentation before the Nuremberg code. BMJ 1996;313:1445-7. (7 December.)

5 Smith R. Informed consent: the intricacies. BMJ 1997;314:1059-60. (12 April.)

Consent is not always practical inemergency treatments

Editor—Richard Smith asks for readers’views on whether papers should be pub-lished only if there has been informedconsent for the study.1

I agree completely that for the vastmajority of clinical research the patientshould be fully informed about all aspects ofthe trial or study and their consent freelyand willingly obtained. However, there areoccasions when this is not practical. In themain, these are clinical trials related toemergency treatment. Some aspects of careof newborn infants at birth have not beenproperly investigated and badly need datafrom good randomised trials—for example,the treatment of meconium aspiration.When meconium aspiration has occurredthere is no time to ask for consent to a trialand it is rarely possible to predict theproblem and ask for consent beforehand.Even with warning signs the mother is not ina position to give fully informed consent; thefather may not be present, and even if he ishe will be worried by what is happening tohis wife and child so that it is inappropriateto try to inform him about a randomisedtrial and ask for his consent. There areseveral possible solutions to this problem,although none are ideal.

(1) Inform every woman entering thematernity hospital about the trial and ask forconsent if her baby has meconium aspira-tion. However, to obtain such blanketconsent in a busy delivery unit would be dif-ficult and probably inappropriate as meco-nium aspiration occurs in a small proportionof babies. Consent would not be obtainedfrom a woman with an acute problem onadmission and the baby would not beenrolled. This will bias the trial because suchbabies would be likely subjects for the trial.

(2) Enrol only babies for whom consentcould be obtained from the parents. This ispossible, but it is likely to result in a biasedtrial because the most difficult acute caseswill not be enrolled and therefore the babieswill not represent the full clinical spectrum.

(3) Conduct a trial with the approval ofa professional peer group and the hospitalethics committee that asks for consent whenpossible, but if this is not possible because ofthe nature of the emergency the patient isallowed to be enrolled in the trial. Theparents would be informed and asked fortheir consent as soon as possible, allowingthem to withdraw from the trial if they wish.

(4) Not do a randomised trial andcontinue to use the unproved treatment.

None of these solutions is ideal and allhave ethical problems. The question is which

technique is the most ethical? I suggest thatthe least unethical solution is to conduct agood, well planned, vetted, and approvedtrial even if previous consent cannot beobtained in all cases and then inform thepatients, or in this case parents, afterwards. Ifsuch trials are refused publication it willimpede research in emergency proceduresand those that are published will be unsatis-factory because they will not represent thefull range of patients.Colin Morley Clinical directorNeonatal Intensive Care Unit, AddenbrookesHospital, Hospital Box 226, Cambridge CB2 2QQ


Children from the age of 5 should bepresumed competent

Editor—When considering informed con-sent in medical research Len Doyal statesthat one of the three circumstances in whichresearch should be allowed to proceed inthe absence of informed consent is whensubjects are not competent to give consent.1

One group given as an example was that ofyoung and immature children. Before thisstatement is accepted the terms young andimmature have to be defined.

Alderson and Montgomery argue thatchildren can and should play a greater partin decisions about their own health care.2

They recommend that any child who canexpress a view should be given information,listened to, and have his or her views takeninto account when decisions about treat-ment are being considered. Their sugges-tions for a statutory description of capacitywould be present when a child understandsthe type and purpose of the proposed treat-ment, the nature and effects of the treatmentin broad terms, the principal benefits andrisks, and the consequences of not receivingtreatment and when he or she has thecapacity to choose whether to accept thetreatment. When children are competent totake responsibility for a decision the respon-sibility for that decision would becometheirs.

They argue that young people from theage of 5—that is, of compulsory school age—should be presumed competent. The youngage was chosen as the presumption does notexclude parents from discussion. It alsoencourages recognition that young childrenmay be competent to make certaindecisions—for example, whether to takemore analgesics, if not more complexones—and allows for the children to bedeemed not competent and for theirdecisions to be overruled, especially if theirdecision would result in serious irreparableharm to their health. Perhaps these criteriacould be used as a basis for discussion whenconsidering how to assess children andyoung people’s competence to consent toparticipation in research. This would be inline with Doyal’s additional statement that“the levels of autonomy that patients whoare thus incompetent do possess should stillbe respected (for example, if they resist par-ticipation then it should not be forced).” 1

A third point is that, just as in adults,competence in children is not somethingwhich is merely present or absent. Itspresence may vary in children of the sameage, depending on when, where, and howthe question is asked, the cognitive capaci-ties of the child at that time, and the level ofcompetence3 required—for example, themere ability to assent or a full understandingof the decision and the possible conse-quences for the individual.Moli Paul Senior registrar in child and adolescentpsychiatryParkview Clinic, Birmingham B13 3QE


2 Alderson P, Montgomery J. Health care choices: making deci-sions with children. London: Institute for Public PolicyResearch, 1996.

3 Appelbaum PS, Grisso T. Assessing patients’ capacities toconsent to treatment. N Engl J Med 1988;319:1635.

Research in patients with mentalretardation poses special problems

Editor—In response to the editorial byRichard Smith and the articles on informedconsent in biomedical research by LenDoyal and Jeffrey S Tobias,1-3 I suggest thatthe issues surrounding incompetent patientsas in cases of mental illness or mental retar-dation are particularly important. Peoplewith mental retardation warrant specificmention, especially because those withsevere degrees of disability will never be ableto exercise their right to autonomousdecision making. Yet, they as patients havethe most intensive needs and have increasedrates of challenging behaviour or mental ill-ness, or both, and the treatments for theseconditions remain symptomatic and haveprobably been investigated (originally) onlyin normal subjects.

The advent of community care for thispopulation and the emphasis on social care4

has created a resistance to research carriedout in children and adults with learningdisabilities, further aided by the ever presentand gruesome memories of the eugenicsmovement in the early 20th century and theNazi experiments. However, time and again,clinicians are faced with intractable disor-ders in their patients with learningdisabilities which compromise the patient’squality of life, may be extremely stressful tomanage and cope with, and may put otherresidents and staff at risk. In addition, selfinjurious behaviour may be extremelysevere, thus compounding the effects of thedisability. Research on the pharmacologicaltreatment of developmental disorders hasbeen mainly based on small scale studieswith inadequate methodology—that is, theuse of antipsychotics/antidepressants andopioid antagonists in severe and unremit-ting aggression and self injurious behaviour.Evidence is still scant on the advantages anddisadvantages of the different types of drugsfor controlling challenging behaviour, withserious financial and clinical practice impli-cations. It is a pity that the recent advances inmedical technology and non-invasive proce-dures and improved understanding of theinteraction between brain function and

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1480 BMJ VOLUME 314 17 MAY 1997

environment, which could yield importantresults for patients with learning disabilities,are not used to their full potential. Doyal’sguidelines2 certainly go some way towardsaddressing the issue of consent with incom-petent patients, although more work, such ascanvassing views of service users and carersand promoting advocacy for this clientgroup, will be necessary before the stigma ofunethical research stops beneficial treat-ments from being used.A Hassiotis Honorary senior lecturer in developmentaldisorders and learning disabilityDepartment of Psychiatry and BehaviouralSciences, University College London MedicalSchool, London W1N 8AA




4 Neuroscience Approach to Human Health InitiativeSteering Committee. Mental handicap research: new technolo-gies and approaches. Report of the workshop organised under theinitiative of the Neuroscience Approach to Human HealthInitiative Steering Committee. Warwick: University ofWarwick, 1993.

Studies with important conclusions butwithout patient consent should bepublished

Editor—Your debate on informed patientconsent for medical research this weekmade fascinating reading, and the situationswhere informed consent is, and is not,appropriate were comprehensively dis-cussed by Len Doyal and Jeffrey S Tobias. 1 2

That a study is methodologically soundso that meaningful conclusions can bedrawn is of paramount importance and isthe greatest problem we face in medicalresearch. While those authors who havespent time and effort in designing a studyadequate to produce a sound paper willprobably also have obtained informedconsent in appropriate cases, this will not bea perfect correlation, partly because of vary-ing interpretations of what constitutes anappropriate case. An occasional paper willtherefore emerge with valid and importantconclusions, but no patient consent. Aprohibition on publication of papers with-out patient consent would cause valuableinformation to be absent from the literature,a scientifically and morally unacceptablesituation. Each paper should be judged onits merits, with the appropriate presence ofinformed consent representing an impor-tant, but not paramount, consideration.

The BMJ ’s present policy of sometimespublishing research in which patients havenot given fully informed consent is indeedwholly correct.Mark F G Hulbert Senior registrar in ophthalmologyMoorfields Eye Hospital, London EC1V 2PD


2 Tobias J. BMJ ’s present policy (sometimes approvingresearch in which patients have not given fully informedconsent) is wholly correct. BMJ 1997;314:1111-4.(12 April.)

Failure to publish completed randomisedcontrolled trials is unethical in itself

Editor—In response to Richard Smith’srequest for help in deciding the BMJ’s policyon informed consent,1 we would arguestrongly in favour of maintaining thejournal’s present position. Nobody wishes topromote unethical research, but failure topublish completed randomised controlledtrials is unethical in its own right: the effortsof all those who participated in the trial arewasted, and both health professionals andpatients are deprived of information thatthey may need to make informed decisions.2

There is a good deal of hypocrisy in clini-cal medicine about informed consent. Manyso called established treatments have beenpoorly evaluated so that their true benefitsand risks remain unclear. These treatmentsshould still be regarded as experimental andyet, because they are accepted, they are widelygiven without any form of consent beingrequired. For example, many treatments arewidely used in different countries to treatpatients with acute stroke—for example, aspi-rin, heparin, glycerol, haemodilution, corti-costeroids, ancrod3 4 —but none of these havedefinitely been shown to reduce the risk ofdeath or disability and many could be harm-ing patients—for example, antithromboticagents could increase the risk of intracranialhaemorrhage.5 Many more patients areexposed to this abuse of consent than in ran-domised controlled trials but this is rarelyquestioned. Hardening of the already strin-gent requirements for informed consent inrandomised controlled trials will lead to fewerand smaller randomised trials and continueduncertainty over the risks and benefits ofmany treatments and hence to continuedwidescale abuse of patients’ consent in clinicalpractice.Carl E Counsell* Clinical research fellowPeter A G Sandercock* Reader in neurologyDepartment of Clinical Neurosciences, WesternGeneral Hospital, Edinburgh EH4 2XU

*Peter A G Sandercock is the principal investiga-tor in the international stroke trial (a randomisedtrial of aspirin and heparin in 20 000 patientswith acute stroke) and both authors aremembers of the Cochrane Stroke Group and ofthe same department as Martin Dennis et al,whose randomised controlled trial evaluatingstroke family workers was published in the 12April issue of the BMJ (pp1071-7).


2 Chalmers I. Underreporting research is scientific miscon-duct. JAMA 1990;263:1405-8.

3 Lindley RI, Amayo EO, Marshall J, Sandercock PAG,Dennis M, Warlow CP. Acute stroke treatment in UK hos-pitals: the Stroke Association survey of consultant opinion.J R Coll Physicians Lond 1995;29:479-84.

4 Ricci S, Celani MG, Righetti E, Cantisani AT for the Inter-national Stroke Trial Collaborative Group. Between coun-try variations in the use of medical treatments for acutestroke: an update [abstract]. Cerebrovascular Diseases1996;6(suppl 2):133.

5 Warlow C, Van Gijn J, Sandercock P, eds. Stroke module of theCochrane database of systematic reviews [updated 4 March1997]. Oxford: Update Software, 1997. (Updated quarterly.)

Subjects may be coerced intoparticipating in studies

Editor—Whether prospective research withno explicit statement about informed con-sent should be published is an issue avoided

by journals for too long.1 Subjects in someexperiments believe that they are receivingstandard treatment when there is noevidence of utility.2-4 Recently I reviewed aprospective multicentre study of myocardialinfarction in which the end points includeddeath. There was no statement about ethicsapproval or informed consent. I suggestedthat if this was not an oversight the journal“would have to decide whether it wants topublish an unethical trial.”

When subjects give informed consentthe experiments may still be unethical ifconsent is not given freely. Subjects may becoerced by poverty into participation or findit difficult to refuse a request from anemployer, colleague, or teacher. I am awareof recent research involving military staffwho were ordered to volunteer.

I have particular concerns aboutresearch in diving medicine. Most isperformed outside hospitals and without thesafeguard of hospital ethics committees. InDiver magazine I reported that volume 9 ofUndersea and Hyperbaric Physiology contained111 scientific papers, of which 47 describedhuman research.5 Twelve studies were onpatients and 35 on so called volunteers, whowere often military staff or employees of thecommercial diving organisations that con-ducted the research. Only seven papersmentioned that ethics approval was grantedand only 12 mentioned informed consent.Some experiments were highly hazardousand might be best described as adventures insurvival for the participants. Many studiesfailed to mention adverse effects. When theydid, it was evident that at least 38 of the socalled volunteers had decompression illnessin studies which were often too small orincorrectly designed to give a statisticallyvalid result.

Senior institutions are not abovereproach. Eight years ago the MedicalResearch Council Decompression SicknessPanel proposed introducing “professionaldiver super medicals.” Like the currentmedical assessments, the super medicalswould be performed at intervals during adiver’s career but would include additionalexpensive investigations such as radionu-clide scanning. The results were to be usedin a prospective survey of long term healthhazards of diving, but the divers were to betold that it was for individual screening andthat they would be asked to pay for theinvestigations. Those who refused wouldlose their licence and livelihood. The planwas abandoned only recently, though I andothers expressed concerns about the ethicswhen it was first proposed.Peter Wilmshurst Consultant cardiologistRoyal Shrewsbury Hospital, Shrewsbury SY3 8XQ


2 Adkisson GH, Macleod MA, Hodgson M, Sykes JJW, SmithF, Strack C, et al. Cerebral perfusion deficits in dysbaric ill-ness. Lancet 1989;ii:119-22.

3 Wilmshurst PT, Nunan TO. Cerebral perfusion deficits indysbaric illness. Lancet 1989;ii:674-5.

4 Adkisson GH. Cerebral perfusion deficits in dysbaricillness. Lancet 1989;ii:675.

5 Wilmshurst P. Ethical or not? Diver 1992;37(9):85.

Letters


The whole population must be mobilisedin the war against cancer

Editor—Ethicists should carefully avoidabsolutism lest they become hostages to for-tune. Len Doyal, an ethicist whom I muchadmire, has fallen into this trap.1 Forexample, he states and restates his belief thatit is unacceptable to compromise individualrights, even if the public interest demands it.I presume therefore that he is too young toremember the conscription that was neces-sary to fight a just war against the Nazi pow-ers: the very ones guilty of the worstatrocities committed in the name of medicalscience.

Cancer commits atrocities on thehuman body, and the fight against cancerhas often been likened to a war: “The waragainst disease and for health cannot befought by physicians alone it is a people’swar in which the entire population must bemoblised permanently.”2 If there is to be awar against cancer and if it is consideredunethical to conscript patients as the footsoldiers in this war, then it is up to the laypublic to recognise their responsibilities tosociety on a voluntary basis, in addition todemanding their rights of autonomy andprogress for the treatment of malignant dis-ease. It was precisely that argument that Idescribed in my paper in the Lancet in 1993,3

which was inappropriately cited by Doyal tosupport his argument about access to medi-cal records.

I am glad to report that many womenwith breast cancer have risen to thischallenge,3 4 and we now have a consumer’sadvisory group of committed lay womenchaired by Hazel Thornton who seethemselves as equal stakeholders in the fightagainst cancer. Until we have permanentlymobilised the whole population in this warthe agonising debate about the process andethics of informed consent will continue tothunder on and on. In the meantime, in aless than perfect world I have to side withJeffrey S Tobias, who like me, every day of hisworking life, has to make these toughdecisions.5 It would help the debate if thearmchair ethicists got down from theirverandas and mixed with the natives—perhaps first hand experience would dilutetheir uncompromising zeal.Michael Baum Professor of surgeryDepartment of Surgery, Institute of SurgicalStudies, University College London MedicalSchool, Charles Bell House, London W1P 7LD


2 Sigerist HE. In: Human experimentation, a guided step into theunknown (cited by W A Silverman). Oxford: OxfordUniversity Press, 1985:161.

3 Baum M. New approach for recruitment into randomisedcontrolled trials. Lancet 1993;341:812-4.

4 Baum M. Clinical trials—a brave new partnership: aresponse to Mrs Thornton. J Med Ethics 1994;20:23-5.

5 Harrison JE. Patients should not be discouraged fromentering trials. BMJ 1996;313:1488.

Patients may not understand enough togive their informed consent

Editor—Much debate has focused on theneed for informed consent and the ethicaldifficulties that arise when this is not

obtained.1 Little attention has been paid towhat patients understand that they haveconsented to.

We report preliminary data from a studyof 102 patients receiving radiotherapy forcancer. Twenty two per cent (22/99) had norecollection of consenting to the procedure(all had consented). Thirty six per cent (29/80) of those who did recall consentingthought that they had consented to “anyprocedure that the doctor thinks is neces-sary including chemotherapy, radiotherapy,or surgery.” Moreover, 60% (48/80) thoughtthat by consenting they had undertaken toaccept “any side effects caused by thetreatment,” and 44% (42/95) believed thatby consenting they would be unablesubsequently to complain about side effects.

Clearly, the issue of informed consentimplies a sharing of information, yet 24%(24/99) of our sample could not recall beingtold about any side effects from radio-therapy, not even common effects such asburning skin or tiredness, of which they wereinformed. These were all patients who hadhad an appointment with their consultantwhen treatment options and side effectswere discussed followed by a pretreatmentmeeting with a radiographer. In addition,60% (54/90) of patients received infor-mation leaflets and 47 out of 100 saw a spe-cialist cancer counsellor on at least oneoccasion. If patients are not retaining theinformation that they have been providedwith or if they are misunderstandingprecisely what they are consenting to theyare being ill equipped to make thepsychological adjustment that will be neces-sary throughout their treatment.

Our findings highlight the need formore research to be conducted into theprocess for obtaining informed consent andwhether patients take in and understandinformation given to them. If the subjecthas not taken in the information then theirconsent is hardly informed. It may be thatthe timing of information sharing is crucialas to whether it is retained and that thisshould be viewed as more of a process thana one off event.Charles Montgomery Senior registrar in psychiatryWonford House Hospital, Exeter EX2 5AF

Anna Lydon Senior registrar in clinical oncologyRoyal Devon and Exeter Hospital, Exeter EX2 5DW

Keith Lloyd Senior lecturerUniversity of Exeter, Postgraduate Medical SchoolDepartment of Mental Health, Wonford HouseHospital, Exeter EX2 5AF


Communication with potential subjectsneeds to be effective

Editor—As a past chairman of a localresearch ethics committee and a recentlypractising clinical oncologist and clinicalresearcher, I endorse the views of LenDoyal.1 I would argue that Jeffrey S Tobias’shighly reasonable anxieties for the wellbeingof individual research volunteers2 would bebetter served by much greater attentionbeing paid to the comparatively neglected

area of clinical interpersonal communica-tion. Nowhere in either article is this funda-mental issue clearly addressed.

My experience of dealing with researchprotocols from a wide range of sources,some of them extremely august, leads me tothe reluctant conclusion that the last featureto be tackled by a researcher is the means bywhich the nature of the research will bemade comprehensible to potential subjects.It is not uncommon for the local researchethics committee to have to rewrite thepatient information and consent literaturefor the applicant, and this is a commonsource of delay in obtaining approval.

Even when the written material isdeemed acceptable the diverse nature of thecircumstances and abilities of researchsubjects demands a personal presentation ofthe information by a senior member of theresearch team. This is, I suspect, the mostvulnerable point in the process, dependentas it is on the range of communication skillsavailable to the informer. The professionplaces a lower value on having effective abili-ties in interpersonal communication than itdoes on having more obviously acceptableconcrete medical and scientific skills.

I have seen in my own practice that withthe use of effective communication skillsmost patients can be given an individualised,accurate, and comprehensible paraphrase ofthe protocol information leaflet, within anacceptable time frame. It is, however,essential to have formally learnt the neces-sary skills to do so. Is this so different fromhaving had to master any other usefulclinical skill?

Those who aspire to undertake clinicalresearch should place as much emphasis ontheir ability to communicate effectively as onthe methodology and statistics considered tobe essential to the conduct of a trial. Surelythis is a more acceptable means of extendingthe range of trial opportunities than beingforced into the ethical dilemma resultingfrom denying the fundamental rights ofindividuals?Christopher Wiltshire Retired consultant clinicaloncologistIpswich, Suffolk IP8 4NN


2 Tobias JS. BMJ’s present policy (sometimes approvingresearch in which patients have not given fully informedconsent) is wholly correct. BMJ 1997;314;1111-4.(12 April.)

In routine practice the consent form is arequest form and informed consent isinformed choice

Editor—We read with interest RichardSmith’s editorial on the ethical problems ofinformed consent in research.1 However, forthe most part, doctors face the issues ofinformed consent in their daily routinepractice of patient care. It is in daily practicethat many doctors feel uncertain of theirrole and may fear litigation, despite thepublication of general guidelines. We thinkthat the principle of informed consentimplies that it is for the benefit of the doctor

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and not the patient to provide medical care,and this is especially reflected in the writtenoperative consent form. It is ultimately thepatients’ decision to opt or not to opt forcare and the doctor’s duty to providerelevant information. Therefore, we recom-mend informed consent for routine, non-research care should be renamed informedchoice. We also suggest that the consentform be renamed a request form. We believethat this terminology would be moreinformative to both doctors and patients.A C Frosh Ear, nose, and throat specialist registrarSt Mary’s Hospital, London W2 1NY

J Hanif Ear, nose, and throat registrarCharing Cross Hospital, London W6


*** At the time of going to press we hadreceived 18 other letters on informedconsent. We could not publish all of thesebecause of lack of space, but we do plan topublish another round of letters on this sub-ject. The 18 letters were equally dividedbetween those which thought that we shouldnever publish trials that do not include con-sent and those that thought we should.

Reintroduction of medicalofficers of health would solvemany problemsEditor—As the son of the secretary of theSociety of Medical Officers of Health whosuccessfully defended that splendid Victo-rian Liberal office against the Baldwingovernment (Dr V F Soothill), I write toexpress enthusiasm for Dr Lewis Moonieand Mr Sam Galbraith’s proposal that medi-cal officers of health should be reintro-duced.1 It is strange that Dr Moonie andMr Galbraith are Labour MPs, since thedeterioration in the attention paid tohygiene resulted from the introduction ofthe National “Illth” Service (ignorantBeveridge wrote that improved therapeuticservices would improve health and soreduce costs); the elimination of medicalofficers of health by the Heath governmentwas just the last step in a trend.

The attention of consultants in publichealth medicine to hygiene was lost to longterm care and disability. The recent outbreakof food poisoning due to Escherichia coli inScotland is a good example of the need formedical officers of health; such outbreakswould surely be eliminated if raw meat wassold only in shops that sold nothing else andif meat based cooked products wereproduced in production lines in whichdifferent equipment and staff were usedbefore and after cooking. That is the sort ofsensible independent suggestion that medi-cal officers of health would make.

Medicine’s greatest achievements are inprevention (hygiene, immunisation, nutri-tion, and birth control); if a patient sees adoctor then medicine has failed. Let usrestore the medical officer of health but withthe independence and protection that

resulted from the recognition in the wiser19th century that this is something tooimportant for politicians. Medical officers ofhealth should not be appointed by thesecretary of state, as these MPs suggested,but, as of old, should be hired and fired onlyat the instruction of a committee of theirpeers, and their reports should be publishedunaltered. A dirty butcher may have a cousinwho is a councillor.J F Soothill Emeritus professor, University of LondonPensylvania, Lodge Lane, Axminster EX13 5RT

1 Warden J. Move to bring back medical officer of health.BMJ 1997;314:249. (25 January.)

Many children remainunrestrained in carsEditor—While we agree with the pointsthat Ian Roberts and Carolyn DiGuiseppimake in their editorial on children in cars,1

we wish to draw attention to otherimportant aspects of children’s safety incars. Over the past few years three surveyshave been carried out on the use ofrestraints by car occupants in Fife, Scotland.In total, 13 933 car occupants in 7793vehicles have been surveyed at severalsurvey points throughout the county.2 3 Inaddition we have carried out detailedexaminations of the use of restraints by 596car occupants.4

The use of restraints by drivers and frontseat passengers was high, at 94% and 93%respectively. The use of restraints by childrenin the rear seats, however, was considerablylower and fell with increasing age of thechild; thus 70% of 0-1 year olds, 79% of 1-4year olds, 59% of 5-9 year olds, and 54% of10-14 year olds were restrained. The use ofrestraints was much lower in rear middleseats than rear side seats (40% v 61%). Thesedata relate to the use of restraints after theintroduction of the legislation in July 1991that required adult rear seat passengers towear a seat belt; we observed that the legisla-tion was associated with a 77% increase inthe use of rear seat belts by both adults andchildren.3

Three issues should be highlighted.Firstly, a substantial proportion of childrenremain unrestrained in cars, although theuse of seat belts by drivers and front seatpassengers is almost universal. The use ofrestraints was about 15% higher in vehiclesthat had rear seat belts fitted, as would beexpected, but this still means that a substan-tial proportion of children in rear seatstravel unrestrained in these cars. Secondly,we have consistently found that the use ofrestraints in taxis is low, with only 67% offront seat passengers and 21% of rear seatpassengers being restrained. Lastly, passen-gers were using restraint devices incorrectlyin 52% of vehicles surveyed. Rates of incor-rect use were highest with child seatrestraints, reaching 60% for two way seatsand 44% for rear facing seats. Thus 28% ofchildren were secured incorrectly.4 Asincorrect use reduces the effectiveness of

restraints and can itself result in injury5 webelieve that this is an important and under-recognised factor in injuries to childpassengers in Britain.Harry Campbell Senior lecturerDepartment of Public Health Sciences, Universityof Edinburgh, Edinburgh EH8 9AG

Sheena MacDonald Data analystCentre for Health and Social Research, GlenrothesKY7 5PB

1 Roberts I, DiGuiseppi C. Children in cars. BMJ 1997;314:392. (8 February.)

2 Baijal E, Carter H, Davie A. Car occupant restraint use inFife: an observational study. Public Health 1993;107:31-5.

3 Campbell H, Gorman D, Richardson P. An observationalstudy of car occupant restraint in Fife: impact of recentlegislation. Public Health 1993;107:429-35.

4 Campbell H, MacDonald S, Richardson P. High levels ofincorrect use of car seat belts and child restraints inFife—an important and under-recognised road safetyissue. Injury Prev (in press).

5 Johnston C, Rivara FP, Soderberg R. Children in carcrashes: analysis of data for injury and use of restraints.Pediatrics 1994;93:960-5.

Solar ultraviolet radiation isnot a major cause of primarycutaneous non-Hodgkin’slymphoma See p 1451

Editor—Ultraviolet radiation is known tocause cutaneous malignancies such assquamous and basal cell carcinoma andmelanoma. It has been hypothesised thatultraviolet radiation may also increase therisk of non-Hodgkin’s lymphoma.1 Asevidence exists that specific local factors areimportant in the aetiology of non-Hodgkin’slymphomas at certain extranodal sites—forexample, Helicobacter pylori infection isassociated with primary gastric lymphomabut not with lymphomas at other sites2—Iinvestigated the relation between the inci-dence of primary cutaneous non-Hodgkin’slymphoma and ambient levels of solarultraviolet radiation using routinely col-lected, population based data on cancerincidence and published measures of ambi-ent solar ultraviolet radiation.3 4

Age adjusted and sex adjusted inci-dence rates of cutaneous non-Hodgkin’slymphoma in white people were derived(with 95% confidence intervals) for 10 areasin the United States (fig 1). Few countrieshave such information available, and the

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Seattle (n=145)

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New Mexico(n=51)

Hawaii(n=8)

San Francisco (n=186)

Atlanta(n=46)

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Connecticut(n=156)

Fig 1 Incidence (adjusted for age and sex) ofprimary cutaneous non-Hodgkin’s lymphoma inwhite people in 10 areas of the United States, inrelation to ambient solar ultraviolet radiation

Letters


analyses were restricted to the United Statesbecause of the scale, consistency, and qualityof data collection; the broad range ofultraviolet exposure between locations; andthe need to avoid inclusion of diverse racialgroups. At each location, the average dailydose of ultraviolet radiation (UVB) was cal-culated from annual measurements ofambient ultraviolet light between the hoursof 0830 and 1830 for each 10° of latitude,after adjustment for seasonal cloud cover.4

Overall, the incidence of primary cutane-ous non-Hodgkin’s lymphoma does notincrease with increasing levels of ambientsolar ultraviolet radiation (fig 1; regressioncoefficient − 0.02, P = 0.16), nor is there apositive association for all non-Hodgkin’slymphomas in relation to solar ultravioletexposure in the United States.5 Similarly, theproportion of all non-Hodgkin’s lymphomasmanifest as primary cutaneous tumours doesnot increase with increasing levels ofultraviolet radiation ( − 0.97, P = 0.39). For allareas combined there is no clear excess inwhite people (incidence 0.35 per 100 000(95% confidence interval 0.33 to 0.37) a year,based on 1067 cases) compared with blackpeople (0.41 per 100 000 (0.34 to 0.48) a year,based on 147 cases), which might be expectedif ultraviolet radiation increased the risk ofcutaneous non-Hodgkin’s lymphoma. Hence,these results suggest that exposure toultraviolet radiation is not—as it is withmelanocytic and other non-melanocytic skincancers—a major risk factor for primary non-Hodgkin’s lymphoma of the skin.Robert Newton Medical Research Council trainingfellowImperial Cancer Research Fund, CancerEpidemiology Unit, Radcliffe Infirmary, OxfordOX2 6HE

I thank Jacques Ferlay for his help.

1 Adami J, Frisch M, Yuen J, Glimelius B, Melbye M.Evidence of an association between non-Hodgkin’slymphoma and skin cancer. BMJ 1995;310:1491-5.

2 Parsonnet J, Hansen S, Rodriguez L, Gelb AB, Warnke RA,Jellum E, et al. Helicobacter pylori infection and gastriclymphoma. N Engl J Med 1994;330:1267-71.

3 Surveillance, epidemiology and end results (SEER) program spe-cial public use CD-ROM (1973-91), National Cancer InstituteSurveillance Program. Bethesda, MD: National Institutes ofHealth, July 1994.

4 Diffey BL, Elwood JM. Tables of ambient solar ultravioletradiation for use in epidemiological studies of malignantmelanoma and other diseases. In: Gallagher R, Elwood JM,eds. Melanoma epidemiology. Klewer: New York, 1993:8l-105.

5 Hartge P, Devessa SS, Graumen D, Fears TR, Fraumeni JF.Non-Hodgkin’s lymphoma and sunlight. Journal of theNational Cancer Institutes 1996;88:298-300.

What is it acceptable to die of?Editor—The issue of 15 February wasindeed thought provoking. Having had arecent series of four articles in the journal,the Rationing Agenda Group aired yet moreof its ideas,1 2 while authors of letters showedjust how impossible it will be to reach anyconsensus. In one of these letters J Dunstanasked that a minimum requirement for acivilised health system should be that peopleshould not have to die in avoidable distress.3

Do we, on that single criterion, fail the civili-sation test?

David P Taggart and Stephen Westabyreviewed the surgical management of heartfailure,4 telling us that the annual mortalityis 25-50% and describing this as “dismal.”Leaving aside those patients with trulyremediable causes of heart disease, such asunsuspected valve disease, surely a goodproportion of these patients are dying, as weall must, and our duty is that they do not diein distress. People with terminal cancer canbe accepted as dying (although paradoxi-cally many people with incurable cancer arenot so obviously ill as those with incurableheart disease); it seems that people with ter-minal heart disease cannot.

Minerva, in the same issue, pointed outthat declining mortality from coronaryheart disease is a factor in the increasingnumber of hospital admissions for heartfailure. So we rescue people from a relativelysudden death from myocardial infarctiononly to inflict on them a more prolongeddeath from progressive heart failure. Tag-gart and Westaby describe heart failure as amajor health problem, but surely it willalways be so. Surgery, even if successful, willonly postpone the inevitable; and heart fail-ure is likely to be a major cause of deathwhen these patients eventually die—whichthey will.

With a request that they do not deflectthe argument or risk accusations of ageismby concentrating on younger patients withheart failure, I should like to ask Taggart andWestaby the question that J P Richardsposed in a personal view5: what do you con-sider it is acceptable to die of?Neville W Goodman Consultant anaesthetistDepartment of Anaesthetics, Southmead Hospital,Bristol BS10 5NB

1 New B. Defining a package of healthcare services the NHSis responsible for. The case for. BMJ 1997;314:503-5.(15 February.)

2 Klein R. Defining a package of healthcare services theNHS is responsible for. The case against. BMJ 1997;314:506-9. (15 February.)

3 Dunstan J. Rationing health care. BMJ 1997;314:515.(15 February.)

4 Taggart DP, Westaby S. Surgical management of heart fail-ure. BMJ 1997;314:453-4. (15 February.)

5 Richards JP. Evidence based general practice. BMJ1997;314:525. (15 February.)

Redback spider is nowestablished in Japan: bites canbe recognised by a unique signEditor—The infamous Australian redbackspider (Latrodectus mactans hasselti; fig 1),known for inhabiting the underside of toiletseats and biting bottoms, is now in Japan.More alarming to the Japanese is that thesespiders—relations of the black widow—arecontinuing to breed and spread in the Japa-nese winter, surviving temperatures as lowas 4˚C by living near heating systems. Thespiders often live near or beneath housesand females will bite defending their nests,which can contain 300 eggs. Japan, like Eng-land, does not have poisonous spiders andpublic panic is escalating. Despite promptaction by the authorities, fumigation pro-grammes have not eradicated the pest.

These Japanese redbacks could conceivablysurvive in Britain and therefore constitute areal threat if accidentally imported.

The spider is ubiquitous in Australia1

and may have been introduced in the 1870s.Bites have caused death1 2 in children.Anaphylaxis and death in adults haveoccasionally been reported. The venom is aneurotoxin called latrotoxin, which depletesacetylcholine from nerve terminal vesiclesand causes presynaptic blockade. A safeantivenom3 has been available since 19561

but delay in giving it may occur2 if the spideris squashed beyond recognition. Around78% of bites are on hands, feet, and theextremities3 and initially the bite causes littlediscomfort. Later intense pain begins anduniquely the bitten area sweats profusely.Only 2.3% of bites are now on the bottomand genitalia3 compared with 9.7% in 1978.4

The shortest time recorded between the biteand death is 54 hours. Deaths from bites ofLatrodectus species have been recorded inItaly and Yugoslavia.5

The larger and more dangerous femalespiders (males are smaller and have fangswhich cannot penetrate human skin) areblack and have an abdomen the size of a peawith an orange-red, pink, or grey stripe.1 Aus-tralians have learnt to ignore the company ofthe redback but it is a pest that Japan and therest of the world can do without. Havingfound a large female redback and eggs undermy patio table this weekend in Sydney, thereaction provoked is like discovering that theproperty has lice. I have identified only onepleasure associated with possession of theredback spider. Friends tell me that aschildren they would disturb a nest and dropbricks on the insects; apparently the abdo-men makes a loud pop when squashed.Peter Horton NH and MRC research fellowNational Pancreas Transplant Unit, University ofSydney, Westmead Hospital, Westmead, NSW 2145,Australia

1 Sutherland SK. The red-back spider (Latrodectus mactanshasselti). In: Sutherland SK, ed. Venomous creatures ofAustralia. 3rd ed. Melbourne: Oxford University Press,1985:66-7.

2 Jelinek GA, Banham NDG, Dunjey SJ. Red-back spider-bites at Fremantle Hospital, 1982-1987. Med J Aust1989;150:693-5.

3 Sutherland SK. Antivenom use in Australia. Premedica-tion, adverse reactions and the use of venom detection kits.Med J Aust 1992;157:734-9.

4 Sutherland SK, Trinca JC. Survey of 2144 cases of red-backspider bites: Australia and New Zealand, 1963-1976. Med JAust 1978;ii:620-3.

5 Maretic Z. Iatrodectism: variations in clinical manifesta-tions provoked by Latrodectus species of spiders. Toxicon1983;21:457-66.

A.N.T./N

HPA

Fig 1 Australian redback spider

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1484 BMJ VOLUME 314 17 MAY 1997

Segregated health statisticsperpetuate racial stereotypesEditor—Unlike Alexander R P Walker, wewelcome the desegregation of health statis-tics in South Africa1 and believe that theroutine use of ethnic or racial categories inhealth research is often ill conceived,misleading, and divisive.2 It is ill conceivedbecause using nationality and physical char-acteristics (such as African, European, black,and white) to differentiate between variousgroups tends to reinforce the discreditedview that geographically isolated and geneti-cally distinct human races exist. It is mislead-ing because using these categories to assessdisparities in health focuses attention oninherent biological and behavioural causesand ignores the impact of social forces thatdetermine access to health and health care.It is divisive because using these categorieslegitimises the process of discrimination andreinforces a racially structured view ofsociety.

Nowhere are these issues more relevantthan in post-apartheid South Africa, wherethe “population group” categories createdand enforced by the 1950 Population Regis-tration Act have been used to documentpatterns of disease. Indeed, Walker et al’sinterethnic comparison of temporalchanges in mortality from ischaemic heartdisease used population group categories toidentify those groups most at risk.3 Althoughthe authors acknowledged that ischaemicheart disease is linked to a variety of behav-ioural and socioeconomic factors, theabsence of these variables in the South Afri-can database distorted their interpretationof differences in disease between differentgroups. By comparing the incidence ofischaemic heart disease among black, Asian,and white South Africans with that found instudies of African, Indian, and Britishsubjects they reinforced the view thatheritable characteristics were somehowresponsible for the interethnic differencesthey observed. They also stigmatised theleast healthy groups by suggesting that therelative decline in mortality from ischaemicheart disease among white South Africansindicated that “whites have...taken some pre-ventive action, although Asians and col-oureds apparently little.” Nowhere did theyacknowledge the impact of discriminationon the socioeconomic and health status ofdifferent “population groups.”

Using ethnic and racial categories torectify inequalities in health is perhaps themost justifiable use of these categories inhealth research.4 But using these categoriesto “identify and quantify the target popula-tions who are most in need of help,” asWalker suggests, raises two fundamentalproblems: firstly, it would necessitate thecontinued use of the externally imposed cat-egories traditionally used to enforce disad-vantage, and, secondly, it would perpetuateinequality by ignoring disadvantaged sub-jects from other groups. Targeting all socio-economically disadvantaged subjects wouldhelp rectify the impact of past and current

social injustice, including ethnic discrimina-tion and racism, without relying on ethnic orracial categories to identify disadvantage.5

George T H Ellison Research managerInstitute of Urban Primary Health Care, AlexandraHealth Centre and University Clinic, Johannesburg,South Africa

Thea de Wet Project managerBirth to Ten, Urbanisation and Health Programme,Medical Research Council, Johannesburg,South Africa

Carel B IJsselmuiden HeadDepartment of Community Health, University ofPretoria, Pretoria, South Africa

Linda M Richter HeadDepartment of Psychology, University of Natal,Pietermaritzburg, South Africa

1 Walker ARP. Data are not now collected by ethnic group inSouth Africa. BMJ 1997;314:220. (18 January.)

2 Ellison GTH, De Wet T, IJsselmuiden CB, Richter LM.Desegregating health research and health statistics inSouth Africa. S Afr Med J 1996;86:1257-62.

3 Walker ARTP, Adam A, Kustner HGV. Changes in totaldeath rate and in ischaemic heart disease death rate ininterethnic South African populations, 1978-1989. S AfrMed J 1993;83:602-5.

4 Ellison GTH, De Wet T, IJsselmuiden CB, Richter LM.Desegregating health statistics and health research inSouth Africa. S Afr Med J 1997;87:330-1.

5 Krieger N, Williams DR, Moss NE. Measuring social classin US public health research: concepts, methodologies andguidelines. Ann Rev Public Health (in press).

Incidence of myocardialinfarction is affected bydeprivation inBuckinghamshire tooEditor—Caroline Morrison and colleaguesreport that within a relatively deprived partof north Glasgow the incidence of myocar-dial infarction in the poorest areas wasroughly double that in the more affluentneighbourhoods.1 It may be a surprise thatsimilar results have been obtained in a moreprosperous part of Britain (table 1).

The numerator data in table 1 weretaken from Buckinghamshire HealthAuthority’s contract monitoring databasefor 1994-5. The denominator data weretaken from the census, updated with datafrom a postal survey conducted by Bucking-hamshire County Council in 1994. All elec-toral wards in the county were grouped intofifths of roughly equal population accordingto the ward Townsend score (a census baseddeprivation score2). Hospital admission ratesstandardised for age and sex were calculatedfor acute myocardial infarction and variousother categories of admission for theseaggregated populations.

The incidence figures for the two studiesare not directly comparable—for example,those for Glasgow include deaths occurringoutside hospital. Despite these differences,

the two datasets show a strikingly similartwofold variation in incidence according todeprivation. Inequalities by social class areclearly not restricted to inner city communi-ties.3 It is also encouraging that routine NHSdata seem to be sufficiently robust todocument local inequalities.John N Newton Consultant epidemiologistUnit of Health-Care Epidemiology, University ofOxford, OX3 7LF

Shirley Holton Consultant in public health medicineBuckinghamshire Health Authority, AylesburyHP19 3ET

1 Morrison C, Woodward M, Leslie W, Tunstall-Pedoe H.Effect of socioeconomic group on incidence of, manage-ment of, and survival after myocardial infarction andcoronary death: analysis of community coronary eventregister. BMJ 1997;314:541-6. (22 February.)

2 Townsend P, Phillimore P, Beattie A. Health and deprivation.Inequality and the north. London: Croom Helm, 1988.

3 Holton S. Socioeconomic differences in mortality. BMJ1995;310:807.

Project will assess effects ofpatients writing about theirterminal illness onself perceived quality of lifeEditor—Naomi Craft writes of autobiogra-phies about dying.1-3 She reasons that theseaccounts can help readers feel better abouttheir own deaths and satisfy some fearfulcuriosity about dying; publishing suchaccounts can fulfil a need of the writers tocreate a powerful memorial.

The process of writing expressively andexploratively about dying can also haveintensely therapeutic benefits, we believe.“Writing therapy in palliative care” is a pilotproject started by the palliative medicinesection of Sheffield University last Septem-ber. Writing therapy is being offered toinpatients and day patients at Ashgate Hos-pice, Chesterfield, with effects on the controlof symptoms and on spiritual distress beingreported by medical and nursing staff. Itbuilds on the experience of the “writingtherapy in primary care” project at thedepartment of general practice, SheffieldUniversity (unpublished findings).

One inpatient arrived at the hospicevery distressed, expressing herself as unableto come to terms with having cancer andrequesting psychological help. Her mono-logue, which was taken down verbatim, wasinterrupted only by thoughtful silence; shereread and checked the writing. Here aretwo extracts: “You wake up in the morningand, no, the cancer’s not gone, I know it’snot.... It [the writing] must be coming fromthe inside, the tears are rolling down.” Later,she emotionally dictated about wishing to

Table 1 Relative risk of admission for acute myocardial infarction in population of Buckinghamshire

Fifth of population bydeprivation score

Totalpopulation

Admissions for acutemyocardial infarction*

Relative risk adjustedfor age and sex†

1 (least deprived) 120 540 35 1

2 121 450 53 1.63

3 118 818 45 1.47

4 118 887 62 2.07

5 (most deprived) 120 636 69 2.54

*Aged 35-64 only. †÷2 for trend=22.5, P<0.0001.

Letters


commit suicide: “I never thought I’d tell any-one that, no I didn’t. And cried again. Threetimes I’ve seen you and always cried. Neverwith anyone else. My son wanted to knowwhat we did and I said, ‘How can I tell you? Idon’t know! But this lady, she seems to getright inside you. Right into the centre ofyour being.’ ”

Although there have been many writingresidencies in hospices,4 5 the approach hasnot yet been researched. Our pilot study isbeginning to define measurable outcomes.In a proposed full scale project we intend totest the effect of the process of writing onself perceived quality of life, linking it to thelevel of cognitive functioning (and drugrelated impairment by, for example, opioids)and opioid dose. Finished writings can offerinsight to nursing and medical staff and sup-port to other sufferers, as well as therapeuticbenefit to the writer and the help to readers,as Craft suggests.Gillie Bolton Research associateSam Ahmedzai ProfessorDepartment of Surgical and Anaesthetic Sciences,Palliative Medicine Section, University of Sheffield,Royal Hallamshire Hospital, Sheffield S10 2JF

1 Craft N. A very public death. BMJ 314:383-4. (1 February.)2 Moore O. Looking AIDS in the face. London: Picador, 1997.3 Harris M. Odd man out. London: Daily Telegraph, 1997.4 Philipp R, Robertson I. Poetry helps healing. Lancet

1996;347:332-3.5 Alexander L. Writing in hospices. In: Kaye C, Thee T, eds.

The arts in health care. Jessica Kingsley, 1996.

South Asian diabetic patientsneed more education abouttheir illnessEditor—I hope that Veena Soni Raleigh’sarticle on the necessity to plan now for thefuture health needs of Britain’s South Asiansis read and understood by the people whomatter (Britain’s health planners and theholders of the health budgets).1 We arecertainly facing a serious problem for theSouth Asian community in the next few dec-ades. The article quotes a study fromNottingham in 1990 on the knowledge ofdiabetes and its complications among SouthAsians attending a hospital diabetic clinic,which compared them with matched whitediabetic patients.2 A more recent study, of200 randomly selected South Asian patientsattending Manchester Diabetes Centre in1993-4, found similar results: 168 patientscould not name any diabetic complications,99 were unsure of the reasons for monitor-ing and controlling glucose concentrations,175 did not know the purpose of attend-ances at the clinic to screen for early compli-cations, and 183 did not know what achiropodist did or how to see one. Inaddition, a hard core, consisting of olderwomen with no experience of formal educa-tion, was found to have poorer diabetic con-trol than the rest as well as less knowledge ofdiabetes (the average glycated haemoglobinconcentration for the 107 women in thestudy was 8.79%, compared with 8.14% forthe 94 men (P = 0.04)). These patients’educational requirements need to beurgently addressed if we are to prevent

further morbidity, improve quality of life,and use resources effectively.

The patients reported on in the Notting-ham and Manchester studies were largelyPakistani Moslems. British South Asiancommunities vary enormously in terms oflanguage, culture, religion, diet, and degreeof Westernisation. In addition, this variationis dynamic: it changes from year to year asthe younger generations grow up in aBritish environment. Any educational inter-ventions or health service programmes forSouth Asians need cultural assessment inthe environment of the target communityand also careful audit by the communityitself to avoid irrelevance and to promoteoptimal uptake.Kamila Hawthorne General practitionerFour Elms Medical Centres, Cardiff DF2 1AF

1 Raleigh VS. Diabetes and hypertension in Britain’s ethnicminorities: implications for the future of renal services.BMJ 1997;314:209-13. (18 January.)

2 Hawthorne K. Asian diabetics attending a British hospitalclinic: a pilot study to evaluate their care. Br J Gen Pract1990;40:243-7.

Shorter preoperative fluid fastsreduce postoperative emesisEditor—We support the recommendationson preoperative fasting offered by S MGreenfield and colleagues.1 Not only arefasting times far longer even than istraditionally thought necessary but reducingthe fluid fast, as they advocate, seems to ben-efit patients after anaesthesia too.

We audited fasting times and post-operative emesis in inpatients having elec-tive gynaecological surgery after somemembers of our department became con-cerned that shortening the preoperativefluid fast would make postoperative emesismore likely. Data were collected on 93patients fasted conventionally; 89 more wereallowed to drink water until two hoursbefore the induction of anaesthesia. The twogroups were comparable with respect to riskfactors for postoperative emesis.

We had three main findings.(1) The mean duration of fasting was

10.0 hours in the patients fasted convention-ally (range 5.5-18); this was reduced to 3.4hours (1.7-6.0) in our second group.

(2) No adverse effects were seen in thepatients given water to drink.

(3) Nausea and vomiting were common,as might be expected in gynaecologicalpatients; 24 (26%) of the patients fasted con-ventionally had postoperative nausea and 33(35%) vomited. However, drinking water upto two hours before surgery seemed to makepostoperative emesis less likely: only 19(21%) in the second group experiencednausea and 16 (18%) vomited.

One reason why patients may havenausea postoperatively was alluded to byPalazzo and Strunin, who observed that asubstantial number of patients felt sick afterfasting for up to 8.5 hours2; if patients go tosleep nauseated the nausea is likely to persistinto the postoperative period. Alternatively,vomiting after surgery is often caused by

drinking too soon during recovery; patientswho have drunk water within a few hours ofinduction of anaesthesia should be less thirstypostoperatively and not try to drink so soon.

We urge colleagues to ensure thatpatients are not deprived of fluid for longerthan six hours even when a minimum sixhour fast is imposed. As a result of our auditwe have changed our departmental guide-lines to allow most patients to drink wateruntil two hours before sedation or anaes-thesia.

Our study was sequential and the anaes-thetic techniques, though well matched,were not standardised; we would be inter-ested to see whether the results of arandomised trial confirm our suspicions thata shortened fluid fast not only makespatients more comfortable but also reducespostoperative emesis.A F Smith Senior registrar in anaesthesiaH Vallance Senior registrar in anaesthesiaR M Slater Consultant anaesthetistDepartment of Anaesthesia, Manchester RoyalInfirmary, Manchester M13 9WL

1 Greenfield SM, Webster GJM, Vicary FR. Drinking beforesedation. BMJ 1996;314:162. (18 January.)

2 Palazzo MGA, Strunin L. Anaesthesia and emesis. I.Aetiology. Canadian Anaesthetists’ Society Journal 1984;31:178-87.

Pharmacists are key membersof primary health care teamsEditor—I was disappointed by the article byColin P Bradley and colleagues.1 In theirsummary the authors suggest that the initia-tives that may have the biggest impact arethose encouraging closer collaborationbetween general practitioners and commu-nity pharmacists. Unfortunately, the articleconcentrates almost exclusively on the wayin which this collaboration controls the costof prescribing. The much greater benefitsthat could arise for the two professions aredismissed in a few words.2 3

My practice has had a full timenon-dispensing pharmacist for nearly threeyears. Formulary and prescribing policiesnow form little of her work; we have movedbeyond mere cost control to tackle the realissues of rational prescribing—safe, effective,available, and acceptable to the patient. Allof us in the team, including patients, find herrole invaluable. To dismiss this model asbeing “unlikely to be acceptable to the phar-macy profession as a whole” grosslyunderestimates the full potential of thispartnership. The authors seemingly wish tokeep the pharmacist at arm’s length, not as akey member of the primary health careteam, notwithstanding staffing problems.The authors mention that this modelalready exists in secondary care; it is nowlogical to extend it into primary care.W Denys E Wells General practitionerNorthgate Medical Centre, Aldridge, WalsallWS9 8QD

1 Bradley CP, Taylor RJ, Blenkinsopp A. Developing prescrib-ing in primary care. BMJ 1997;314:744-7. (8 March.)

2 Bradley M. The role of the practice pharmacist—the newmember of the team. VFM Update 1996;2:27-8.

3 McGregor S. Pharmaceutical care in the general practicesurgery. VFM Update 1996;2:4-5.

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1486 BMJ VOLUME 314 17 MAY 1997

Informed consent in medical research. Failure to publish completed randomised controlled trials is...

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