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CONSORT statement on the reporting standards of clinical trials

Recommendations are inappropriate fortrial reports

EditorIn his editorial on the CONSORTstatement Douglas G Altman states thatsince only randomised trials have thepotential directly to affect patient care ... it is... reasonable to require higher standards forpapers reporting randomised trials thanthose describing other types of study.1 Butalthough randomised trials are usually the

preferred approach for the unbiased evalua-tion of treatments, non-randomised obser-

vational studies also influence treatment.Because the correct interpretation of obser-

vational studies is much more difficult,largely due to uncontrollable biases, theirdescription and analysis call for at least asmuch care as do randomised trials. Some-times, of course, randomised comparisonsare unnecessaryfor example, to determinethe value of fetoprotein screening forneural tube defects.

CONSORT is the product of delibera-tions conducted almost entirely throughNorth American journals.2 Journal editorsand statisticians are well represented amongthose involved, but clinicians and others withexperience in actually conducting trials lessso. Experience of the procedures recom-mended seems to be limited and not whollypositive. The authors of one trial report whohad been persuaded to rewrite it3 in thestructured format expressed mixed feelings:the paper was rendered less readable withideas that are logically linked together(such as point estimates with 95% confi-dence intervals) torn asunder.4 Inflexibilityand a lengthier manuscript were otherreported disadvantages. The editor stated

that a journal should change the way itstructures articles only when there is goodagreement on the new format in thecommunities we serve4; this includes writersand readers of trial reports as well as editors.Feedback from the test case3 or from othercommentators does not seem to have mate-rially altered the final version of CONSORT.By announcing its decision, less than a fort-night after publication of CONSORT, theBMJ pre-empted input from many withexperience of planning, conducting, andreporting trials.

Few will dispute the need for improve-ments in the reporting of all studies with

implications for patient care, whatever theirdesign. But without appropriate consulta-tion, the BMJ seems to have made its

decision on CONSORT prematurely. Therequirement that randomised trials reportthe numbers of patients excluded is gener-ally pointless,5 and making authors indicate

where a large number of checklist items aredealt with would be unduly prescriptive.TheCONSORT recommendations should not

be imposed unilaterally. Others withexperience of trial conduct should beconsulted on the nature of any guidelines

for the reporting of randomised trials and,more importantly, of observational studiesof treatments.T W Meade Professor

Nicholas Wald ProfessorWolfson Institute of Preventive Medicine, StBartholomews and the Royal LondonSchool ofMedicine and Dentistry, London EC1M 6BQRory Collins ProfessorClinical Trial Service Unit and EpidemiologicalStudies Unit, Radcliffe Infirmary, Oxford OX2 6HE

1 Altman DG. Better reporting of randomised controlledtrials: the CONSORT statement. B MJ1996;313:570-1.(7 September.)

2 Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I,et al. Improving the quality of reporting of randomizedcontrolled trials: the CONSORT statement. JAMA

1996;276:637-9.3 Williams JW, Holleman DR, Samsa GP, Simel DL. Rand-

omized controlled trial of 3vs10 days of trimethoprim/sulfamethoxazole for acute maxillary sinusitis. JAMA1995;273:1015-21.

4 Rennie D. Reporting randomized controlled trials: anexperiment and a call for responses from readers. JAMA1995;273:1054-5.

5 Peto R. Clinical trial reporting.Lancet1996;348:894-5.

Reporting of refusal of consent to takepart in clinical trials is still poor

EditorThe CONSORT statement, sum-marised by Douglas G Altman,1 requiresinvestigators to give details of eligiblepatients not recruited to a clinical trial,

which means stating explicitly how many

patients refused to give their informed con-sent.We surveyed 11 specialist clinical jour-

nals from 1995 published or distributed byBMJ Publishing available in our localmedical library; seven were British and fourNorth American. We looked at all fullreports of randomised clinical trials forexplicit statements or implicit suggestions(such as all consecutive patients werestudied) about refusal of consent. We sentquestionnaires to all first authors of reportscontaining implicit suggestions and to arandom sample of first authors of reportsthat gave no mention of refusals.

There were 195 suitable reports. Con-sent rate was given in nine reports, withrates of refusal between 0% and 84%

(median 7%; mean 25%). A further ninereports contained implicit suggestions ofno refusals; all the first authors of thesereports returned their questionnaires, andin two of the studies there had been refusals(10% and 8%).

Eighteen first authors replied from ourrandom sample of 20 taken from theremaining 177 reports that gave no infor-mation on refusal of consent. Four authorshad kept records of refusals, one did notknow, and the rest estimated or stated frommemory the rates of refusal, which were upto 20%. One respondent, commenting on

the low refusal rate, added that the doctorpersonally following them helped patientsto agree to anythingrightly or wrongly.

Wager et al commented that refusal mayindicate that you are conscientious enoughto ensure that [subjects] are properlyinformed and make a free decision.2

There have been earlier surveys aboutconsent biasfor example, one in whichrefusal rate was stated in about 40% ofreports3 and comments (for example, byCharlson and Horwitz4), but reporting ofconsent rates in our surveyed journals wasunusual, and the information was often notavailable. Even when an implicit statement is

given, readers cannot assume that all

Advice to authors

We receive more letters than we can publish: wecan currently accept only about one third. Weprefer short letters that relate to articlespublished within the past four weeks. We alsopublish some out of the blue letters, whichusually relate to matters of public policy.

When deciding which letters to publish wefavour originality, assertions supported by dataor by citation, and a clear prose style. Lettersshould have fewer than 400 words (please give a

word count) and no more than five references(including one to the BMJ article to which theyrelate); references should be in the Vancouverstyle. We welcome pictures.

Letters should be typed and signed by eachauthor, and each authors current appointmentand address should be stated. We encourage youto declare any conflict of interest. Please enclose astamped addressed envelope if you would like toknow whether your letter has been accepted orrejected.

We may post some letters submitted to us onthe world wide web before we decide onpublication in the paper version. We will assumethat correspondents consent to this unless they

specifically say no.Letters will be edited and may be shortened.

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subjects have given consent. A largeimprovement is needed to conform toCONSORT.

A different worry concerned the two firstauthors who did not reply to a repeatedrequest for information, despite beingoffered the chance simply to put theunanswered questionnaire back in theprepaid return envelope. The authors mayhave moved on, but for papers published in

1995 this is unsatisfactory, especially if dataare supposed to be more freely available.5

We hope that their silence does not indicatesome abuse of consent.Helen J Bromhead Senior house officer

Neville W Goodman Consultant anaesthetistDepartment of Anaesthetics, Southmead Hospital,Bristol BS10 5NB

1 Altman DG. Better reporting of randomised controlledtrials: the CONSORT statement.BMJ1996;313:570-1.

2 Wager E, Tooley PJH,Emanuel MB, Wood SF. How to getpatients consent to enter clinical trials. BMJ1995;311:734-7.

3 Douglas S, Briones J, Chronister C. The incidence ofreporting consent rates in nursing research articles.Image

J Nurs Sch1994;26:35-40.4 Charlson ME, Horwitz RI. Applying results of ran-

domised trials to clinical practice: impact of losses beforerandomisation.BMJ1984;289:1281-4.

5 Delamothe T. Whose data are they anyway? BMJ1996;312:1241-2.

MRC uses checklist similar toCONSORTs

EditorDouglas G Altmans editorial high-lights the educational potential of theCONSORT checklist in increasing aware-ness of what constitutes a good trial.1 As ofthis year the Medical Research Councilrequires all investigators who seek funds forclinical trials to present their applications ina structured format. Potential applicants are

sent a list of headings similar to theCONSORT checklist and asked to make anentry under each heading. The reasons thecouncil has adopted this approach aretwofoldfirstly, to make the peer reviewprocess more cost effective both for appli-cants and reviewers, and, secondly, tointroduce an increased awareness of therequirements of a good trial at an early stageof trial development. The drafting of thischecklist was informed by two 1994 publica-tions on the reporting of clinical trials,2 3 andafter a pilot period we shall review its struc-ture. At this stage we will take into accountthe details of the CONSORT statement with

a view to encouraging a continuity from trialinception to publication.Liam B OToole Trials managerMedical Research Council, London W1N 4AL

1 Altman, DG. Better reporting, of randomised controlledtrials: the CONSORT statement.BMJ1996;313:570-1.

2 Standards of Reporting Trials Group. A proposal forstructured reporting of randomised controlled trials.

JAMA1994;272:1926-31.3 Working Group on Recommendations for Reporting of

Clinical Trials in the Biomedical Literature. Call for com-ments on a proposal to improve reporting of clinical tri-als in the biomedical literature; a position paper. Ann

Intern Med1994;121:894-5.

Authors reply

Editor

We agree with T W Meade and col-leagues that important information may begained from observational studies. It is

because the interpretation of such studies isharder and because less evidence wasavailable in this area of reporting that wedecided to see how the statement on report-ing of randomised trials fared. Now thatCONSORT has been published and is beingevaluated, our attention has moved to thereporting of systematic reviews and observa-tional studies.

Meade and colleagues are confused

about the various initiatives. As they may seefrom the editorial by one of us which theycite,1 two independent groupsthe SORTand the Asilomar groupmet almost simul-taneously to set up standards for the report-ing of randomised trials. SORT in particularinvolved several active clinical trialists whohave randomised many tens of thousands ofpatients between them. Both groups pub-lished their statements.2 3As an experiment,one clinical trial was rewritten in the SORTformat; as was noted in the editorial,1 theauthors found this tedious. So did readers.

After receiving numerous comments, repre-sentatives of both groups got together and

worked out a simpler solution,more friendlyto researchers, reviewers, and readers. This

was published as the CONSORT statement,4

accompanied by an explanatory editorial.5

In contrast, therefore, to what Meade andcolleagues write, feedback has stronglyinfluenced the final statement.

The BMJ is by no means alone orprecipitate in adopting CONSORT. About80 journals from around the world haveadopted CONSORT or are seriously think-ing of doing so. The vast majority of lettersthat we have received have been positive.

Though we do not understand why goodscientific standards should not be universal,

we are happy to note that Freemantle andhis colleagues in England liked theinitiative.6 We are not suggesting to peoplehow they should conduct clinical trials,merely how to improve the quality of thereporting. We are delighted that Meade andcolleagues have not raised a single substan-tive scientific criticism, which suggests thatthe journals adopting the CONSORT state-ment have made a wise choice. Still,CONSORT is not set in concrete and islikely to change in the light of experience.

We believe that CONSORT represents areasonable request from editors, reviewers,and readers that authors should include the

various bits of information without whichthe report would be meaningless. Given thatthe information is provided, we think it isreasonable that they are asked to say whereit can be found.Douglas G Altman HeadICRF Medical Statistics Group, Centre for Statisticsin Medicine, Institute of Health Sciences, OxfordOX3 7LFDavid Moher ScientistClinical Epidemiological Unit, Ottawa CivicHospital, Ottawa, Ontario K1Y 4E9, CanadaDrummond Rennie Deputy editor, JAMA (West)Institute for Health Policy Studies, 1388 SutterStreet, San Francisco, CA 94109, USA

1 Rennie D. Reporting randomized controlled trials. Anexperiment and a call for responses from readers. JAMA1995;273:1054-5.

2 Standards of Reporting Trials Group. A proposal forstructured reporting of randomized controlled trials.

JAMA1994;272:1926-31.3 The Asilomar Working Group on Recommendations for

Reporting Clinical Trials in the Biomedical Literature.Checklist for inclusion in reports of clinical trials. Ann

Intern Med1996;124:741-3.4 Begg C, Cho M, Eastwood S, Horton R, Moher D,Olkin I,

et al. Improving the quality of reporting of randomizedcontrolled trials. The CONSORT statement. JAMA1996;276:637-9.

5 Rennie D. How to report randomized controlled trials.JAMA1996;276:649.

6 Freemantle N, Mason JM, Haynes A, Eccles MP.

CONSORT: an important step towards evidence-basedhealth care.Ann Intern Med1997;1226:81-2.

Details of patients consent instudies should be reported

EditorMarcel G M Olde Rikkert and col-leagues found that the frequency with whichinformation on informed consent andapproval by an ethics committee was givenin reports of trials was low.1 Browsingthrough various medical journals shows thatthis phenomenon is not limited to geriatrics.Olde Rikkert and colleagues are therefore

right to request more open declarations onwhen and how informed consent was givenor, in special circumstances, why consent wasnot obtained.

Protection of patients rights is increas-ingly important at all stages of medicalresearch.2 Patients have rights to privacythat should not be infringed withoutinformed consent, states the InternationalCommittee of Medical Journal Editors (the

Vancouver Group).3 In the recruitment ofpatients to medical research, informedconsent has long been both a legal require-ment and an ethical imperative. This is

based on the principle that competent indi-viduals should choose freely whether to par-ticipate in research. For all biomedicalresearch involving human subjects, theinvestigator must obtain the informedconsent of the prospective subject or, in thecase of an individual who is not capable ofgiving informed consent, the proxy consentof a properly authorised representative,state international ethical guidelines basedon the Declaration of Helsinki.4

Though consent is normally seen as anabsolute requirement, occasional exceptionsexist in some forms of epidemiologicalresearchfor example, that based solely on

medical records. In some studies full disclo-sure of aims and methods might even jeop-ardise the outcome. Responsible ethicscommittees will consider the differentaspects of patients consent when a study isapproved.4

Securing and declaring consent andapproval of ethics committees are primarilythe responsibility of authors, but editorsshould ensure that details are included inarticles. Editors cannot hide behind theirrefereesas seems to have been the misun-derstanding by the editors questioned byOlde Rikkert and colleagues. Referees areadvisers to the editor, not decision makers.

The final decision whether, and what, topublish is made by the editor. The editor canturn down a paper on ethical grounds even

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though the study has been approved by anethics committee. The editor may evendecide to waive the requirement for suchapproval if he or she considers it warranted.

This gives editors a power that must beexecuted carefully. Open declarationsforexample, on informed consentgive readersan opportunity to see how the ethics ofmedical publishing is handled. Wheninformed consent has been obtained it

should be indicated in the published article,ends the Vancouver Groups statement onpatients rights to privacy.3

Magne Nylenna EditorJournal of the Norwegian Medical Association,PO Box 1152 Sentrum, 0107 Oslo, Norway

1 Olde Rikkert MGM, ten Have HAMJ, Hoefnagels WHL.Informed consent in biomedical studies on aging: surveyof four journals.BMJ1996;313:1117.(2 November.)

2 Goodare H, Smith R. The rights of patients in research.BMJ1995;310:1277-8.

3 International Committee of Medical Journal Editors.Protection of patients right to privacy. BMJ1995;311:1272.

4 Council for International Organisations of MedicalSciences. International ethical guidelines for biomedicalresearch involving human subjects. Geneva: CIOMS, 1993.

TheBMJs Nuremberg issue

Force of moral duty was greater forconscientious objectors

EditorJohn Pembertons letter giving thedetails of the experiments in Sheffield onconscientious objectors during the second

world war has the subtitle Nobody diedduring experiments on vitamin C and

vitamin A intakes in Sheffield.1This impliesthat the risks were less and that in that waythe courage of the subjects was diminished.

The letter is factual and cannot deal with theideas of those concerned.I was brought up in the Plymouth Breth-

ren and agonised with my friends andcontemporaries over the morality of killingfor the sake of our country and to resist evilthough we did not know then just how evilthat evil was. Our discussion went oncontinuously, at length, in depth, and withoutmercy, in the way that young men discusspersonal matters. Several of these youngmen stood out for the truth that they

believed in and refused to have anything todo with fighting or to support it directly. I amcertain that none of them were otherwise less

willing to do their perceived duty than therest of us and to accept the risks involved.Thus I am sure that these Sheffield sub-

jects would have signed informed consentforms as we know them today, and wouldhave accepted any risk then. The fact thatnobody died does not alter the risk. That theresearchers did not do any direct harm orpush the experiment to the point of death is,somehow, the real difference between themand their Nazi contemporaries.

It is hard for people today to understandhow we thought then, and I hope this viewhelps to explain us. The idea that we mightdie a violent and early death because of the

war was common to us all. For those whomight now be called slaves of conscience theforce of our moral duty to accept related

risks was not less: it was perhaps evengreater.G J Addis Consultant physician49 Whittingehame Court, Glasgow G12 0BQ

1 Pemberton J. The BMJs Nuremberg issue. BMJ1997;314:540. (8 February.)

Physicians form of faith is beingreviewed

EditorThe Royal College of Physicians isgrateful to Geoffrey Nicholson for drawingits attention to the form of faith signed byfellows.1 The college has recently adopted astatement of purpose, which reads: Thepurpose of the Royal College of Physiciansof London is to promote health and counterdisease by providing education and supportfor physicians to practise at the higheststandard and through advice to govern-ment, governmental bodies and the public.

Thus its position, both in public and inprivate, is that it stands for the welfare of thepublic it serves, ill or not. Stimulated by

Nicholson, we are reviewing our forms offaith to make sure that they reflect this.D London RegistrarRoyal College of Physicians, London NW1 4LE

1 Nicholson G. The BMJs Nuremberg issue. BMJ1997;314:439. (8 February.)

Arabs were skilled inanaesthesia

EditorAnthony John Carters review ofsedative plants skipped several centuries anddid not mention the Arabic anaesthetic

sponge.1 Opium infusion was known toArab clinicians throughout the middle agesand was used commonly to relieve painassociated with inflammation or proceduressuch as tooth extraction and reduction offractures. Poppy seeds were used in oralperioperative analgesic syrups or paste; their

boiled solution was often used for inhala-tion.

Anaesthesia by inhalation was men-tioned in R Burtons Arabian Nights, and

Theodoric of Bologna (1206-98), whosename is associated with the soporificsponge, got his information from Arabicsources.2 The sponge was steeped inaromatics and soporifics and dried; whenrequired it was moistened and applied to

lips and nostrils. The Arabic innovation wasto immerse the anaesthetic sponge in a

boiled solution made of water with hashish(from Arabic hasheesh), opium (from Arabicafiun), c-hyoscine (from Arabic cit al huscin),and zoan (Arabic for wheat infusion) actingas a carrier for active ingredients after waterevaporation.

Arabs in Andalusia were the pioneers ofartificial ice making. Freezing or rubbing

with ice was used for local anaesthesia inminor external operations. Abdominal sur-gery (laparotomy and caesarean section) waspractised around 900-1000ad and wasdependent on detailed knowledge of

anatomy, anaesthesia, antisepsis, and properinstruments.3

M Al-Fallouji Consultant gastrointestinal surgeonBoston Pilgrim Hospital, Boston, LincolnshirePE21 9QS

1 Carter AJ. Narco sis and night shad e. BMJ1996;313:1630-2.(21-28 December.)

2 Al-Fallouji M. History of surgery of the abdominal cavity:Arabic contributions.Int Surg1993;78:236-8.

3 Al-Fallouji M. Arabic caesarean section. Scott Med J1993;38:3-4.

Promoting health in prisons

Discussion is needed between prisonhealth service and NHS

EditorThe chief inspector of prisonsrecently proposed that the NHS shouldassume responsibility for the delivery of allhealth care, including that required inprisons.1 2 The prison health service under-

Arab clinicians used opium infusions throughout the middle ages

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standably believes that this implies criticismof its previous performance and threatensits future. For example, J M Hall claims thatin many ways the prison healthcare serviceprovides a better service for its patients thandoes the NHS and that the NHS would pro-

vide an inferior service for prisons.3 Perhapsthis view rests on the assumption that theexisting staff would be replaced and theexisting service revamped by people with no

experience of the special problems encoun-tered in prisons.

Prison health care requires special skilland needs to build on the existing base ofcaring staff to provide support and rehabili-tation for inmates. The services problems,however, include isolation and the low payand status of healthcare staff. Prisoners arepart of the general population, who willshortly re-enter societyhopefully, betterable to contribute to it. The provision ofrehabilitation for drug misuse, care and sup-port for those with learning disability orpsychiatric illness, immunisation againsthepatitis B, and health education about

bloodborne viruses are an essential part ofthe care required in prison and are already

being supplied by the service. Acute psychi-atric care is often, however, lacking, becauseNHS psychiatrists may not regard inmatesas their responsibility. Better support fromthe NHS would greatly enhance theeffectiveness of these interventions and pro-

vide seamless care for prisoners movingback into the community.

The chief inspector of prisons advisesdiscussion about urgent, genuine, andlasting improvements, and the prison healthservice should welcome this proposal.Olwen Williams Consultant in clinical effectiveness

Jan Cassidy Prison healthcare audit facilitatorAnglia Clinical Audit and Effectiveness Team, Box111, Clinical School, Addenbrookes Hospital,Cambridge CB2 2SP

1 Inspectorate of Prisons for England and Wales.Patient orprisoner? A new strategy for health care i n pr isons.London:Home Office, 1996.

2 Squires N. Promoting health in prisons. BMJ1996;313:1161.(9 November.)

3 Hall JM. Promoting health in prisons.BMJ1997;314:302.(25 January.)

More resources are needed

EditorI fear that, since the somewhatvacuous statements from the Inspectorate

of Prisons suggesting that the NHS shouldtake over prison care, a predictable argu-ment is developing over whether thehealthcare service for prisoners or the NHS

would provide a better service to patientswho are prisoners.1 2 This is a meaninglessdebate. Having worked in the NHS for 10years and now moved into the healthcareservice for prisoners, I see a great deal oftalent and enthusiasm among medical andnon-medical healthcare staff. What islacking is resources. When this subject israised there is a great temptation amongthose who pass their time by shifting paperin Whitehall to determine that resources do

not count and that the only question iswhich logo should adorn the front door ofthe healthcare centre in prisons, or whether

yet another costly change in managementstructure would improve the likelihood ofpatients receiving adequate care. The resultis that few people in prisons now have theslightest idea of who is responsible for pro-

viding each service.Currently the main lack in the provision

of medical care in my prison is the absenceof any strategy for helping mentally disor-dered offenders. A costed bid to provide this

service, which had the backing of all thehealthcare workers in this establishmentplus the governor, has received no backingat all. Apparently the answer to my problemsis to come from another reorganisation, in

which another tier of management is to beplaced above me and a senior medicalofficer will be added to the healthcareadviser to advise me on how to handle thepsychiatric morbidity at my prison. Needlessto say, my hopes that the senior medicalofficer appointed might work in the samecounty as my patients at the prison haveproved vain. The solution is obvious:providethe doctors and other healthcare staff who

are actually working with patients with theresources necessary to fulfil their roles.

I fear that the problem will continue;while the great and the good spend theirtime arguing over which particular bureau-crat should be managing this structure theyfail to divert their attention and resources tothe people who are the most importantparts of this organisation.S Rossiter Medical officer

Verne Prison, Portland, Dorset DT5 1EQ

1 Squires N. Promoting health in prisons. BMJ1996;313:1161.(9 November.)

2 Hall JM. Promoting health in prisons.BMJ1997;314:302.(25 January.)

Medicosocial aspects ofdepopulation in Belarus

EditorIn 1994 the population of Belarusbegan to decline progressively: during 1994the population fall was 22 200 (0.2% ofinhabitants), in 1995 it was 32 800 (0.35%),and in the first half of 1996 it was 17 300.Such depopulation predominately showsthe demographic consequences of socialpolicy in the former Soviet Union. Cur-rently, during a time of dramatic distur-

bances, a truly vicious circle is operating inthe sick social organism. On the one hand,the social malfunctioning harms the physi-cal and mental health of the nation. On theother hand, national revival requires ahealthy workforce, but the proportion ofable bodied people in the population hassteadily decreased. Furthermore, people liv-ing in a sick social environment oftendevelop stable, psychologically deviant

behaviour, which is usually followed by thedevelopment of pseudosocial norms of

behaviour, thus confirming the existingsocial reality.

Depopulation is an integral process that

reflects the functional exhaustion of thewhole social system, but certain medico-social problems are crucially important.

Firstly, there is the problem of alcoholmisuse. Belarus has the highest indices forthe consumption of alcohol per head ofpopulation among the countries of theCommonwealth of Independent States.1

The increase in mortality, both from naturalcausesfor example, cardiovascular dis-easesand from violence, is mainly caused

by heavy drinking. Lethal alcohol intoxica-tion has become one of the leading causes of

unnatural death in middle aged men. Ingeneral, parental misuse of alcohol hasmore consequences for childrens healthydevelopment than has the Chernobylnuclear disaster. Hard drinking leads tomoral and social degradation of the person,

which adds to the vicious circle mentionedabove.

Secondly, the lack of measures of socialand medical prevention is extremely perni-cious for young people, who now find them-selves in a social and moral vacuum. Most ofthem cannot find any internal, nationallyrelated links with society. As a result, allsocial weakness manifests more sharply inyoung people. Thus, from 1990 to 1992 thesuicide rate among men under 20 doubled.

The spread of antisocial and unhealthybehaviour among young people will consid-erably worsen the demographic situation inthe near future.

Finally, the healthcare system is disas-trous. The weak national health service isincapable of dealing with the increasing

burden of social and ecological problems.Radical changes in health care are neces-sary, but they cannot precede political andeconomic reform.S V Kondrichin Doctorul Krasnoarmeiskaia 34-17, Minsk 220030, Belarus

1 Gosudarstvenniy doclad o soctoyanii zdorovya nase-leniya Rossiiskoi Federatsii v 1992 g. Zdravookhranenie

Rossiiskoi Federatsii1994;3:3-8.

Routine follow up of breastcancer in primary care

EditorThe question of whether and thenhow to follow up patients after the diagnosisof breast cancer and who should do itremains vexingly unanswered by the inad-equacies of retrospective reviews and short

term small prospective studies. Most studiesconcentrate on the efficiency or otherwise ofvarious forms of routine follow up to detectlocal or distant recurrence. Occasionally the

views of patients are surveyed. No studiesseem to address what for me is an equallycrucial issuethe need for clinicians to learnabout the behaviour of this disease and tomeasure, investigate, and understand thephysical and psychological morbidity associ-ated with what doctors and the disease do tothese patients.

Specialists are not created. They do notmysteriously acquire acumen, expertise, andunderstanding overnight when they become

fellows of a royal college. They learn muchas registrars, and that learning does not stopat elevation to consultant.

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When asked by patients why I need tocontinue to see them I gladly inform themthat they do more for me and my juniorsand, hopefully, for other subsequent patientsthan I do for themand I am grateful.

As a result of seeing patients treatedover many years in routine follow up, mycolleagues and I in Edinburgh recognisedmorbidity problems that are associated

with postmastectomy radiotherapy, dis-cussed and then altered the technique andfractionation, and over the subsequent11 years assessed the outcome in termsof local recurrence, survival, and morbidity.1

A policy to devolve follow up to generalpractitioners, who see relatively few

breast cancer patients,2 or to specialistnurses,3 who may have a relatively shortcareer in an institution, or to patientsinclination4 may not be useful in educatingfuture oncologists or re-educating estab-lished ones.Alan Rodger Director of radiation oncology

William Buckland Radiotherapy Centre, Alfred

Hospital, Prahran, Victoria 3181, Australia

1 Rodger A, Jack WJL, Kerr G. A change in post-mastectomy radiotherapy fractionation: an audit oftumour control, acute and late morbidity. Breast1996;5:244-9.

2 Rainsbury D. Routine follow up of breast cancer inprimary care: follow up by non-specialists should not beencouraged.BMJ1996;313:1547.(14 December.)

3 Kunkler I, Tienney A, Jodrell N, Forbes J. Routine followup of breast cancer in primary care: more use should bemade of specialist nurses BMJ 1996;313:1547-8. (14December.)

4 Kirkbridge P, Vallis K. Routine follow up of breast cancerin primary care: study of open access centre for patients

with breast cancer is planned. BMJ1996;313:1547. (14December.)

Second study supports resultsof Whitehall study after

retirement

EditorM G Marmot and Martin JShipleys finding of persistent socio-economic differences in mortality amongmale civil servants beyond retirement ageshas evident implications for social policy

issues.1

We present corroborative evidencefrom the longitudinal study of the Office forNational Statistics. Whereas the Whitehallstudy is based on a sample of civil servants,the longitudinal study is a study of arepresentative 1% sample of the total popu-lation of England and Wales (about 650 000people). Details of the study can be foundelsewhere.2

Current analyses use deaths between1971 and 1992 to compare groups classified

by occupation based social class, housingtenure, and access to a car. Using personyears at risk, we derived standardisedmortality ratios for all causes adjusted for

age and calendar period.3Women are classi-fied by their partners social class, orotherwise by their own. Table 1 shows theeffects of occupation, housing tenure, andaccess to a car after retirement age. Mortalityis uniformly higher among both men and

women without access to a car than amongthose with access to a car, except among

women aged 75 and over who live in localauthority housing and are in a non-manualsocial class. There is also systematic variation

by housing tenure and social class. Marmotand Shipley show that the predictive powerof occupational status fell with age, more

than did that of car ownership. Our analysessuggest that housing tenure may also be animportant indicator of variation in mortalityamong elderly people.

In summary, our work supports Marmotand Shipleys general assertion that house-hold based measures continue to predictrelative differences in mortality after retire-ment.Seeromanie HardingSenior research analyst

Ann Bethune Research analyst

Michael Rosato Senior technical analystOffice for National Statistics, Census, Populationand Health Group, London WC2B 6JP

1 Marmot MG, Shipley MJ. Do socioeconomic differencesin mortality persist after retirement? 25 Year follow up ofcivil servants from the first Whitehall study. BMJ1996;313:1177-80. (9 November.)

2 Hattereley L, Creeser R. Longitudinal study 1971-1991.History, organisation and quality of data.London: HMSO,1995. (Series LS, No 7.)

3 Goldblatt P, Jones D. Methods. In: Goldblatt P, ed.Longitudinal study. Mortality and social organisation.London: HMSO, 1990:51-66.

New Zealand priority criteriaproject

More use should be made of patientoriented quality of life measures

EditorThe New Zealand priority criteriaproject is worthy of wide debate, and Britainhas much to learn from it.1 2 Unlike theapproach taken in Oregon, the projectrecognises that benefits from treatmentdepend on the selection of patients and thethreshold for intervention, which is impor-tant in maximising the health gain from

healthcare resources. The New Zealandapproach also provides a mechanism foraddressing equity based on need rather thanon service measures such as waiting timesand levels of activity.

The criteria used in the project are a mixof symptoms, clinical signs, impairments,and disabilities. However, the symptoms andclinical signs (which are impairments them-selves) account for most of the available 100points, while disability as represented by thecriterion ability to work, care for depend-ants, or live independently can score only10-16 points maximum. This is explained by

the fact that a certain degree of misgivingwas usually noted about incorporating thesesocial factors during the professionaladvisory groups discussions.

This weighting can be criticised becausethe most important criterion for treatment issurely the impact of a condition on apersons lifestyle rather than the simplepresence of a symptom, clinical sign, impair-ment, or disability. A recent survey ofophthalmologists found that most regardeddisability as being more important than

visual acuity when considering whether tooffer cataract extractions3for example, a

visual acuity that would prevent driving has

a much greater impact on someone whosework entails driving than on non-drivers.The imbalance in the New Zealand weight-

Table 1 Standardised mortality ratio (SMR)* for men and women by access to a car, housing tenure,

and social class, according to Office for National Statistics longitudinal study 1971-92. Figures in

parentheses are 95% confidence intervals

Socioeconomic status

Age at death (years)

65-74 (men) or 60-74 (women) >75

Men Women Men Women

Access to a car

Owner occupied housing:

Non-manual 75 (73 to 78) 71 (68 to 74) 82 (79 to 84) 81 (78 to 85)

Manual 83 (80 to 87) 86 (82 to 90) 93 (90 to 97) 88 (84 to 92)

Local authority housing:

Non-manual 90 (81 to 99) 86 (77 to 97) 95 (84 to 107) 97 (83 to 112)Manual 104 (99 to 109) 101 (96 to 107) 105 (99 to 111) 97 (90 to 105)

Privately rented housing:


Manual 100 (94 to 107) 91 (83 to 99) 104 (97 to 112) 100 (91 to 109)

No access to car

Owner occupied housing:


Manual 103 (99 to 107) 101 (96 to 106) 102 (99 to 105) 96 (92 to 99)

Local authority housing:


Manual 122 (118 to 126) 122 (118 to 127) 116 (113 to 120) 107 (103 to 111)

Privately rented housing:


Manual 114 (109 to 120) 110 (104 to 117) 102 (105 to 113) 104 (100 to 108)

*Relative to all men (SMR=100) and all women.SMR significantly different from 100.

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ings might be explained by the fact thatthere are already well known assessmentprocedures with severity gradings for symp-toms and signs. This adds additional weightto the argument that further developmentand greater use of disability or patientoriented quality of life measures areurgently needed in effectiveness and costeffectiveness studies.

Finally, we wish to make a more specific

point. Ocular comorbidity, for which treat-ment is less successful, is usually regarded asa relative contraindication to cataract sur-gery and should not therefore contributepositively to the overall score.Alan Mordue Consultant in public health medicineBorders Health Board, Melrose, Roxburghshire

TD6 9DBDavid W Parkin Senior lecturer in health economicsDepartment of Epidemiology and Public Health,University of Newcastle upon Tyne, Newcastle upon

Tyne NE2 4HH

1 Hadorn DC, Holmes AC. The New Zealand prioritycriteria project. Part 1. Overview. BMJ1997;314:131-4.(11 January.)

2 Hadorn DC, Holmes AC. The New Zealand priority

criteria project. Part 2. Coronary artery bypass graft sur-gery.BMJ1997;314:135-8.(11 January.)

3 Mordue A, Parkin DW, Baxter C, Fawcett G, Stewart M.Thresholds for treatment in cataract surgery. J PublicHealth Med1994;16:393-8.

Project has potential to improve patientcare, but only with injection of funds

EditorThe report by David C Hadornand Andrew C Holmes about the NewZealand priority criteria project implies aconsensus among cardiologists and cardiacsurgeons in New Zealand.1Alas, it is not so.

Between 1990 and 1994 the rate of pub-licly funded coronary bypass surgery in New

Zealand fell by 9% to 33/100 000, while dis-charges from hospital of patients withangina or infarction rose by 19%. There areno plans for any long term increase in ratesof coronary surgery, and patients requiringsurgery are waiting longer.

We have compared a consecutive caseseries of patients referred for isolatedcoronary bypass surgery from ChristchurchHospital (referral base for 500 000 people)

between 1 July and 31 December 19932withtwo Canadian case series.3 4 Of the 88patients accepted for surgery over thisperiod, a quarter had stenoses of >50%diameter in the left main coronary artery

and another three fifths had multivessel dis-ease that included the proximal left anteriordescending coronary artery.2Just over threefifths had angina at rest or on minimal exer-tion. Priority scores used in Ontario5 andNew Zealand1 were applied retrospectively.

The clinical characteristics of the Christ-church and Canadian patients were similar,as were median Ontario priority scores, butNew Zealanders waited a median of 92 dayscompared with 17 days in the largerCanadian series.3 Of the Christchurchpatients waiting at home for surgery, a quar-ter were readmitted with unstable syn-dromes or myocardial infarction before

their surgery. One patient died. Patients withleft main coronary disease waited a medianof 41 days, versus 7 days in Ontario.3

Figure l shows the difference in waitingtimes between our 1993 case series and the

Toronto series reported in 1993,4 withpatients classified according to the Ontariopriority score. The problem is getting worse

in New Zealand: of 415 patients referredfrom Christchurch between 1 January 1994and 31 December 1995, 13 died while onthe waiting list. Patients with left maincoronary disease now wait a median of 73days.

The priority criteria project has thepotential to improve patient care, but only

with the injection of sufficient funds toensure that people who need surgery get it.Our rate of coronary surgery is two thirdsthat in Canada and half that in Australia.Use of the previously validated urgencyscore5 makes it obvious that New Zealanders

wait far too long for bypass surgery. We do

not need a system that solves the problem ofwaiting lists by taking half of the deservingpatients off such lists. There will be moredeaths, more readmissions, and more healthdollars wasted.

John Elliott Cardiologist

Matthew Doogue Trainee intern

Ian Crozier Cardiologist

David Smyth Cardiologist

A Mark Richards Cardiologist

M Gary Nicholls Cardiologist

Hamid Ikram Director of cardiologyDepartment of Medicine, Christchurch School ofMedicine, Christchurch Hospital, PO Box 4345,Christchurch, New Zealand

1 Hadorn DC, Holmes AC. The New Zealand prioritycriteria project. Part 2. Coronary artery bypass graft sur-gery.BMJ1997;314:135-8.(11 January.)

2 Doogue MD,Brett CNH,Elliott JM. Life and death on thewaiting list for coronary bypass surgery. NZ Med J 1997;110:26-30.

3 Naylor CD, Sykora K,Jaglal SB,Jefferson S and the Steer-ing Committee of the Adult Care Network of Ontario.

Waiting for coronary bypass surgery: population-basedstudy of 8517 consecutive patients in Ontario, Canada.

Lancet1995;346:1605-9.4 Naylor CD, Morgan CD, Levinton CM, Wheeler S,

Hunter L, Klymciw K,et al. Waiting for coronary revascu-larization in Toronto: 2 years experience with a regionalreferral office. Can Med Assoc J1993;149:955-62.

5 Naylor CD, Baigre RS, Goldman BS, Basinski A.Assessment of priority for coronary revascularisation

procedures.Lancet1990;335:1070-5.

In Scotland, Mental WelfareCommission inquires intohomicides by psychiatricpatients

EditorElaine Murphy and Louis Applebyand colleagues write about inquiries intohomicides by psychiatric patients.1 2 Ithought it relevant to give some informationabout the situation in Scotland, which com-

bines some of the advantages of the propos-

als in the two letters.In Scotland the Mental Welfare Com-mission has a duty under the Mental Health(Scotland) Act 1984 to inquire into any casein which it seems that there may be adeficiency in care or treatment. This permitsthe commission to make inquiries intohomicides by psychiatric patients as well asinto other potential deficiencies in care. Thisinquiry is normally carried out by commis-sioners and officers of the commission on aninformal and confidential basis, with report-ing to the relevant authorities, although aninquiry into a homicide carried out in 1995at the request of the secretary of state was

made public by him.3

The commission alsohas a power under the act to carry out a for-mal inquiry with the power of a court of law,

but it has not used this yet, regarding it as avaluable reserve power to use if necessary.

I believe that the commissions approachoffers an appropriate and cost effective solu-tion to the need for independent inquiryinto homicide and other situations. (Itshould be remembered that an act in whichthe intention might have been to kill mayprove non-fatal through chance factors.Inquiry into such events is also important.)

There is an advantage in having a singlebody conducting such external inquiries in

terms of the accumulation of experienceand consistency of approach. The commis-sion sees its role as complementary to thenational confidential inquiry into suicideand homicide by people with mental illness,since it is able to take up issues arising fromthe inquiry with organisations and individu-als involved in the previous care of thepatient. A range of professional skill is avail-able within the commission, but the com-mission can also call on external expertevidence if required.

J A T Dyer DirectorMental Welfare Commission for Scotland,Edinburgh EH3 7RN

1 Murphy E. Inquiry into homicides by psychiatric patients.BMJ1997;314:375.( 1 February.)

2 Appleby L, Shaw J, Amos T. Inquiry into homicides bypsychiatric patients.BMJ1997;314:375.( 1 February.)

01 2 3 4 5 6 7 1 2 3 4 5 6 7

Ontario priority score

0

100

200

300

400

500

600

700

800

900

1000

50

100

150

200

Toronto

Christchurch

Waitingtime

(days)

Waitingtime(days)

Fig 1 Waiting times for coronary bypass surgery

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3 Mental Welfare Commission.Report of the enquiry into thecare and treatment of Philip McFadden. Edinburgh: MWC,1995.

Which doctors die first?

Lower mean age at death in doctors ofIndian origin may reflect different agestructures

Editor

In their analysis of the age at deathof doctors in the BMJs obituary columnsD J M Wright and A P Roberts make theclassic and fundamental error of inferringrisk based solely on cases withoutdenominators.1 They confuse lower meanage of death with earlier mortality; differentmean age at death in doctors of Indianorigin compared with doctors of UnitedKingdom origin may, however, simplyreflect differing age structures of the twogroups. In Great Britain the percentages ofthe population aged 60-74 years and over74 years are higher among white people

(14% and 7% respectively) than amongsome other ethnic groups (Indian 6%, 1%;Black African 2%, 1%; Black Caribbean 11%,1%).2 The corresponding estimated medianages are 37, 29, 27, and 31.2

The differing age structures may be dueto differing birth and mortality rates and,more probably, immigration and migrationcohort patterns. The lower proportion ofpeople aged 60 years and over in the Indianand black groups results in lower median ormean age than in white people. Similarly,the lower mean age of death of anaesthetistsis difficult to interpret without knowledge ofthe age distributions of the various special-

ties in medicine.There are undoubtedly ethnic variationsin health.3 However, analyses withoutdenominators are unlikely to provide con-

vincing evidence and may lead to erroneousconclusions.Kay-Tee Khaw ProfessorClinical Gerontology Unit, Addenbrookes Hospital,Cambridge CB2 2QQ

1 Wright DJM, Roberts AP. Which doctors die first? Analy-sis of BMJobituary columns. BMJ1996;313:1581-2.(21-28 December.)

2 Haskey J. The ethnic minority populations of Great Brit-ain: their estimated sizes and age profiles. PopulationTrends1996;84:33-9.

3 Balajaran R. Ethnicity and variations in the nationshealth.Health Trends1995/6;27:114-9.

Recording the doctors sex might have ledauthors to suspect their conclusions

EditorD J M Wright and A P Robertsconclude that anaesthetists died youngerthan those in primary care and thatdoctors from the Indian subcontinent died

before those from the rest of the Englishspeaking world.1Although I realise that theChristmas issue of the BMJis no place forserious science, I would be surprised if inthe future I did not see citations of thesecavalier and erroneous claims. They sufferfrom a classic error of interpretation,2 one

from which two years ago the Lancet alsosuffered indirectly in a lead editorial3 citinga claim, also based on obituary data, 4 that

women doctors died earlier, which wasattributed to greater stress. If Wright andRoberts had recorded the sex of thedoctors, as they should have done, thentheir error might have become more appar-ent and made them suspect the rest of theirconclusions.

There seems little doubt from the datathat anaesthetists, Indian doctors, and

women doctors have an earlier age of death

reported in their obituaries. That is not indispute. But, seemingly paradoxically, thatfinding does not mean that these doctors dierelatively earlier. To show that a group ofindividuals dies earlier one must know theages not only of those who are dead but alsoof those who are alive. Any study carried outnow would find that anaesthetists, Indiandoctors, and women doctors are alsoyounger than other doctors. That is becauseanaesthetics is a relatively young specialty,

because the influx of Indian doctors intoBritain occurred only since the second

world war, and because medical schoolshave only recently admitted many women

medical students. Increased mortality cantherefore be shown only when average ageat death is disproportionately lower than theaverage age of those living.

The fallacy would be readily seen if oneknew whether the doctors whose obituaries

were published owned an Oasis CD, werecalled Tracy or Kevin, had recently becomemembers of the Royal College of Physicians,had done molecular biology research, oreven,dare I suggest it,had published a paperin theBMJ. Each of these subgroups wouldalso have died at an earlier agenot,however, because of those characteristics but

because, as a result of secular changes, theyare markers of coming from a youngercohort and therefore of having a loweraverage age, either in life or at death.Chris McManus Professor of psychologyImperial College School of Medicine at St Marys,London W2 1PD

1 Wright DJM, Roberts AP. Which doctors die first? Analy-sis of BMJ obituary columns. BMJ1996;313:1581-2.(21-28 December.)

2 McManus IC. Increased mortality in women doctors [let-ter].Lancet1995;345:796-7.

3 Burnished or burnt out: the delights and dangers ofworking in health [editorial].Lancet1994;344:1583-4.

4 Falck J, Thiels C.Das Sterbealter der rzte in Berlin-WestundHessen von1964bis 1976.Med Klin1979;74:1140-3.

Authors replyEditorWe were aware of the absence ofdenominators of the age of deaths in thearticle. This caveat had been included in apreliminary draft, but we felt that our admis-sion that the dataset was incomplete for anumber of reasons covered the point. Itmight be argued that when the numerator isdeath, especially if the population issubstantial, then it will affect subsequent agegroups, which would partially compromisethe denominator.

We suggest that a valid denominator, forwhich we know no source, would be thenumber of doctors born in each area and

still living in Britain. The data referred to byProfessor Khaw are not apposite, sincetheyrelate to the group that the respondents

considered they belonged to rather than towhere they were born. The data were alsobased on percentage populations includingage groups for 0-24 years, which weredisproportionately high in the ethnic popu-lations, and white cannot be related toUnited Kingdom as country of origin.

We are also not sure why ProfessorMcManus regards anaesthetics as a youngspecialty as two of the 26 anaesthetists diedat age 92 years and a further three at 88years. The lower mean age was largely aresult of seven dying under the age of 50, of

whom four were aged under 40. The earlierdeath of anaesthetists was first foreshad-owed in a Russian study, when inhalation ofnoxious gases was incriminated.1 If this wasso, why should other theatre staffsuch assurgeonsnot be similarly affected? How-ever, suicide as an alternative explanation

was presented,2 3 a suggestion perhaps re-inforced by a stereotype of anaesthetists astense and introverted, happier with moresolitary rather than social pursuits.4 More

recent studies imply that although doctorshave twice the rate of suicide of a compara-

ble social group, anaesthetists are no moreprone to it than any other members of themedical profession.5 What may be signifi-cant is the increased number of early retire-ments of anaesthetists because of ill healthand the greater number of deaths.5The rea-son for this remains uncertain.D J M WrightReader in medical microbiology

A P Roberts Senior lecturer in medical microbiologyDepartment of Medical Microbiology, CharingCross and Westminster Medical School, London

W6 8RP

1 Vaisman AI. Work in operating theatres and its effect onhealth of anaesthiologists. Eksperimentanaia Khir urgiia

Anesteziologiia1967;12:44-9.2 Low EA. Mortality experience amongst anaesthetists.

Anaesthesiology1979;51:195-9.3 Helliwell PJ. Suicide amongst anaesthetists in training.

Anaesthesia1983;38:1097.4 Bruce DL, Katz, SE, Turndorf H, Trounstine P, Hardesty

A. Psychomatic comparisons of trainees and consultantsin anaesthesia and psychiatry.Br J Anaesth1983;55:1259-64.

5 McNamee R, Keen RI, Corkhill CM. Morbidity and earlyretirement among anaesthetists and other specialists.

Anaesthesia1987;42:133-40.

Correction

Prescribing antidepressants in generalpractice

An editorial error occurred in the fifth letterof this cluster, by Imad M Ali (15 March,p 827). In the last sentence the words stud-ies based on were omitted before patients.

The sentence should have read: Theimportant thing is that studies based onpatients with a diagnosis of depression froma general practitioner (without a concurrentstandardised psychiatric assessment) may beflawed because the concept of depression in

primary care is broad and the use of anti-depressants in itself does not mean thatmajor depression is being treated.

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arabs were skilled in anaesthesia

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