929

Randomised surgical trials

SiR-The prospective randomised clinical trial is scientifically ,

better than other forms of clinical trials, and for medicaltreatments is widely accepted. However, as you imply in your ;

July 24 editorial, such trials are rare in surgery and there arealmost no publications of surgical randomised trials.’ ,

Randomisation of patients, operations, and especiallysurgeons, is still controversiaLZ>3 In a randomised study toestablish whether bone cement is beneficial in total hipreplacement, we found that, apart from the ethical dilemma(which applies also to medical randomised trials), specialdifficulties may apply in surgery.’ Operative treatment is

irreversible, whereas drug trials have a predetermined escapeclause for individuals with an unsatisfactory response.Furthermore, all individuals have the right to withdraw from astudy at any time, without prejudice. In surgical trials,however, because surgery cannot be reversed, an escape clauseis meaningless and may increase rather than diminish theethical dilemma confronting a surgeon.2 Surgery carriesimmediate risks. Surgeons are personally and legallyresponsible for their patients, and morbidity and deathsresulting from the operative procedure are usually attributed tothe surgeon by patients, lawyers, and surgeons themselves.Any failure is more likely to be seen as a shortcoming of thesurgeon, rather than of the method. Surgery requires technicaltraining, and involves more physical expertise than does theadministration of drugs. A surgeon’s level of technical skill forboth tested procedures is usually not equivalent. Therefore,performance bias can result, which cannot be neutralised byblinding. This systematic bias favours technically simpleroperations and those in wider use.4 Surgeons usually have apersonal preference for one operation, or may believe oneoperation is better than another. Surgical scars make blindassessment of the outcome almost impossible.

Certainly, surgical randomised trials cannot be modelled ondrug trials without modifications. Korn and Baumrind4

proposed that only patients should be randomised, not

clinicians and treatments. Thus eligible patients would beassigned to similar surgeon groups, and each group wouldoperate according to their preference or expertise. Althoughthe method can solve most of the difficulties, there is no easymeans in practice because some procedures are more

complicated and more costly than others, and their use can berestricted by several factors. The scientific basis of randomisedclinical trials is group comparability, blind assessment, andobjective evaluation. No trial design has yet met the specificrequirements of surgery. However, adoption of these

proposals, especially comparability, might greatly improve thevalue of non-randomised controlled surgical studies.

Shi-Min ChangDepartment of Orthopaedics, Eighty Fifth Hospital, Shanghai 200052,People’s Republic of China

1 Gross M. A critique of methodologies used in clinical studies ofhip-joint arthroplasty published in the English-language orthopaedicliterature. J Bone Joint Surg 1988; 70A: 1364-71.

2 Van der Linden. Pitfalls in randomised surgical trials. Surgery 1980;87: 258-62.

3 Rudicel S, Esdaile J. The randomised clinical trial in orthopaedics:obligation or option? J Bone Joint Surg 1985; 67A: 1284-93.

4 Korn EL, Baumrind S. Randomised clinical trials with clinician-preferred treatment. Lancet 1991; 337: 149-52.

Ethics and late termination of pregnancy

SIR-Lilford and Thornton (Aug 21, p 499) draw attention tothe complex ethical difficulties that surround termination ofpregnancy. In the UK, abortion has only ever been legal onmedical grounds, which has always required doctors to make

value judgments. Whether a woman seeking abortion issuccessful has much to do with the religious or moral attitudesof the gynaecologist to whom she is referred. Lilford andThornton illustrate this when they suggest that Klinefeltersyndrome is not sufficiently serious to justify third-trimesterfeticide. Present legislation does not differentiate between fetalabnormalities that are or are not serious enough to justify latetermination of pregnancy. Feticide is feticide, whether at 12weeks’ or 32 weeks’. There should therefore be no fetal

abnormality for which termination is available in the first butnot in the third trimester. In my view Klinefelter syndromeshould never be an indication to terminate a pregnancy. The

psychological effect that it might have on the mother might bean indication and in that case the law would restrict abortion tobefore 24 weeks’.

Careful consideration of why an abnormal pregnancy is to beterminated may help to resolve the difficulties in some cases.Clause E of the revised Abortion Act implies that a pregnancymay be terminated, to the benefit of the fetus, where there is arisk of serious handicap. I agree with Lilford and Thorntonthat termination of a trisomy 18 pregnancy is acceptable at anytime, under this clause, because it is better for the fetus not to beborn alive. Trisomy 21 is a different situation. People withDown’s syndrome can, with appropriate social support, livehappy and fulfilled lives. In my opinion we terminate trisomy21 pregnancies, not for the benefit of the fetus, but because ofits psychological effect on the mother. Pregnancy terminationfor Down’s syndrome should therefore be restricted to 24weeks’.

Similar difficulties arise in connection with earlier

termination of pregnancy on the grounds of risk to the mother’smental health. Many gynaecologists will agree to terminate apregnancy before 12 weeks’ virtually at the woman’s requestbut will refuse once the pregnancy has reached its 13th week.The Abortion Act does not differentiate between indicationsbefore and after 12 weeks. It therefore follows that if abortion isavailable on the flimsiest of grounds before 12 weeks’ it shouldbe as readily available between 13 and 24 weeks’. Nevertheless,after 12 weeks’ many gynaecologists become moral

entrepreneurs and will refuse to terminate the unwanted

pregnancy of inarticulate, socially disadvantaged womenwhilst agreeing to requests from women in the uppersocioeconomic groups who elicit greater sympathy and presenttheir case more eloquently. The present legal position, in whichtwo medical practitioners "decide" who may or may not havean abortion is anachronistic. A doctor cannot gain any realinsight into a woman’s social position, her mental state, or theeffects that an unwanted or abnormal pregnancy will have uponher in a consultation lasting for a few minutes. Doctors are nottrained to interpret the law and have no right to make moral orethical judgments on behalf of society in general. Althoughhealth care professionals should play an important part incounselling, it is the pregnant woman who should finally makethe decision. Our abortion legislation needs to be modified totake the views of the woman herself into consideration.

Phillip BennettInstitute of Obstetrics and Gynaecology, Queen Charlotte’s and Chelsea Hospital,London W6 OXG, UK

SIR—We share Lilford and Thornton’s suspicion that"... thesubject of feticide beyond 24 weeks’ gestational age will sooncome to public attention in some, perhaps, dramatic way...".Section l(l)(b) of the Human Fertilisation and EmbryologyAct (HFEA) 1990 provides for termination of pregnancywithout time limit if termination "... is necessary to preventgrave permanent injury to the physical or mental health of thepregnant woman", thus allowing feticide and termination ofpregnancy after 24 weeks of gestation in women with physicalillnesses such as eclampsia and renal disease. As far as we are

930

aware, no case has been reported in which feticide andtermination of pregnancy have been considered or done to

prevent grave permanent injury to the mental health of thepregnant woman.A 19-year-old woman was referred to psychiatrists in the

25th week of her pregnancy, allegedly a contraceptive failure,with a two-week history of depressive symptoms, repeatedlyhammering her abdomen to abort the baby, assaulting herpartner, and threatening suicide if she was refused termination.Having decided against termination of pregnancy at 9 weeks’gestation, she had attended all her antenatal appointments, andan ultrasonographic examination at 24 weeks’ showed a viablefetus with no abnormalities. After considering section 1(1)(b)of the HFEA we refused her request on the grounds that wethought her to be in a situational crisis with high risk ofpost-termination psychiatric disturbance.1 She refused otheroptions including carrying the baby to term for adoption andinpatient psychiatric support. Because she was a seriousimmediate risk to herself and her baby in terms of deliberateself-harm and suicide, she was detained involuntarily undersection 2 of the Mental Health Act (MHA) 1983. During a shortstay in hospital she reconsidered her earlier decision havingbeen assured of her partner’s, and his family’s, immediate andlong-term support. No longer a suicidal risk, she was

discharged to psychiatric outpatient follow-up and continuingantenatal care.

Although comment and discussion generated by the HFEA1990 has focused on treatment of infertility, 2.3 the law allowingfeticide and termination of pregnancy to prevent grave

permanent injury to the mental health of the pregnant womanhas not been scrutinised. What constitutes a "grave permanentinjury" to physical and mental health is open to subjectiveinterpretation and has been described as a "severe legal test"/ 4We cannot envisage a clinical situation in which a psychiatristwould be able, and, indeed willing, to predict that continuationof pregnancy after 24 weeks would result in grave permanentinjury to the mental health of the pregnant woman. In case ofimminent suicide, it could be argued that section 1(4) of theAbortion Act 1967, which allows for termination of pregnancywhere it is "immediately necessary to save the life or to preventgrave permanent injury to the physical or mental health of thepregnant woman", can be invoked; however, it is far morelikely that she would be detained under the MHA 1983-as inour case. Even if past history or continuing psychiatric disorderwere to enable prediction of a post-partum exacerbation andrisk to the life of the baby, would a psychiatrist certify thatfeticide was justified? We think not. But the existing legislationdoes allow for it and we call for an urgent review of this

ambiguous provision.

Naresh Gandhi, Ulrike Schmidt, Javid Rizvi, Farrukh Alam,Nasir Izhar

Academic Department of Psychiatry, Department of Psychiatry, and AcademicDepartment of Obstetrics and Gynaecology, St Mary’s Hospital Medical School,London W2 1NY, UK

1 Dagg PK. The psychological sequelae of therapeutic abortion: deniedand completed. Am J Psychiatry 1991; 148: 578-85.

2 Samuels A, Barrister JP. Embryo research: the significance of the newlaw. Med Sci Law 1991; 31: 115-18.

3 Philipp EE. Impact of the Human Fertilisation and Embryology Act(1990) on the practice of reproductive medicine in the UnitedKingdom. Fertil Steril 1993; 59: 285-87.

4 House of Commons, Official Report June 21, 1990, col 1185.

SiR-Lilford and Thornton are concerned that even fullycounselled parents sometimes make an unambiguous requestfor late abortion (which they term third-trimester feticide) forcongenital abnormalities that are severe but not necessarilylethal in the short term. It is, of course, precisely because thecondition may be long-term that parents are often so concerned

to obtain an abortion, a point that seems to have escaped yourcorrespondents. They say that they have established aninformal ethics committee at their hospital to advise them onthese matters, and they call for advice from doctors, lawyers,and philosphers-not only British but also French. They donot seem to wish to be advised by any parents who have had tospend a lifetime caring for a child with a condition that theparents regard as serious, even though Lilford and Thorntonmay not. May I therefore suggest that they and their colleaguescould be more usefully advised by British parents rather thanby French philosophers, who are not perhaps particularly wellplaced to appreciate the realities of the diminishing social,economic, and educational support available to parents ofhandicapped children in the UK today.

Madeleine Simms17 Dunstan Road, London NW11 8AG, UK

Originality: who Is to judge?SiR-Collier and Vallance (Aug 28, p 510) claim that it isdifficult to assess originality. But there are some reliable tests.One is to submit your ideas to a reputable journal as a

hypothesis. If the paper is accepted then it certainly is notoriginal; if it is rejected then it might be. Another approach is tosubmit your work to peer review or even better to a committeeof experts. If the work receives acclaim then it means that it is

part of the conventional wisdom, and is not original. If rejectedit might be original; if dismissed out of hand, it probably is. Thethird, and most reliable, method is to present your work as aposter at a meeting. If nobody comes to view it, it means thatnobody else is working in the field and your work is original-itmight even be important. If a crowd gathers it is because theyare all doing the same work as you.

J Morris

Department of Pathology, Lancaster Moor Hospital, Lancaster LA1 3JR, UK

International disease counting form

SIR-"The price of health, like that of liberty, is eternal

vigilance".1 Despite this recognition there have been fewcost-effective, accurate systems for disease monitoring locally,nationally, and internationally. Recently, however, there hasbeen an awareness of the need to begin to establish globaldisease monitoring systems to estimate the incidence of bothserious communicable and non-communicable diseases.2,3 The

technologies for cost-effective, accurate disease monitoringsystems are now available through approaches to evaluatethe degree of underascertainment of cases,4,5 and throughtelecommunications systems for rapid information gatheringand transfer of data.

Before considering broad monitoring of diseases there needsto be a standardised international disease counting formespecially for non-communicable diseases so that theinformation recorded from Nigeria, for example, is the same asfrom the UK. We have devised a form that includes the coreinformation that would be needed for monitoring the incidenceof all serious diseases within a country.* *The aim of the system is to achieve accurate incidence rates

for monitoring and forecasting patterns of diseases acrossgeographical area, and across time. To accomplish this end it isnecessary to classify the disease; therefore the first piece ofinformation needed would be the diagnosis. The inputcomputer generates the International Classification of Diseasecode.6 In addition, the date of diagnosis and the place ofdiagnosis of disease would be collected in a standardised