620
Consent to treatment interpretation of the 1985 House of Lords judgment Sidawayv Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others, Dr Heneghan (Feb 16, p 421) may wish to consult Prof Ian Kennedy’s searching analysis. This appeared as a postscript to his paper The Patient on the Clapham Omnibus in the Modern Law Review and reproduced with a postscript in Treat Me Right: Essays in Medical Law and Ethics (Clarendon Press, Oxford, 1988). Kennedy concluded (p 210) that "... the law relating to a doctor’s duty to inform his patient has been cut free from Bolam. Lord Scarman is in the vanguard in recognizing the need for, and validity of, a doctrine of informed consent; Lord Bridge and Lord Templeman in their own ways, and perhaps falteringly, are not so very far behind. The transatlantic doctrine may not have been embraced, but an English variant is certainly in the process of being constructed". Their lordships’ speeches in Sidaway are not free from ambiguity and are open to various interF- etations. Law, not unlike medicine, is a fairly inexact business, and readers of the NHS Management Executive advisory handbook1 should have that observation in mind when reading the interpretation of Sidaway given on p 12. That said, Heneghan goes too far in saying that the Department of Health’s advice is "clearly wrong". The law on consent requires clarification by legislation. Other observations can be made on this advisory handbook. Reference is made to forthcoming circulars on confidentiality, use of disclosure of NHS information, and guidance on local research ethics committees. This publishing activity by the NHS Management Executive does seem to represent government SIR,-For
an
in
incursion into the professional health
care
ethics of doctors and
nurses.
appendix A(3) of the advisory handbook1 there is a model form "For treatment by a health professional other than doctors and dentists". What treatment by a health professional In
consent
other than a doctor or dentist would warrant the use of this form? Medical defence organisations’ guidelines on consent envisage, generally speaking, written consent for major invasive procedures. The Medical Defence Union recommends that written consent be obtained "for all procedures requiring a general anaesthet::; for operations other than minor ones performed under local or regional anaesthesia; for major invasive procedures such as endoscopies, biopsies, etc; for potentially hazardous investigative techniques such as angiography or the use of radio-active isotopes".2 Advice from the Medical Protection Society is similar.3 How does this advice relate to the model consent form in appendix A(3)? Does this form represent an acknowledgement that, as part of their extended role4 nurses are engaged on invasive techniques which require written consent? If a nurse was negligent in obtaining consent, what standard of care would be expected by the court? That of a reasonable nurse in her specialty or from a medical standard? Wilsherv Essex Area Health Authority is authority for the proposition that a medical standard of care could be the appropriate one.5 Nottingham Law School, Nottingham Polytechnic, Nottingham NG1 4BU, UK
Department is "clearly wrong". Heneghan’s views are out of line with mainstream thinking of medical lawyers. The Department’s advice is consistent with the Sidaway decision. Four of the five judges gave reasoned judgments dismissing the claim that a clinician had negligently failed to advise a patient of the risks of injury inherent in a surgical procedure. Interpretation of the case requires a careful synthesis of the often disparate views of these law lords, and this is no easy matter. It is correct that four judges (Lord Scarman disagreed) did not adopt what is sometimes referred to as the North American doctrine of "informed consent" as part of the law of England. This doctrine imposes a legal duty to advise, warn, and counsel patients about those matters which a "prudent" or "reasonable patient" would wish to know before deciding whether to consent to the procedure. However, the House of Lords’ rejection of the doctrine of "informed consent" does not mean that the other polar position was adopted-namely, that a doctor is only required to disclose that which he or the profession (competent medical opinion) would consider it right and/or necessary to reveal. Only Lord Diplock subscribed to this narrow, paternalistic view of the proper balance between doctor and patient. Curiously, the Court of Appeal subsequently applied Lord Diplock’s approach in a failed sterilisation case (Goldv Haringey Health Authority [1987]2 All ER 888). We have no doubt that further consideration of this issue by an appellate court would reject this adherence to Lord Diplock’s view: as Lord Scarman has put it (] R Soc Med 1986; 79:697), "We can ignore Lord Diplock’s opinion, as he was in a minority of one". Nevertheless, the crucial question remains-what is a doctor’s duty to advise and warn his patient? The precise scope of his duty is not clear from the judgments in Sidaway which form, in effect, the common ground between the judges. Lord Bridge’s views are not, as Heneghan claims, in "a minority" nor can they be described as "not an authoritative statement of the law". They are the considered views of a senior law lord with whom one other agreed. Lord Bridge was not content to leave to the medical profession the scope of a doctor’s legal duty to disclose. He considered that the law has the right to override even a unanimous medical view if the court considers non-disclosure unjustified. The writing is on the wall for those who believe, in Heneghan’s words, that "it is a matter of professional judgment what doctors should tell the patient". The views of the medical profession here are certainly relevant but they are no longer conclusive. The law has moved on in Sidaway, and the Department’s documents seek to reflect this. Similarly, Lord Templeman rejected the view that "the doctor is entitled to decide everything". He would require a doctor to disclose any risks "special in kind or magnitude as special to the patient", and to do so even if the medical practice is not to disclose these risks. The Department’s attempt to reflect the common legal ground in Sidaway shadows the difficulties facing lawyers. When is a risk "so obviously necessary" or "special"? There are no precise rules. Precision is unobtainable; only future cases can help to unpack the generalised statements of the law by England’s highest court. In attempting this task, the Department’s documents do not get it wrong.
J. H. TINGLE
1. NHS Management Executive. A guide to consent for examination or treatment. Handbook: HC(90)22. London: Department of Health, 1990. 2. Medical Defence Society. Consent to treatment. London: Medical Defence Union, 1986. 3. Medical Protection Society. Consent, confidentiality, disclosure of medical records. London: Medical Protection Society, 1988. 4. Department of Health. Extended role of the nurse: report of a joint working party set up by the Standing Medical Advisory Committee, Standing Nursing Midwifery Advisory Committee (PL/CMO[89]7). London: Department of Health, 1989. 5. Tingle JH. Junior doctor’s standard of care. Lancet 1988; i: 999-1000.
SIR,—Dr Heneghan suggests that Department of Health
publications on consent to examination or treatment overstate a doctor’s legal obligation to advise his patient, in particular when it is said that "where treatment carries substantial risks the patient must be advised of this by a doctor so that consent may be wellinformed". Heneghan draws on the House of Lords decision in Sidaway v Bethlem Royal Hospital which, he states, shows that the
Centre of Medical Law and Ethics,
King’s College, University of London, London WC2R 2LS, UK
ANDREW GRUBB IAN KENNEDY
Misconduct in medical research SIR,—Your note draws attention to a Royal College of Physicians working-party suggesting that university departments should appoint screeners to investigate allegations of misconduct. A recent well-publicised example in the United States illustrated the fallacy of such a concept when a university went to considerable lengths to stop a junior exposing her professor for theft of intellectual property. As a general rule the establishment does not wish to admit that its staff can be guilty of such conduct if this can be avoided. Readers of Acta Neurologica Scandinavica1,2 will be aware of a further example of such conduct exposed in the columns of that journal. When this was drawn to the attention of the relevant university authorities the reply was "no impropriety has occurred".
621
This would suggest a score of two out of two against universities as upholders of intellectual standards of honesty. It leaves the victim of such theft very much in the cold. Broom Lodge, 58 High Street,
Hemingford Grey,
J. M. WALSHE
Huntingdon PE189BN, UK
TR, Berrios GE Wilson’s disease: clinical groups in 400 Scand 1989; 80: 527-34. 2. Scheinberg IH. Acta Neurol Scand 1990; 81: 556-57. 1. Dening
cases.
Acta Neurol
Storage of information by medical journals SIR,-Like you in your Nov 17 editorial "Brevity in The Lancet" decided to "store, rather than print, the fine detail" of certain articles which we call, in their published form, Technical Briefs. We we
have published 5-10 in each monthly issue since 1986. We have been surprised at the rarity of requests for these stored details: among several hundred Technical Briefs published so far, we have received only one such request. Of course, we do not know the frequency with which authors are contacted directly by interested readers. Clinical Chemistry, University of Virginia, Charlottesville, VA 22908, USA
DAVID E.
BRUNS,
Editor
Placental localisation in early pregnancy SIR,—I disagree with the statement in your Feb 2 editorial that "placental localisation at the initial scan cannot be recommended, and when a low placenta is noted incidentally, it is not necessary routinely to order a third-trimester scan". Having been in practice as an obstetrician gynaecologist, and specialising solely in prenatal diagnosis for the past 10 years, it is my experience that the advent of new equipment certainly results in better visualisation for sonograms done in the first and early second trimester, especially with respect to the high instance of diagnosis of low-lying placenta. I believe that the term placenta praevia is inappropriate before 12 weeks’ gestation, unless placental tissue can be clearly seen to cover the internal os region. It is regarded as routine to always visualise the internal os and the whole endocervical canal with an empty bladder to prevent any anatomical distortions. Central placenta praevia can be diagnosed in early pregnancy, especially when the relation of the placental tissue to the os and the endocervical canal is noted. In my experience with these cases, usually without any further abnormal bleeding, repeat sonography between 16 and 18 weeks’ or as late as 20 weeks’ gestation, allows further confirmation of persistent praevia. Prenatal diagnosis is routinely recommended for all women aged 35, when the incidence of chromosome abnormalities is 1 %. Surely central placenta praevia with a population frequency of less than 1 % or a delivery frequency of placenta praevia, which you cite as anything from 2-3% to 169%, warrants a routine repeat sonogram when in early pregnancy the placenta is seen to be overlying the os? Koala Labs, San Jose, Ca 95128, USA
JOHN D. STEPHENS
Different hantavirus serotypes in western
Europe SIR,—SO far, human infections with hantavirus, causing haemorrhagic fever with renal syndrome (HFRS), other than those transmitted by laboratory animals, have in western Europe been associated with serotype III.1,2 The main reservoir host is the red bank vole Clethrionomys glareolus. In the Netherlands we have found serological evidence for serotype III in people who were probably infected via contact with wild rodents.3 We have now demonstrated this virus in animals. In lung extracts of four seropositive red bank voles caught in an area of the Netherlands where eight confirmed human cases of HFRS had been documented, viral antigen was identified by ELISA. The ELISA identified the virus as serotype III z
titres of human sera in ELISA, measured against hantavirus serotype I. serotype III, and strain Dobrava.
Antibody
(A) 11 sera from laboratory-associated cases and (B) 16 sera from non-laboratory-associated cases in Netherlands and Belgium; and (C) 32 sera from non-laboratory-associated cases in Yugoslavia. With the same ELISA system we have tested 32 immunofluorescent antibody positive sera, collected from people a non-laboratory-associated infection in Yugoslavia, against serotype I (strain HV 76-118) which strongly cross-reacts with serotype II (SR-11), serotype III (Hallnas), and a recent isolate from Yugoslavia (strain Dobrava).’ The Dobrava strain was isolated from the yellow-necked field mouse (Apodemus flavicollis) during a recent period of high incidence of HFRS in Yugoslavia;4 it reacted more strongly with sera specific for serotypes I and II than with sera specific for serotype III. In addition 16 positive sera from non-laboratory-associated infections and 11 positive sera from laboratory-associated infections in the Netherlands and Belgium were tested in the ELISA against these three viruses. All sera from the laboratory-associated infections showed higher titres against serotype I and strain Dobrava than against serotype III (figure, A). The titres of these sera against serotype I were slightly higher than those against strain Dobrava. All but 2 of the 16 sera from non-laboratory-associated infections in the Netherlands and Belgium showed the highest titres against hantavirus serotype III (figure, B). 14 of the 32 sera from Yugoslavia showed the highest titres against serotype I and strain Dobrava, whereas the other 18 reacted more strongly against serotype III (figure, C). This confirms the results of an earlier serological study with an IFA,
with
Consent to treatment interpretation of the 1985 House of Lords judgment Sidawayv Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others, Dr Heneghan (Feb 16, p 421) may wish to consult Prof Ian Kennedy’s searching analysis. This appeared as a postscript to his paper The Patient on the Clapham Omnibus in the Modern Law Review and reproduced with a postscript in Treat Me Right: Essays in Medical Law and Ethics (Clarendon Press, Oxford, 1988). Kennedy concluded (p 210) that "... the law relating to a doctor’s duty to inform his patient has been cut free from Bolam. Lord Scarman is in the vanguard in recognizing the need for, and validity of, a doctrine of informed consent; Lord Bridge and Lord Templeman in their own ways, and perhaps falteringly, are not so very far behind. The transatlantic doctrine may not have been embraced, but an English variant is certainly in the process of being constructed". Their lordships’ speeches in Sidaway are not free from ambiguity and are open to various interF- etations. Law, not unlike medicine, is a fairly inexact business, and readers of the NHS Management Executive advisory handbook1 should have that observation in mind when reading the interpretation of Sidaway given on p 12. That said, Heneghan goes too far in saying that the Department of Health’s advice is "clearly wrong". The law on consent requires clarification by legislation. Other observations can be made on this advisory handbook. Reference is made to forthcoming circulars on confidentiality, use of disclosure of NHS information, and guidance on local research ethics committees. This publishing activity by the NHS Management Executive does seem to represent government SIR,-For
an
in
incursion into the professional health
care
ethics of doctors and
nurses.
appendix A(3) of the advisory handbook1 there is a model form "For treatment by a health professional other than doctors and dentists". What treatment by a health professional In
consent
other than a doctor or dentist would warrant the use of this form? Medical defence organisations’ guidelines on consent envisage, generally speaking, written consent for major invasive procedures. The Medical Defence Union recommends that written consent be obtained "for all procedures requiring a general anaesthet::; for operations other than minor ones performed under local or regional anaesthesia; for major invasive procedures such as endoscopies, biopsies, etc; for potentially hazardous investigative techniques such as angiography or the use of radio-active isotopes".2 Advice from the Medical Protection Society is similar.3 How does this advice relate to the model consent form in appendix A(3)? Does this form represent an acknowledgement that, as part of their extended role4 nurses are engaged on invasive techniques which require written consent? If a nurse was negligent in obtaining consent, what standard of care would be expected by the court? That of a reasonable nurse in her specialty or from a medical standard? Wilsherv Essex Area Health Authority is authority for the proposition that a medical standard of care could be the appropriate one.5 Nottingham Law School, Nottingham Polytechnic, Nottingham NG1 4BU, UK
Department is "clearly wrong". Heneghan’s views are out of line with mainstream thinking of medical lawyers. The Department’s advice is consistent with the Sidaway decision. Four of the five judges gave reasoned judgments dismissing the claim that a clinician had negligently failed to advise a patient of the risks of injury inherent in a surgical procedure. Interpretation of the case requires a careful synthesis of the often disparate views of these law lords, and this is no easy matter. It is correct that four judges (Lord Scarman disagreed) did not adopt what is sometimes referred to as the North American doctrine of "informed consent" as part of the law of England. This doctrine imposes a legal duty to advise, warn, and counsel patients about those matters which a "prudent" or "reasonable patient" would wish to know before deciding whether to consent to the procedure. However, the House of Lords’ rejection of the doctrine of "informed consent" does not mean that the other polar position was adopted-namely, that a doctor is only required to disclose that which he or the profession (competent medical opinion) would consider it right and/or necessary to reveal. Only Lord Diplock subscribed to this narrow, paternalistic view of the proper balance between doctor and patient. Curiously, the Court of Appeal subsequently applied Lord Diplock’s approach in a failed sterilisation case (Goldv Haringey Health Authority [1987]2 All ER 888). We have no doubt that further consideration of this issue by an appellate court would reject this adherence to Lord Diplock’s view: as Lord Scarman has put it (] R Soc Med 1986; 79:697), "We can ignore Lord Diplock’s opinion, as he was in a minority of one". Nevertheless, the crucial question remains-what is a doctor’s duty to advise and warn his patient? The precise scope of his duty is not clear from the judgments in Sidaway which form, in effect, the common ground between the judges. Lord Bridge’s views are not, as Heneghan claims, in "a minority" nor can they be described as "not an authoritative statement of the law". They are the considered views of a senior law lord with whom one other agreed. Lord Bridge was not content to leave to the medical profession the scope of a doctor’s legal duty to disclose. He considered that the law has the right to override even a unanimous medical view if the court considers non-disclosure unjustified. The writing is on the wall for those who believe, in Heneghan’s words, that "it is a matter of professional judgment what doctors should tell the patient". The views of the medical profession here are certainly relevant but they are no longer conclusive. The law has moved on in Sidaway, and the Department’s documents seek to reflect this. Similarly, Lord Templeman rejected the view that "the doctor is entitled to decide everything". He would require a doctor to disclose any risks "special in kind or magnitude as special to the patient", and to do so even if the medical practice is not to disclose these risks. The Department’s attempt to reflect the common legal ground in Sidaway shadows the difficulties facing lawyers. When is a risk "so obviously necessary" or "special"? There are no precise rules. Precision is unobtainable; only future cases can help to unpack the generalised statements of the law by England’s highest court. In attempting this task, the Department’s documents do not get it wrong.
J. H. TINGLE
1. NHS Management Executive. A guide to consent for examination or treatment. Handbook: HC(90)22. London: Department of Health, 1990. 2. Medical Defence Society. Consent to treatment. London: Medical Defence Union, 1986. 3. Medical Protection Society. Consent, confidentiality, disclosure of medical records. London: Medical Protection Society, 1988. 4. Department of Health. Extended role of the nurse: report of a joint working party set up by the Standing Medical Advisory Committee, Standing Nursing Midwifery Advisory Committee (PL/CMO[89]7). London: Department of Health, 1989. 5. Tingle JH. Junior doctor’s standard of care. Lancet 1988; i: 999-1000.
SIR,—Dr Heneghan suggests that Department of Health
publications on consent to examination or treatment overstate a doctor’s legal obligation to advise his patient, in particular when it is said that "where treatment carries substantial risks the patient must be advised of this by a doctor so that consent may be wellinformed". Heneghan draws on the House of Lords decision in Sidaway v Bethlem Royal Hospital which, he states, shows that the
Centre of Medical Law and Ethics,
King’s College, University of London, London WC2R 2LS, UK
ANDREW GRUBB IAN KENNEDY
Misconduct in medical research SIR,—Your note draws attention to a Royal College of Physicians working-party suggesting that university departments should appoint screeners to investigate allegations of misconduct. A recent well-publicised example in the United States illustrated the fallacy of such a concept when a university went to considerable lengths to stop a junior exposing her professor for theft of intellectual property. As a general rule the establishment does not wish to admit that its staff can be guilty of such conduct if this can be avoided. Readers of Acta Neurologica Scandinavica1,2 will be aware of a further example of such conduct exposed in the columns of that journal. When this was drawn to the attention of the relevant university authorities the reply was "no impropriety has occurred".
621
This would suggest a score of two out of two against universities as upholders of intellectual standards of honesty. It leaves the victim of such theft very much in the cold. Broom Lodge, 58 High Street,
Hemingford Grey,
J. M. WALSHE
Huntingdon PE189BN, UK
TR, Berrios GE Wilson’s disease: clinical groups in 400 Scand 1989; 80: 527-34. 2. Scheinberg IH. Acta Neurol Scand 1990; 81: 556-57. 1. Dening
cases.
Acta Neurol
Storage of information by medical journals SIR,-Like you in your Nov 17 editorial "Brevity in The Lancet" decided to "store, rather than print, the fine detail" of certain articles which we call, in their published form, Technical Briefs. We we
have published 5-10 in each monthly issue since 1986. We have been surprised at the rarity of requests for these stored details: among several hundred Technical Briefs published so far, we have received only one such request. Of course, we do not know the frequency with which authors are contacted directly by interested readers. Clinical Chemistry, University of Virginia, Charlottesville, VA 22908, USA
DAVID E.
BRUNS,
Editor
Placental localisation in early pregnancy SIR,—I disagree with the statement in your Feb 2 editorial that "placental localisation at the initial scan cannot be recommended, and when a low placenta is noted incidentally, it is not necessary routinely to order a third-trimester scan". Having been in practice as an obstetrician gynaecologist, and specialising solely in prenatal diagnosis for the past 10 years, it is my experience that the advent of new equipment certainly results in better visualisation for sonograms done in the first and early second trimester, especially with respect to the high instance of diagnosis of low-lying placenta. I believe that the term placenta praevia is inappropriate before 12 weeks’ gestation, unless placental tissue can be clearly seen to cover the internal os region. It is regarded as routine to always visualise the internal os and the whole endocervical canal with an empty bladder to prevent any anatomical distortions. Central placenta praevia can be diagnosed in early pregnancy, especially when the relation of the placental tissue to the os and the endocervical canal is noted. In my experience with these cases, usually without any further abnormal bleeding, repeat sonography between 16 and 18 weeks’ or as late as 20 weeks’ gestation, allows further confirmation of persistent praevia. Prenatal diagnosis is routinely recommended for all women aged 35, when the incidence of chromosome abnormalities is 1 %. Surely central placenta praevia with a population frequency of less than 1 % or a delivery frequency of placenta praevia, which you cite as anything from 2-3% to 169%, warrants a routine repeat sonogram when in early pregnancy the placenta is seen to be overlying the os? Koala Labs, San Jose, Ca 95128, USA
JOHN D. STEPHENS
Different hantavirus serotypes in western
Europe SIR,—SO far, human infections with hantavirus, causing haemorrhagic fever with renal syndrome (HFRS), other than those transmitted by laboratory animals, have in western Europe been associated with serotype III.1,2 The main reservoir host is the red bank vole Clethrionomys glareolus. In the Netherlands we have found serological evidence for serotype III in people who were probably infected via contact with wild rodents.3 We have now demonstrated this virus in animals. In lung extracts of four seropositive red bank voles caught in an area of the Netherlands where eight confirmed human cases of HFRS had been documented, viral antigen was identified by ELISA. The ELISA identified the virus as serotype III z
titres of human sera in ELISA, measured against hantavirus serotype I. serotype III, and strain Dobrava.
Antibody
(A) 11 sera from laboratory-associated cases and (B) 16 sera from non-laboratory-associated cases in Netherlands and Belgium; and (C) 32 sera from non-laboratory-associated cases in Yugoslavia. With the same ELISA system we have tested 32 immunofluorescent antibody positive sera, collected from people a non-laboratory-associated infection in Yugoslavia, against serotype I (strain HV 76-118) which strongly cross-reacts with serotype II (SR-11), serotype III (Hallnas), and a recent isolate from Yugoslavia (strain Dobrava).’ The Dobrava strain was isolated from the yellow-necked field mouse (Apodemus flavicollis) during a recent period of high incidence of HFRS in Yugoslavia;4 it reacted more strongly with sera specific for serotypes I and II than with sera specific for serotype III. In addition 16 positive sera from non-laboratory-associated infections and 11 positive sera from laboratory-associated infections in the Netherlands and Belgium were tested in the ELISA against these three viruses. All sera from the laboratory-associated infections showed higher titres against serotype I and strain Dobrava than against serotype III (figure, A). The titres of these sera against serotype I were slightly higher than those against strain Dobrava. All but 2 of the 16 sera from non-laboratory-associated infections in the Netherlands and Belgium showed the highest titres against hantavirus serotype III (figure, B). 14 of the 32 sera from Yugoslavia showed the highest titres against serotype I and strain Dobrava, whereas the other 18 reacted more strongly against serotype III (figure, C). This confirms the results of an earlier serological study with an IFA,
with
